RICE FOOD- oryza sativa solution 
RYE FOOD- secale cereale solution 
SESAME SEED- sesamum indicum solution 
BROCCOLI- brassica oleracea var. botrytis solution 
BUCKWHEAT- fagopyrum esculentum solution 
CASHEW NUT- anacardium occidentale solution 
CAULIFLOWER- brassica oleracea var. botrytis solution 
CHOCOLATE CACAO BEAN- theobroma cacao solution 
CANTALOUPE MUSKMELON- cucumis melo solution 
CARROT- daucus carota solution 
CELERY- apium graveolens var. dulce solution 
LETTUCE- lactuca sativa solution 
FILBERT HAZELNUT FOOD- corylus americana solution 
VANILLA- vanilla planifolia solution 
WHOLE WHEAT- triticum aestivum solution 
APRICOT- prunus armeniaca solution 
WHOLE GRAIN BARLEY- hordeum vulgare solution 
NAVY BEAN- phaseolus vulgaris solution 
STRING GREEN BEAN- phaseolus vulgaris solution 
CABBAGE- brassica oleracea var. capitata solution 
CINNAMON- cinnamomum verum solution 
COFFEE- coffea arabica solution 
MUSHROOM- agaricus campestris solution 
MUSTARD FOOD- sinapis alba solution 
BANANA- musa acuminata solution 
COCONUT- cocos nucifera solution 
CORN FOOD- zea mays solution 
MALT- hordeum vulgare solution 
BLACK PEPPER- piper nigrum solution 
LEMON- citrus x limon solution 
OAT FOOD- avena sativa solution 
ONION- allium cepa solution 
CUCUMBER- cucumis sativus solution 
BLUEBERRY- vaccinium myrtilloides solution 
GINGER- zingiber officinale solution 
WHITE SEEDLESS GRAPE- vitis vinifera solution 
TOMATO- solanum lycopersicum solution 
GARLIC- allium sativum solution 
SOYBEAN FOOD- glycine max solution 
SPINACH- spinacia oleracea solution 
GREEN PEPPER- piper nigrum solution 
PINEAPPLE- ananas comosus solution 
STRAWBERRY- fragaria x ananassa solution 
YELLOW SUMMER SQUASH- cucurbita pepo var. ovifera solution 
BRAZIL NUT- bertholletia excelsa solution 
CRANBERRY- vaccinium macrocarpon solution 
GREEN OLIVE- olea europaea solution 
CHERRY- prunus avium solution 
LIMA BEAN- phaseolus lunatus solution 
HOPS FOOD- humulus lupulus solution 
NUTMEG- myristica fragrans solution 
PECAN FOOD- carya illinoinensis solution 
SWEET POTATO- ipomoea batatas solution 
WHITE POTATO- solanum tuberosum solution 
RED RASPBERRY- rubus idaeus solution 
ORANGE- citrus x sinensis solution 
BLACK WALNUT FOOD- juglans nigra solution 
WATERMELON- citrullus lanatus solution 
GRAPEFRUIT- citrus x paradisi solution 
PEACH- prunus persica solution 
PEANUT- arachis hypogaea solution 
GREEN ENGLISH PEA- pisum sativum solution 
PEAR- pyrus communis solution 
BEEF- bos taurus solution 
CHICKEN MEAT- gallus gallus solution 
CHICKEN EGG WHITE- gallus gallus solution 
CHICKEN EGG YOLK- gallus gallus solution 
CHICKEN EGG WHOLE- gallus gallus solution 
LAMB- ovis aries solution 
PORK- sus scrofa solution 
TURKEY MEAT- meleagris gallopavo solution 
COW MILK- bos taurus solution 
BLACK BASS- centropristis striata solution 
CATFISH- ictalurus punctatus solution 
CLAM- mercenaria mercenaria solution 
ATLANTIC COD- gadus morhua solution 
CRAB- callinectes sapidus solution 
FISH MIX- gadus morhua, paralichthys lethostigma, hippoglossus hippoglossus, scomber scombrus and thunnus albacares solution 
SHELLFISH MIX- mercenaria mercenaria, callinectes sapidus, crassostrea virginica, placopecten magellanicus and farfantepenaeus aztecus solution 
FLOUNDER- paralichthys lethostigma solution 
MAINE LOBSTER- homarus americanus solution 
MACKEREL- scomber scombrus solution 
OYSTER- crassostrea virginica solution 
OCEAN PERCH- sebastes alutus solution 
SALMON- salmo salar solution 
SCALLOPS- placopecten magellanicus solution 
SHRIMP- farfantepenaeus aztecus solution 
LAKE TROUT- oncorhynchus mykiss solution 
TUNA- thunnus albacares solution 
ALMOND FOOD- prunus dulcis solution 
APPLE- malus pumila solution 
ENGLISH WALNUT- juglans regia solution 
Greer Laboratories, Inc.

----------

Non Standardized Allergenic Extracts
Pollens, Molds, Epidermals, Insects, Dusts, Foods, and Miscellaneous Inhalants

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Non-Standardized Allergenic Extracts (Pollens, Molds, Epidermals, Insects, Foods and Miscellaneous Inhalants) safely and effectively. See full prescribing information for Non-Standardized Allergenic Extracts.

Non-Standardized Allergenic Extracts (Pollens, Molds, Epidermals, Insects, Foods, and Miscellaneous Inhalants)

Solutions for percutaneous, intradermal or subcutaneous administration.

Initial U.S. Approval: 1968

WARNING: SEVERE ALLERGIC REACTIONS

See full prescribing information for complete boxed warning.

  • Non-Standardized Allergenic Extracts can cause severe life-threatening systemic reactions, including anaphylaxis. (5.1)
  • Do not administer these products to patients with severe, unstable or uncontrolled asthma. (4)
  • Observe patients in the office for at least 30 minutes following treatment.Emergency measures and personnel trained in their use must be available immediately in the event of a life-threatening reaction. (5.1)
  • Patients with extreme sensitivity to these products, on an accelerated immunotherapy build-up, switching to another lot, receiving high doses of these products, and patients exposed to similar allergens may be at increased risk of a severe allergic reaction. (5.1)
  • These products may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a systemic allergic reaction, and for patients receiving medications such as beta-blockers that may make them unresponsive to epinephrine or inhaled bronchodilators. (5.1, 5.2)

INDICATIONS AND USAGE

Non-Standardized Allergenic Extracts are indicated for:

Food extracts have not been proven safe or effective in allergen immunotherapy.

DOSAGE AND ADMINISTRATION

For percutaneous, intradermal or subcutaneous use only.

The extracts are diluted with sterile diluents when used for intradermal testing or subcutaneous immunotherapy. For percutaneous testing, the extracts are diluted with sterile diluents in patients expected to be at greater risk for systemic allergic reaction. Dosages vary by mode of administration and by individual response. See full prescribing information for instructions on preparation, administration, and adjustments of dose. (2.1)

DOSAGE FORMS AND STRENGTHS

Non-Standardized Allergenic Extracts are labeled in weight/volume and/or protein nitrogen units (PNU)/milliliter (a measure of total protein), and are supplied as sterile aqueous stock concentrates at up to 1:10 weight/volume or 40,000 PNU/milliliter, or 50% glycerin stock concentrates at up to 1:20 weight/volume. (3)

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Severe allergic reactions have occurred following the administration of other allergenic extracts and may occur in individuals following the administration of Non-Standardized Allergenic Extracts in the following situations:

ADVERSE REACTIONS

The most common adverse reactions, occurring in 26 to 82% of all patients who receive subcutaneous immunotherapy, are local adverse reactions at the injection site (e.g., erythema, itching, swelling, tenderness, pain). (6)

Systemic adverse reactions, occurring in ≤ 7% of patients who receive subcutaneous immunotherapy, include generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension.

These can be fatal. (6)

To report SUSPECTED ADVERSE REACTIONS, contact GREER Laboratories, Inc. at 1-855-274-1322 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

See 17 for PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SEVERE ALLERGIC REACTIONS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration
2.2 Diagnostic Testing
2.3 Immunotherapy
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS

5.1 Serious Systemic Adverse Reactions
5.2 Epinephrine
5.3 Cross-Reactions and Dose Sensitivity
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS

7.1 Antihistamines
7.2 Topical Corticosteroids and Topical Anesthetics
7.3 Tricyclic Antidepressants
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the Full Prescribing Information are not listed.

FULL PRESCRIBING INFORMATION

WARNING: SEVERE ALLERGIC REACTIONS

1 INDICATIONS AND USAGE

Non-Standardized Allergenic Extracts are indicated for:

Food extracts have not been proven safe or effective in allergen immunotherapy.

2 DOSAGE AND ADMINISTRATION

For percutaneous, intradermal or subcutaneous use only.

The extracts are diluted with sterile diluents when used for intradermal testing or subcutaneous immunotherapy. For percutaneous testing, the extracts are diluted with sterile diluents in patients expected to be at greater risk for systemic allergic reaction. Dosages vary by mode of administration and by individual response.

2.1 Preparation for Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard solution if either of these conditions exist.

The extracts are diluted with sterile diluents when used for percutaneous and intradermal testing, or for subcutaneous immunotherapy.

Extracts labeled “For Diagnostic Use Only” are intended for percutaneous and intradermal testing only. These extracts have not been shown by adequate data to be safe and effective for therapeutic use. The extracts labeled For Diagnostic Use Only are the foods Barley, Coffee, Oat, Pineapple, Rye, Spinach, Wheat, the insects Flea, House Fly, Mosquito, and the plant and plant parts Cottonseed and Flax.

Undiluted 50% glycerin stock concentrate is used for percutaneous testing. To prepare 10-fold dilutions for percutaneous testing in patients suspected to be at greater risk for systemic allergic reaction, start with the stock concentrate. Proceed as shown in Table 1. The 10-fold dilution series uses 0.5 milliliters of concentrate added to 4.5 milliliters of sterile 50% glycerin diluent. Subsequent dilutions are made in a similar manner.

To prepare 10-fold dilutions for intradermal testing and immunotherapy, start with a 1:10 weight/volume, 1:20 weight/volume, or up to a 40,000 PNU/milliliter stock concentrate. Proceed as shown in Table 1. The 10-fold dilution series uses 0.5 milliliter of concentrate added to 4.5 milliliters of sterile diluent (glycerin-free diluents for intradermal testing, glycerin-free or 10% glycerin-saline diluents for immunotherapy). Subsequent dilutions are made in a similar manner.

Table 1: 10-fold Dilition Series*
Dilution ExtractMilliliters of DiluentDilution Strength (w/v)Dilution Strength (w/v)Dilution Strength (PNU/milliliter)
0Concentrate1:101:2020,000
10.5 mL Concentrate4.51:1001:2002,000
20.5 mL Dilution 14.51:1,0001:2,000200
30.5 mL Dilution 24.51:10,0001:20,00020
40.5 mL Dilution 34.51:100,0001:200,0002
50.5 mL Dilution 44.51:1,000,0001:2,000,0000.2
60.5 mL Dilution 54.51:10,000,0001:20,000,0000.02

*There is no direct potency correlation across the table between PNU/milliliter and w/v.

Undiluted 50% glycerin stock concentrate is used for percutaneous testing. To prepare 5-fold dilutions for percutaneous testing in patients suspected to be at greater risk for systemic allergic reaction, start with the stock concentrate. Proceed as shown in Table 2. The 5-fold dilution series uses 1 milliliter of concentrate added to 4 milliliters of sterile 50% glycerin diluent. Subsequent dilutions are made in a similar manner.

To prepare 5-fold dilutions for intradermal testing or immunotherapy, start with a 1:10 weight/volume, 1:20 weight/volume, or up to a 40,000 PNU/milliliter stock concentrate. Proceed as shown in Table 2. The 5-fold dilution series uses 1 milliliter of concentrate added to 4 milliliters of sterile diluent (glycerin-free diluents for intradermal testing, glycerin-free or 10% glycerin-saline diluents for immunotherapy). Subsequent dilutions are made in a similar manner.

Table 2: 5-fold Dilution Series*
DilutionExtractMilliliters of DiluentDilution Strength (w/v)Dilution Strength (w/v)Dilution Strength (PNU/milliliter)
0Concentrate1:101:2020,000
11 mL Concentrate41:501:1004,000
21 mL Dilution 141:2501:500800
31 mL Dilution 241:1,2501:2,500160
41 mL Dilution 341:6,2501:12,50032
51 mL Dilution 441:31,2501:62,5006.4
61 mL Dilution 541:156,2501:312,5001.28

*There is no direct potency correlation across the table between PNU/milliliter and w/v.

2.2 Diagnostic Testing

Diagnostic testing can be performed via percutaneous or intradermal administration of the Non-Standardized Allergenic Extracts. A positive skin test reaction should be interpreted in relation to the patient’s history and known exposure to the specific allergen(s).

Percutaneous Skin Testing

Preparation and Dose

For percutaneous testing (prick or puncture), use glycerinated extract; use the extracts at the highest available stock concentration. In patients suspected to be at greater risk for systemic allergic reaction, use 10-fold or 5-fold dilutions of the concentrate.

Prick test: Place one drop of extract with appropriate controls on the skin and with a skin test device, pierce through the drop into the skin with a slight lifting motion. Alternatively, use skin test devices loaded with the extract from the storage trays in a similar manner or in accordance with the device manufacturer’s recommendations.

Puncture test: Place one drop of extract or control on the skin and pierce the skin through the drop with a skin test device perpendicular to the skin. Alternatively, use skin test devices loaded with the extract from the storage trays in a similar manner or in accordance with the device manufacturer’s recommendations.

Interpreting Results

When using percutaneous skin test devices, follow the directions provided with the test devices. A glycerinated histamine control solution (6 milligrams/milliliter or 1 milligram/milliliter histamine base) may be used as the positive control. A 50% glycerin-saline solution may be used as the negative control.

Read and record skin test responses 15 to 20 minutes after exposure. Individual patient reactivity can vary with time, allergen potency, and/or immunotherapy, as well as testing technique. The most reliable method of recording a skin test reaction is to measure the largest diameter of both wheal and erythema. While some correlation exists between the size of the skin test reaction and the degree of sensitivity, other factors should be considered in the diagnosis of allergy to specific allergens (see Figure 1 below).

Figure 1: Measurement of Wheal and Flare

Use a paper or plastic millimeter skin reaction guide as shown below.

Figure_1

Fifteen minutes after application of the skin test, measure the length and midpoint orthogonal width of each flare and wheal from the inner edge of the reaction.

Length_and_Midpoint_Orthogonal_Width

The length of the skin test is defined as the largest diameter and the width of the skin test is defined as the diameter perpendicular to the length at its midpoint. Consider the wheal and flare as separate entities. First, measure the flare and then independently measure the wheal.

Measuring the Flare

Measure_the_Flare

Measuring the Wheal

Measuring_the_Wheal

The average diameter measurement in the example above of the flare is (26 mm + 36 mm)/2 = 31 mm and the average diameter of the wheal is (10 mm + 16 mm)/2 = 13 mm.

Responses to positive controls should be at least 3 millimeters larger than responses to the negative controls.

Negative controls should elicit no reaction or only reactions of small diameter (less than 2 millimeters wheal, less than 5 millimeters erythema).

If either the positive or negative control response does not meet the above criteria, results for the allergenic extracts tested at the same time should be considered invalid and be repeated.

Intradermal Skin Testing

Preparation and Dose

For intradermal testing, dilute stock concentrate to 1:100 to 1:1000 volume to volume of Non-Standardized Allergenic Extracts stock concentrate solution. Dilute the stock concentrate solution with sterile diluent [see Dosage and Administration (2.1)]. Use normal or buffered saline or normal saline with human serum albumin (HSA) diluent. If the result from the initial test dose is negative, subsequent intradermal tests using increasingly stronger doses may be performed up to the maximum recommended strength of 1:25 volume to volume dilution of the extract concentrate solution.

Inject 0.02 milliliters of the extract solution intradermally according to the algorithms shown in Figure 2.

Figure 2: Algorithm for Dilution of Stock Concentrate Solution of Non-Standardized Allergenic Extracts for Intradermal Skin Testing

Figure_2

1 Corresponds to 1:10,000 - 1:15,625 volume to volume dilution of 1:20 weight/volume glycerinated extract concentrates

2 Corresponds to 1:100 - 1:125 volume to volume dilution of 1:20 weight/volume glycerinated extract concentrates

3 Corresponds to 1:50 - 1:100 volume to volume dilution of 1:20 weight/volume glycerinated extract concentrates

4 Corresponds to 1:25 - 1:100 volume to volume dilution of 1:20 weight/volume glycerinated extract concentrates

2.3 Immunotherapy

For subcutaneous administration only.

Preparation and Dose

Stock concentrates of Non-Standardized Allergenic Extracts are available in aqueous (up to 1:10 weight/volume or 40,000 PNU/milliliter) and 50% glycerin (up to 1:20 weight/volume) strengths for immunotherapy. Stock concentrates are diluted in normal saline, buffered saline, HSA-saline, or 10% glycerin-saline, depending on the patient’s reactivity to the diluent. See Table 1 and Table 2 for dilution preparation.

Administration of Immunotherapy

Administer immunotherapy by subcutaneous injection in the lateral aspect of the upper arm or thigh. Avoid injection directly into any blood vessel.

The optimal interval between doses of allergenic extract varies among individuals. Injections are usually given 1 to 2 times per week until the maintenance dose is reached, at which time the injection interval is increased to 2, then 3, and finally 4 weeks. Dosages vary by mode of administration, and by clinical response and tolerance. The minimum course of treatment may be three to five years, depending on the clinical response.

Guidelines for Immunotherapy

The initial dose of the extract should be based on the skin test reactivity. In patients suspected to be at greater risk for systemic allergic reaction by history and skin test, the initial dose of the extract should be 0.05 milliliter of a 1:20,000,000 to 1:2,000,000 weight/volume extract dilution. Patients not suspected to be at greater risk for systemic allergic reaction may be started at 0.1 milliliter of a 1:200,000 to 1:20,000 weight/volume extract dilution.

The dose of allergenic extract is increased at each injection by no more than 50% of the previous dose, and the next increment is governed by the response to the last injection.

Select the maximum tolerated maintenance dose based on the patient’s clinical response and tolerance. Doses larger than 0.2 milliliter of the stock concentrate are rarely administered because an extract in 50% glycerin diluent can cause discomfort upon injection.

Dosage Modification Guidelines for Immunotherapy

The following conditions may indicate a need to withhold or reduce the dosage of immunotherapy.

Any evidence of a systemic reaction is an indication for a significant reduction (at least 75%) in the subsequent dose. Repeated systemic adverse reactions are sufficient reason for the cessation of further attempts to increase the dose.

Local adverse reactions require a decrease in the next dose by at least 50%. Proceed cautiously in subsequent dosing. In situations prompting dose reduction, once the reduced dose is tolerated, a cautious increase in dosage can be attempted.

Changing extract to a different lot or from a different manufacturer: When switching to a different lot of extract, or from another manufacturer’s extract, decrease the starting dose. Because manufacturing processes and sources of raw materials differ among manufacturers, the interchangeability of extracts from different manufacturers cannot be assured. In general, a dose reduction of 50 to 75% of the previous dose should be adequate, but each situation must be evaluated separately, considering the patient’s history of sensitivity, tolerance of previous injections, and other factors. Dose intervals should not exceed one week when rebuilding the dose.

Unscheduled gaps between treatments: Patients can lose tolerance to allergen injections during prolonged periods between doses, which increases their risk for an adverse reaction. The duration of tolerance between injections varies from patient to patient.

During the build-up phase, when patients receive injections 1 to 2 times per week, repeat or reduce the extract dosage if there

has been a substantial time interval between injections. This depends on: 1) the concentration of allergen immunotherapy extract that is to be administered; 2) a previous history of systemic reactions; and 3) the degree of variation from the prescribed interval of time, with longer intervals since the last injection leading to greater reductions in the dose to be administered.

This suggested approach to dose modification, due to unscheduled gaps between treatments during the build-up phase, is not based on published evidence. The individual physician should use this or a similar protocol for the specific clinical setting.

Similarly, if unscheduled gaps occur during maintenance therapy, it may be necessary to reduce the dosage and bring the patient up to maintenance dosing using an established build-up protocol.

Changing from non-stabilized to human serum albumin (HSA) stabilized diluents: Allergenic extracts prepared with diluents containing HSA and 0.4% phenol are more stable than those prepared with diluents that do not contain stabilizers. When switching from a non-stabilized to an HSA-stabilized diluent, consider lowering the dose for immunotherapy.

3 DOSAGE FORMS AND STRENGTHS

Non-Standardized Allergenic Extracts are labeled in weight/volume and/or protein nitrogen units (PNU)/milliliter (a measure of total protein), and are supplied as sterile aqueous stock concentrates at up to 1:10 weight/volume or 40,000 PNU/milliliter, or 50% glycerin stock concentrates at up to 1:20 weight/volume.

4 CONTRAINDICATIONS

Non-Standardized Allergenic Extracts are contraindicated in patients with:

5 WARNINGS AND PRECAUTIONS

5.1 Serious Systemic Adverse Reactions

Serious systemic adverse reactions have occurred following the administration of other allergenic extracts and may occur in individuals following the administration of Non-Standardized Allergenic Extracts in the following situations:

High-risk patients have had fatal reactions. Consider using more dilute preparations in patients suspected to be at greater risk of systemic allergic reaction [see Dosage and Administration (2.1)].

Administer Non-Standardized Allergenic Extracts in a healthcare setting under the supervision of a physician prepared to manage a severe systemic or a severe local allergic reaction.Observe patients in the office for at least 30 minutes following administration. 1

5.2 Epinephrine

Non-Standardized Allergenic Extracts may not be suitable for patients with certain medical conditions that may reduce the ability to survive a serious allergic reaction or increase the risk of adverse reactions after epinephrine administration. Examples of these medical conditions include but are not limited to: markedly compromised lung function (either chronic or acute), unstable angina, recent myocardial infarction, significant arrhythmia, and uncontrolled hypertension.

These products may not be suitable for patients who are taking medications that can potentiate or inhibit the effect of epinephrine. These medications include:

Βeta-adrenergic blockers: Patients taking beta-adrenergic blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Specifically, beta-adrenergic blockers antagonize the cardiostimulating and bronchodilating effects of epinephrine.

Alpha-adrenergic blockers, ergot alkaloids: Patients taking alpha-adrenergic blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Specifically, alpha-adrenergic blockers antagonize the vasoconstricting and hypertensive effects of epinephrine. Similarly, ergot alkaloids may reverse the pressor effects of epinephrine.

Tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and certain antihistamines: The adverse effects of epinephrine may be potentiated in patients taking tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and the antihistamines chlorpheniramine, and diphenhydramine.

Cardiac glycosides, diuretics: Patients who receive epinephrine while taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias.

5.3 Cross-Reactions and Dose Sensitivity

When determining the final dose of an allergen mixture for immunotherapy, consider cross-reactivity among component extracts.

Determine the initial dilution of allergenic extract, starting dose, and progression of dosage based on the patient’s history and results of skin tests 2 [see Dosage and Administration (2.1)]. Strongly positive skin tests can be indicators for potential adverse reactions.

6 ADVERSE REACTIONS

The most common adverse reactions, occurring in 26 to 82% of all patients who receive subcutaneous immunotherapy are local adverse reactions at the injection site (e.g., erythema, itching, swelling, tenderness, pain). 1 Systemic adverse reactions, occurring in ≤ 7% of patients who receive subcutaneous immunotherapy, 3 include generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. These adverse reactions can be fatal. 1

The allergenic extracts labeled “For Diagnostic Use Only” that contain sodium formaldehyde sulfoxylate (SFS) can cause slight discoloration of the skin at the site of administration. This discoloration can remain for extended amounts of time.

7 DRUG INTERACTIONS

7.1 Antihistamines

Do not perform skin testing with allergenic extracts within 3 to 10 days of use of first-generation H1-histamine receptor blockers (e.g., clemastine, diphenhydramine) and second-generation antihistamines (e.g., loratadine, cetirizine). These products suppress histamine skin test reactions and could mask a positive response. 2

7.2 Topical Corticosteroids and Topical Anesthetics

Topical corticosteroids can suppress skin reactivity; therefore, discontinue use at the skin test site for 2 to 3 weeks before skin testing. Avoid use of topical local anesthetics at skin test sites as they can suppress flare responses. 2

7.3 Tricyclic Antidepressants

Tricyclic antidepressants can have potent antihistamine effects that can affect skin testing. If tricyclic medication has been recently discontinued, allow 7 to 14 days before initiating skin testing. 2

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There are no human or animal data to establish the presence or absence of Non-Standardized Allergenic Extracts-associated risks during pregnancy.

8.2 Lactation

Risk Summary

It is not known whether Non-Standardized Allergenic Extracts are present in human milk. Data are not available to assess the effects of these extracts on the breastfed child or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Non-Standardized Allergenic Extracts and any potential adverse effects on the breastfed child from the extracts or from the underlying maternal condition.

8.4 Pediatric Use

For use of these products in children younger than 5 years of age, consideration should be given to the patient’s ability to comply and cooperate with allergen immunotherapy and the potential for difficulty in communicating with the child regarding systemic reactions. 1

8.5 Geriatric Use

Data are not available to determine if subjects 65 years of age and older respond differently to allergen immunotherapy than younger subjects.

11 DESCRIPTION

Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9.

Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant.

Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures.

Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter.

Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The skin test reaction results from interaction of the introduced allergen and allergen-specific IgE antibodies bound to mast cells, leading to mast cell degranulation and release of histamine, tryptase and other mediators, which results in the formation of the wheal and flare.

The precise mechanisms of action of allergen immunotherapy are not known. Immunologic responses to immunotherapy include changes in allergen-specific IgE levels, allergen-specific IgG levels, and regulatory T cell responses. 1

14 CLINICAL STUDIES

Specific immunotherapy with allergenic extracts is helpful in reducing symptoms associated with exposure to the offending allergens. A summary of effectiveness by the Panel on Review of Allergenic Extracts, an advisory committee to the U.S. Food and Drug Administration, has been published. 4

15 REFERENCES

  1. Cox LJ, Nelson H, Lockey R.Allergen immunotherapy: A practice parameter third update. J Allergy Clin Immunol. 2011;127:(1)S1-55.
  2. Bernstein IL, Li JT, Bernstein DI, et al.Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008;100:S1-148.
  3. Greenberg MA, Kaufman CR, Gonzalez GE, et al. Late and immediate systemic-allergic reactions to inhalant allergen immunotherapy. J Allergy Clin Immunol. 1986;77:865-870.
  4. Federal Register Proposed Rule: Biological Products: Implementation of Efficacy Review, Allergenic Extracts, Federal Register 1985;50: 3082-3288.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Non-Standardized Allergenic Extracts and mixes may be supplied as aqueous stock concentrates of up to 1:10 weight/volume or 40,000 PNU/milliliter for intradermal and subcutaneous testing. The extracts may also be supplied as 50% glycerin stock concentrates of up to 1:20 weight/volume for use in percutaneous skin testing and subcutaneous immunotherapy. Non-Standardized Allergenic Extracts are labeled in weight/volume and/or PNU/milliliter and may be provided in 5, 10, and 50 milliliter vials. Glycerinated extracts are also supplied in 5 milliliter dropper vials for prick or puncture testing.

Non-Standardized Allergenic Extracts available are as follows:

Pollens ‑ Grasses
Bahia Grass, Paspalum notatum
Brome, Smooth, Bromus inermis
Canarygrass, Reed, Phalaris arundinacea
Johnson Grass, Sorghum halepense
Quack (Couch) Grass, Elymus repens
Ryegrass, Giant Wild, Leymus condensatus
Velvetgrass, Holcus lanatus
Wheatgrass, Western, Pascopyrum smithii
Pollens - Trees
Acacia, Acacia dealbata
Alder, Hazel, Alnus serrulata
Alder, Red, Alnus rubra
Alder, White, Alnus rhombifolia
Ash, Arizona (Velvet), Fraxinus velutina
Ash, Green, Fraxinus pennsylvanica
Ash Mix (Equal parts Fraxinus pennsylvanica, Fraxinus americana)
Ash, Oregon, Fraxinus latifolia
Ash, White, Fraxinus americana
Aspen, Populus tremuloides
Beech, American, Fagus grandifolia
Birch, Black-Sweet, Betula lenta
Birch, Mix (Equal parts Betula lenta, Betula nigra, Betula populifolia)
Birch, River, Betula nigra
Birch, Spring, Betula occidentalis
Birch, White, Betula populifolia
Box Elder, Acer negundo
Cedar, Mountain, Juniperus ashei
Cedar, Red, Juniperus virginiana
Cedar, Salt (Tamarisk), Tamarix gallica
Central/Eastern 4 Tree Mix (Equal parts Ulmus americana, Acer negundo, Carya illinoinensis, Quercus virginiana)
Cottonwood, Arizona (Fremont), Populus fremontii
Cottonwood, Black, Populus trichocarpa
Cottonwood, Eastern, Populus deltoides
Cottonwood, Western, Populus deltoides ssp. monilifera
Cypress, Arizona, Callitropsis arizonica
Cypress, Bald, Taxodium distichum
Eastern Oak Mix (Equal parts Quercus velutina, Quercus rubra, Quercus alba)
Eastern 6 Tree Mix (Equal parts Fagus grandifolia, Populus deltoides, Quercus rubra, Betula nigra, Carya ovata, Fraxinus americana)
Eastern 7 Tree Mix (Equal parts Ulmus americana, Fagus grandifolia, Populus deltoides, Quercus rubra, Betula nigra, Carya ovata, Fraxinus americana)
Eastern 8 Tree Mix (Equal parts Ulmus americana, Fagus grandifolia, Populus deltoides, Quercus rubra, Betula nigra, Carya ovata, Fraxinus americana, Acer saccharum)
Eastern 10 Tree Mix (Equal parts Platanus occidentalis, Ulmus americana, Fagus grandifolia, Populus deltoides, Quercus rubra, Betula nigra, Carya ovata, Fraxinus americana, Acer saccharum, Liquidambar styraciflua)
Elm, American, Ulmus americana
Elm, Cedar, Ulmus crassifolia
Elm Mix (Equal parts Ulmus americana, Ulmus pumila)
Elm, Siberian, Ulmus pumila
Eucalyptus, Bluegum, Eucalyptus globulus
Hackberry, Celtis occidentalis
Hazelnut, American, Corylus americana
Hickory Mix (Equal parts Carya glabra, Carya ovata, Carya laciniosa, Carya tomentosa)
Hickory-Pecan Mix (Equal parts Carya illinoinensis, Carya ovata)
Hickory, Shagbark, Carya ovata
Hickory, Shellbark, Carya laciniosa
Hickory, White, Carya tomentosa
Juniper Mix (Equal parts Juniperus monosperma, Juniperus scopulorum)
Juniper, Oneseed, Juniperus monosperma
Juniper, Pinchot, Juniperus pinchotii
Juniper, Rocky Mountain, Juniperus scopulorum
Juniper, Utah, Juniperus osteosperma
Juniper, Western, Juniperus occidentalis
Locust Blossom, Black, Robinia pseudoacacia
Mango Blossom, Mangifera indica
Maple-Box Elder Mix (Equal parts Acer saccharum, Acer negundo)
2 Maple Mix (Equal parts Acer rubrum, Acer saccharum)
3 Maple Mix (Equal parts Acer rubrum, Acer saccharinum, Acer saccharum)
Maple, Red, Acer rubrum
Maple, Silver/Soft, Acer saccharinum
Maple, Sugar/Hard, Acer saccharum
Melaleuca, Melaleuca quinquenervia
Mesquite, Velvet Prosopis velutina
Mulberry, Paper, Broussonetia papyrifera
Mulberry, Red, Morus rubra
Mulberry, White, Morus alba
Oak, Arizona (Gambel), Quercus gambelii
Oak, Black, Quercus velutina
Oak, Bur, Quercus macrocarpa
Oak, California Black, Quercus kelloggii
Oak, California Live, Quercus agrifolia
Oak, California White, Quercus lobata
Oak, Post, Quercus stellata
Oak, Red, Quercus rubra
Oak, Virginia Live, Quercus virginiana
Oak, Water, Quercus nigra
Oak, Western White, Quercus garryana
Oak, White, Quercus alba
Olive, Olea europaea
Olive, Russian, Elaeagnus angustifolia
Orange Pollen, Citrus X sinensis
Palm, Queen, Syagrus romanzoffiana
Pecan, Carya illinoinensis
Peppertree Mix (Equal parts Schinus molle, Schinus terebinthifolius)
Pine, Australian (Beefwood), Casuarina equisetifolia
Pine, Loblolly, Pinus taeda
Pine, Longleaf, Pinus palustris
Pine Mix (Equal parts Pinus taeda, Pinus strobus, Pinus echinata)
Pine, Ponderosa, Pinus ponderosa
Pine, Virginia Scrub, Pinus virginiana
Pine, White (Eastern), Pinus strobus
Pine, White (Western), Pinus monticola
Pine, Yellow, Pinus echinata
Poplar, Lombardy’s, Populus nigra
Poplar, White, Populus alba
Privet, Ligustrum vulgare
Sweetgum, Liquidambar styraciflua
Sycamore, American, Platanus occidentalis
Sycamore, California (Western), Platanus racemosa
11 Tree Mix (Equal parts Fagus grandifolia, Platanus occidentalis, Ulmus americana, Juglans nigra, Salix nigra, Populus deltoides,Quercus rubra, Betula nigra, Carya ovata, Acer saccharum, Fraxinus americana)
Walnut, Black, Juglans nigra
Walnut, California Black, Juglans californica
Walnut, English, Juglans regia
Wax Myrtle, Morella cerifera
Western Oak Mix (Equal parts Quercus kelloggii, Quercus agrifolia, Quercus garryana)
Western 3 Tree Mix (Equal parts Olea europaea, Ulmus pumila, Platanus racemosa)
Western 10 Tree Mix (Equal parts Acacia dealbata, Acer negundo, Populus fremontii, Olea europaea, Ulmus pumila, Betula occidentalis, Juniperus occidentalis, Platanus racemosa, Quercus garryana, Morus alba)
Western Walnut Mix (Equal parts Juglans californica, Juglans regia)
Willow, Arroyo, Salix lasiolepis
Willow, Black, Salix nigra
Pollens - Weeds and Garden Plants
Allscale, Atriplex polycarpa
Amaranth, Green, Amaranthus hybridus
Baccharis Mix (Equal parts Baccharis sarothroides, Baccharis halimifolia)
Burningbush (Kochia), Kochia scoparia spp. scoparia
Burrobrush, Ambrosia salsola
Central/Western Weed Mix (Equal parts Kochia scoparia ssp. scoparia, Chenopodium album, Salsola kali)
Cocklebur, Xanthium strumarium
Common Weed Mix (Equal parts Xanthium strumarium, Plantago lanceolata, Chenopodium album, Amaranthus retroflexus, Salsola kali)
Dock-Sorrel Mix (Equal parts Rumex acetosella, Rumex crispus)
Dock, Yellow (Curly), Rumex crispus
Dogfennel, Eupatorium capillifolium
Goldenrod, Solidago canadensis
Iodinebush, Allenrolfea occidentalis
Lamb's Quarters, Chenopodium album
Lenscale (Quailbrush), Atriplex lentiformis
Marsh Elder, True (Rough), Iva annua
Marshelder, Burweed (Giant Poverty), Cyclachaena xanthiifolia
Mixed Amaranths (Equal parts Amaranthus hybridus, Amaranthus palmeri, Amaranthus retroflexus)
Mugwort, Common, Artemisia vulgaris
National Weed Mix (Equal parts Xanthium strumarium, Ambrosia trifida, Chenopodium album, Amaranthus retroflexus, Ambrosia artemisiifolia)
Nettle, Urtica dioica
Palmer's Amaranth, Amaranthus palmeri
Pigweed, Rough Redroot, Amaranthus retroflexus
Pigweed, Spiny, Amaranthus spinosus
Plantain, English, Plantago lanceolata
Plantain-Sorrel Mix (Equal parts Plantago lanceolata, Rumex acetosella)
Rabbit Bush, Ambrosia deltoidea
Ragweed, Desert, Ambrosia dumosa
Ragweed, False, Ambrosia acanthicarpa
Ragweed, Giant (Tall), Ambrosia trifida
Ragweed, Lanceleaf, Ambrosia bidentata
Ragweed, Slender, Ambrosia confertiflora
Ragweed, Western, Ambrosia psilostachya
Russian Thistle, Salsola kali
Sagebrush, Common, Artemisia tridentata
Sage Mix (Equal parts Artemisia tridentata, Artemisia ludoviciana)
Sage, Prairie, Artemisia ludoviciana
Saltbush, Annual, Atriplex wrightii
Scale/Atriplex Mix (Equal parts Atriplex polycarpa, Atriplex lentiformis, Atriplex canescens)
Sorrel, Sheep (Red), Rumex acetosella
Waterhemp, Tall, Amaranthus tuberculatus
3 Weed Mix (Equal parts Xanthium strumarium, Chenopodium album, Amaranthus retroflexus)
Western Ragweed Mix (Equal parts Ambrosia acanthicarpa, Ambrosia psilostachya)
Wingscale, Atriplex canescens
Plants and Plant Parts
Cotton Linters, Gossypium hirsutum
Cottonseed, Gossypium hirsutum (For Diagnostic Use Only)
Flax, Linum usitatissimum (For Diagnostic Use Only)
Gum, Arabic, Acacia senegal
Gum, Karaya, Sterculia urens
Gum, Tragacanth, Astragalus gummifer
Kapok, Ceiba pentandra
Orris Root, Iris germanica
Pyrethrum, Chrysanthemum cinerariifolium
Tobacco, Cultivated, Leaf, Nicotiana tabacum
Pollens - Cultivated Farm Plants
Alfalfa, Medicago sativa
Beet, Sugar, Beta vulgaris
Corn, Cultivated, Zea mays
Oat, Cultivated, Avena sativa
Rape (Mustard), Brassica napus
Red Clover, Trifolium pratense
Rye, Cultivated, Secale cereale
Wheat, Cultivated, Triticum aestivum
Pollens - Flowers
Daisy, Leucanthemum vulgare
Dandelion, Taraxacum officinale
Sunflower, Helianthus annuus
Molds, Rusts and Smuts
AHH Mold Mix (Equal parts Alternaria alternata, Bipolaris sorokiniana, Cladosporium sphaerospermum)
Alternaria alternata
Alternaria/Hormodendrum Mix (Equal parts Alternaria alternata, Cladosporium sphaerospermum)
Aspergillus amstelodami
Aspergillus flavus
Aspergillus fumigatus
Aspergillus Mix (Equal parts Aspergillus amstelodami, Aspergillus flavus, Aspergillus fumigatus, Aspergillus nidulans, Aspergillus niger)
Aspergillus nidulans
Aspergillus niger
Aureobasidium pullulans
Bermuda Grass Smut, Ustilago cynodontis
Bipolaris sorokiniana
Botrytis cinerea
Candida albicans
Chaetomium globosum
Cladosporium herbarum
Cladosporium sphaerospermum
Corn Smut, Ustilago maydis
Curvularia spicifera
Dematiaceae Mix (Equal parts Alternaria alternata, Aureobasidium pullulans, Bipolaris sorokiniana, Cladosporium herbarum, Curvularia spicifera, Helminthosporium solani)
Epicoccum nigrum
Epidermophyton floccosum
Fusarium Mix (Equal parts Gibberella fujikuroi, Fusarium solani)
Fusarium solani
Geotrichum candidum
Gibberella fujikuroi
Gliocladium viride
Grain Smut Mix (Equal parts Ustilago maydis, Ustilago tritici, Ustilago nuda, Ustilago avenae)
Grass Smut Mix (Equal parts Ustilago cynodontis, Sporisorium cruentum)
Helminthosporium solani
Hypomyces perniciousus
Loose Kernel Smut, Sporisorium cruentum
Loose Smut, Wheat, Ustilago tritici
Microsporum canis
Mold Mix #1 (Equal parts Alternaria alternata, Aspergillus niger, Bipolaris sorokiniana, Cladosporium sphaerospermum, Penicillium chrysogenum var. chrysogenum)
Mold Mix #2 (Equal parts Aureobasidium pullulans, Curvularia spicifera, Gibberella fujikuroi, Mucor plumbeus, Rhizopus stolonifer)
Mold Mix #3 (Equal parts Alternaria alternata, Aspergillus niger, Cladosporium sphaerospermum, Penicillium chrysogenum var. chrysogenum)
Monilia Mix (Equal parts Candida albicans, Neurospora intermedia)
Mucor circinelloides f. circinelloides
Mucor circinelloides f. lusitanicus
Mucor Mix (Equal parts Mucor circinelloides f. lusitanicus, Mucor plumbeus)
Mucor plumbeus
Neurospora intermedia
New Stock Fungi Mix (Equal parts Sarocladium strictum, Alternaria alternata, Aspergillus niger, Aureobasidium pullulans, Bipolaris sorokiniana, Botrytis cinerea, Candida albicans, Chaetomium globosum, Cladosporium sphaerospermum, Epicoccum nigrum, Gibberella fujikuroi, Mucor plumbeus, Penicillium chrysogenum var. chrysogenum, Phoma betae, Rhizopus stolonifer, Trichophyton mentagrophytes)
Oat Smut, Ustilago avenae
Paecilomyces variotii
Penicillium chrysogenum var. chrysogenum
Penicillium digitatum
Penicillium Mix (Equal parts Penicillium camemberti, Penicillium chrysogenum, Penicillium digitatum, Penicillium chrysogenum var. chrysogenum, Penicillium roqueforti)
Phoma betae
Phycomycetes Mix (Equal parts Mucor circinelloides f. lusitanicus, Rhizopus stolonifer)
Rhizopus arrhizus
Rhizopus Mix (Equal parts Rhizopus stolonifer, Rhizopus arrhizus)
Rhizopus stolonifer
Rhodotorula mucilaginosa
Saccharomyces cerevisiae
Sarocladium strictum
Stemphylium solani
Trichoderma harzianum
Trichophyton mentagrophytes
Trichophyton rubrum
Trichothecium roseum
Animal Allergens
Canary Feathers, Serinus canaria
Cattle Epithelia, Bos taurus
Chicken Feathers, Gallus gallus
Dog Epithelia, Canis lupus familiaris
Duck Feathers, Anas platyrhynchos
Gerbil Epithelia, Meriones unguiculatus
Goat Epithelia, Capra hircus
Goose Feathers, Anser anser
Guinea Pig Epithelia, Cavia porcellus
Hamster Epithelia, Mesocricetus auratus
Hog Epithelia, Sus scrofa
Horse Epithelia, Equus caballus
Mixed Feathers (Equal parts Gallus gallus, Anas platyrhynchos, Anser anser)
Mouse Epithelia, Mus musculus
Parakeet Feathers, Melopsittacus undulatus
Rabbit Epithelia, Oryctolagus cuniculus
Rat Epithelia, Rattus norvegicus
Silk Worm Cocoon, Bombyx mori
Insects (Whole Body)
Ant, Black Carpenter, Camponotus pennsylvanicus
Ant, Fire, Solenopsis invicta
Ant, Fire, Solenopsis richteri
Cockroach, American, Periplaneta americana
Cockroach, German, Blattella germanica
2 Cockroach Mix (Equal parts Periplaneta americana, Blattella germanica)
Deer Fly, Chrysops vittatus
Flea, Ctenocephalis felis (For Dagnostic Use Only)
House Fly, Musca domestica (For Dagnostic Use Only)
Mosquito, Aedes taeniorhynchus (For Diagnostic Use Only)
Food - Animal Products and Poultry Products
Beef, Bos taurus
Chicken Meat, Gallus gallus
Egg, White, Chicken, Gallus gallus
Egg, Whole, Chicken, Gallus gallus
Egg, Yolk, Chicken, Gallus gallus
Lamb, Ovis aries
Pork, Sus scrofa
Turkey Meat, Meleagris gallopavo
Food - Dairy Products
Milk, Cow, Bos taurus
Food - Fish and Shellfish
Bass, Black, Centropristis striata
Catfish, Channel, Ictalurus punctatus
Clam, Northern Quahog, Mercenaria mercenaria
Cod, Atlantic, Gadus morhua
Crab, Blue, Callinectes sapidus
Fish Mix (Equal parts Gadus morhua, Paralichthys lethostigma, Hippoglossus hippoglossus, Scomber scombrus, Thunnus albacares)
Flounder, Southern, Paralichthys lethostigma
Lobster, American, Homarus americanus
Mackerel, King/Atlantic, Scomber scombrus
Oyster, Atlantic/Eastern, Crassostrea virginica
Perch, Ocean, Sebastes alutus
Salmon, Atlantic, Salmo salar
Scallops, Sea, Placopecten magellanicus
Shellfish Mix (Equal parts Mercenaria mercenaria, Callinectes sapidus, Crassostrea virginica, Placopecten magellanicus, Farfantepenaeus aztecus)
Shrimp, Brown, Farfantepenaeus aztecus
Trout, Rainbow, Oncorhynchus mykiss
Tuna, Yellowfin, Thunnus albacares
Food - Plant Source
Almond, Prunus dulcis
Apple, Malus pumila
Apricot, Prunus armeniaca
Barley, Whole Grain, Hordeum vulgare (For Diagnostic Use Only, Contains SFS*)
Bean, Lima, Phaseolus lunatus
Bean, Navy, Phaseolus vulgaris
Bean, String Green, Phaseolus vulgaris
Blueberry, Velvetleaf, Vaccinium myrtilloides
Brazil Nut, Bertholletia excelsa
Broccoli, Brassica oleracea var. botrytis
Buckwheat, Fagopyrum esculentum
Cabbage, Brassica oleracea var. capitata
Cacao Bean, Theobroma cacao
Cantaloupe, Cucumis melo
Carrot, Daucus carota
Cashew Nut, Anacardium occidentale
Cauliflower, Brassica oleracea var. botrytis
Celery, Apium graveolens var. dulce
Cherry, Sweet, Prunus avium
Cinnamon, Cinnamomum verum
Coconut, Cocos nucifera
Coffee, Coffea arabica (For Diagnostic Use Only)
Corn, Zea mays
Cranberry, Vaccinium macrocarpon
Cucumber, Cucumis sativus
Garlic, Allium sativum
Ginger, Zingiber officinale
Grape, White Seedless, Vitis vinifera
Grapefruit, Citrus X paradisi
Hazelnut (Filbert), Corylus americana
Hops, Humulus lupulus
Lemon, Citrus X limon
Lettuce, Lactuca sativa
Malt (Barley), Hordeum vulgare
Mushroom, Agaricus campestris
Mustard Seed, Sinapis alba
Nutmeg, Myristica fragrans
Oat, Avena sativa (For Diagnostic Use Only, Contains SFS*)
Olive, Green, Olea europaea
Onion, Allium cepa
Orange, Citrus X sinensis
Pea, Green or English, Pisum sativum
Peach, Prunus persica
Peanut, Arachis hypogaea
Pear, Pyrus communis
Pecan, Carya illinoinensis
Pepper, Black, Piper nigrum
Pepper, Green, Capsicum annuum
Pineapple, Ananas comosus (For Diagnostic Use Only, Contains SFS*)
Potato, Sweet, Ipomoea batatas
Potato, White, Solanum tuberosum
Raspberry, Red, Rubus idaeus
Rice, Oryza sativa
Rye, Secale cereale (For Diagnostic Use Only, Contains SFS*)
Sesame Seed, Sesamum indicum
Soybean, Glycine max
Spinach, Spinacia oleracea (For Diagnostic Use Only, Contains SFS*)
Squash, Yellow Summer, Cucurbita pepo var. ovifera
Strawberry, Fragaria X ananassa
Tomato, Solanum lycopersicum
Vanilla, Vanilla planifolia
Walnut, Black, Juglans nigra
Walnut, English, Juglans regia
Watermelon, Citrullus lanatus
Wheat, Whole, Triticum aestivum (For Diagnostic Use Only, Contains SFS*)

*SFS – Sodium Formadehyde Sulfoxylate

16.2 Storage and Handling

Maintain at 2 to 8°C (36 to 46°F) during storage and use.

Dilutions of concentrated extracts that result in a glycerin content of less than 50% can reduce extract stability. Extract dilutions at 1:100 volume to volume should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known allergic patient.

17 PATIENT COUNSELING INFORMATION

Instruct patient to remain under observation in the office for 30 minutes or longer after an injection.

Caution patient that reactions can occur more than 30 minutes after skin testing or an injection.

Instruct patient to recognize the following symptoms as adverse reactions and to immediately return to the office or immediately seek other medical attention if any of these symptoms occur following skin testing or an injection:

Manufacturer:

U.S. License No. 308

Greer Laboratories, Inc.

Lenoir, NC 28645 U.S.A

5786-5_Peanut_20-wv

5765-2_Cow_Milk_20-wv

RICE FOOD 
oryza sativa solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5746
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROWN RICE (UNII: 659G217HPG) (BROWN RICE - UNII:659G217HPG) BROWN RICE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5746-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5746-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
RYE FOOD 
secale cereale solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5747
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RYE (UNII: 0R4AQI398X) (RYE - UNII:0R4AQI398X) RYE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5747-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5747-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
SESAME SEED 
sesamum indicum solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5748
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SESAME SEED (UNII: 7Y1255HVXR) (SESAME SEED - UNII:7Y1255HVXR) SESAME SEED0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5748-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5748-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
BROCCOLI 
brassica oleracea var. botrytis solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5708
Route of AdministrationSUBCUTANEOUS, PERCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROCCOLI (UNII: UOI4FT57BZ) (BROCCOLI - UNII:UOI4FT57BZ) BROCCOLI0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5708-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5708-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
BUCKWHEAT 
fagopyrum esculentum solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5709
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUCKWHEAT (UNII: N0Y68724R3) (BUCKWHEAT - UNII:N0Y68724R3) BUCKWHEAT0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5709-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5709-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CASHEW NUT 
anacardium occidentale solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5783
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANACARDIUM OCCIDENTALE FRUIT (UNII: 4A10JR4E7E) (ANACARDIUM OCCIDENTALE FRUIT - UNII:4A10JR4E7E) ANACARDIUM OCCIDENTALE FRUIT0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5783-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5783-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CAULIFLOWER 
brassica oleracea var. botrytis solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5713
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAULIFLOWER (UNII: 138LUT2DWV) (CAULIFLOWER - UNII:138LUT2DWV) CAULIFLOWER0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5713-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5713-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CHOCOLATE CACAO BEAN 
theobroma cacao solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5716
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J) (THEOBROMA CACAO WHOLE - UNII:EB048G1S9J) THEOBROMA CACAO WHOLE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5716-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5716-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CANTALOUPE MUSKMELON 
cucumis melo solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5711
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MUSKMELON (UNII: ZV095H5633) (MUSKMELON - UNII:ZV095H5633) MUSKMELON0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5711-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5711-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CARROT 
daucus carota solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5712
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARROT (UNII: L56Z1JK48B) (CARROT - UNII:L56Z1JK48B) CARROT0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5712-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5712-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CELERY 
apium graveolens var. dulce solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5714
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CELERY (UNII: 44IDY6DTKX) (CELERY - UNII:44IDY6DTKX) CELERY0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5714-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5714-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
LETTUCE 
lactuca sativa solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5728
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LACTUCA SATIVA WHOLE (UNII: C0K52765EZ) (LACTUCA SATIVA WHOLE - UNII:C0K52765EZ) LACTUCA SATIVA WHOLE0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5728-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5728-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
FILBERT HAZELNUT FOOD 
corylus americana solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5785
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMERICAN HAZELNUT (UNII: IUP4S55D8S) (AMERICAN HAZELNUT - UNII:IUP4S55D8S) AMERICAN HAZELNUT0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5785-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5785-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
VANILLA 
vanilla planifolia solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5754
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VANILLA (UNII: Q74T35078H) (VANILLA - UNII:Q74T35078H) VANILLA0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5754-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5754-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
WHOLE WHEAT 
triticum aestivum solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5756
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5756-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5756-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
APRICOT 
prunus armeniaca solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5701
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
APRICOT (UNII: 269CJD5GZ9) (APRICOT - UNII:269CJD5GZ9) APRICOT0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5701-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5701-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
WHOLE GRAIN BARLEY 
hordeum vulgare solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5703
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R) BARLEY0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5703-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5703-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
NAVY BEAN 
phaseolus vulgaris solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5705
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KIDNEY BEAN (UNII: M98C8416QO) (KIDNEY BEAN - UNII:M98C8416QO) KIDNEY BEAN0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5705-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5705-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
STRING GREEN BEAN 
phaseolus vulgaris solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5706
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRING BEAN (UNII: N9D69B2Q7Y) (STRING BEAN - UNII:N9D69B2Q7Y) STRING BEAN0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5706-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5706-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CABBAGE 
brassica oleracea var. capitata solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5710
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CABBAGE (UNII: GW0W1Y9I97) (CABBAGE - UNII:GW0W1Y9I97) CABBAGE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5710-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5710-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CINNAMON 
cinnamomum verum solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5717
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CINNAMON (UNII: 5S29HWU6QB) (CINNAMON - UNII:5S29HWU6QB) CINNAMON0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5717-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5717-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
COFFEE 
coffea arabica solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5718
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E) COFFEA ARABICA SEED, ROASTED0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5718-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5718-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
MUSHROOM 
agaricus campestris solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5730
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FIELD MUSHROOM (UNII: 19988ORO24) (FIELD MUSHROOM - UNII:19988ORO24) FIELD MUSHROOM0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5730-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5730-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
MUSTARD FOOD 
sinapis alba solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5731
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WHITE MUSTARD SEED (UNII: 25VR943RPP) (WHITE MUSTARD SEED - UNII:25VR943RPP) WHITE MUSTARD SEED0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5731-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5731-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
BANANA 
musa acuminata solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5702
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MUSA ACUMINATA FRUIT (UNII: T6ENY6RV6W) (MUSA ACUMINATA FRUIT - UNII:T6ENY6RV6W) MUSA ACUMINATA FRUIT0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5702-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5702-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
COCONUT 
cocos nucifera solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5784
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCONUT (UNII: 3RT3536DHY) (COCONUT - UNII:3RT3536DHY) COCONUT0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5784-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5784-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CORN FOOD 
zea mays solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5719
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CORN (UNII: 0N8672707O) (CORN - UNII:0N8672707O) CORN0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5719-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5719-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
MALT 
hordeum vulgare solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5729
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R) BARLEY0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5729-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5729-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
BLACK PEPPER 
piper nigrum solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5740
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BLACK PEPPER (UNII: KM66971LVF) (BLACK PEPPER - UNII:KM66971LVF) BLACK PEPPER0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5740-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5740-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
LEMON 
citrus x limon solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5727
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEMON (UNII: 24RS0A988O) (LEMON - UNII:24RS0A988O) LEMON0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5727-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5727-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
OAT FOOD 
avena sativa solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5733
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK) OAT0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5733-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5733-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
ONION 
allium cepa solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5735
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5735-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5735-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CUCUMBER 
cucumis sativus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5721
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CUCUMBER (UNII: YY7C30VXJT) (CUCUMBER - UNII:YY7C30VXJT) CUCUMBER0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5721-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5721-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
BLUEBERRY 
vaccinium myrtilloides solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5707
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VELVETLEAF HUCKLEBERRY (UNII: NXH9EU7QU9) (VELVETLEAF HUCKLEBERRY - UNII:NXH9EU7QU9) VELVETLEAF HUCKLEBERRY0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5707-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5707-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
GINGER 
zingiber officinale solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5723
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5723-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5723-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
WHITE SEEDLESS GRAPE 
vitis vinifera solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5724
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WINE GRAPE (UNII: 3GOV20705G) (WINE GRAPE - UNII:3GOV20705G) WINE GRAPE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5724-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5724-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
TOMATO 
solanum lycopersicum solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5753
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOMATO (UNII: Z4KHF2C175) (TOMATO - UNII:Z4KHF2C175) TOMATO0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5753-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5753-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
GARLIC 
allium sativum solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5722
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5722-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5722-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
SOYBEAN FOOD 
glycine max solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5749
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SOYBEAN (UNII: L7HT8F1ZOD) (SOYBEAN - UNII:L7HT8F1ZOD) SOYBEAN0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5749-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5749-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
SPINACH 
spinacia oleracea solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5750
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SPINACH (UNII: 6WO75C6WVB) (SPINACH - UNII:6WO75C6WVB) SPINACH0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5750-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5750-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
GREEN PEPPER 
piper nigrum solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5741
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GREEN BELL PEPPER (UNII: 4J4DOU3HEK) (GREEN BELL PEPPER - UNII:4J4DOU3HEK) GREEN BELL PEPPER0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5741-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5741-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
PINEAPPLE 
ananas comosus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5742
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PINEAPPLE (UNII: 2A88ZO081O) (PINEAPPLE - UNII:2A88ZO081O) PINEAPPLE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5742-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5742-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
STRAWBERRY 
fragaria x ananassa solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5752
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRAWBERRY (UNII: 4J2TY8Y81V) (STRAWBERRY - UNII:4J2TY8Y81V) STRAWBERRY0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5752-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5752-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
YELLOW SUMMER SQUASH 
cucurbita pepo var. ovifera solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5751
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CUCURBITA PEPO SUBSP. OVIFERA WHOLE (UNII: 2NS91NJI8N) (CUCURBITA PEPO SUBSP. OVIFERA WHOLE - UNII:2NS91NJI8N) CUCURBITA PEPO SUBSP. OVIFERA WHOLE0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5751-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5751-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
BRAZIL NUT 
bertholletia excelsa solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5782
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BERTHOLLETIA EXCELSA WHOLE (UNII: Z945IQ8X82) (BERTHOLLETIA EXCELSA WHOLE - UNII:Z945IQ8X82) BERTHOLLETIA EXCELSA WHOLE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5782-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5782-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CRANBERRY 
vaccinium macrocarpon solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5720
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CRANBERRY (UNII: 0MVO31Q3QS) (CRANBERRY - UNII:0MVO31Q3QS) CRANBERRY0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5720-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5720-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
GREEN OLIVE 
olea europaea solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5734
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GREEN OLIVE (UNII: 6HD2W46UEG) (GREEN OLIVE - UNII:6HD2W46UEG) GREEN OLIVE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5734-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5734-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CHERRY 
prunus avium solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5715
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SWEET CHERRY (UNII: 93T4562ZI3) (SWEET CHERRY - UNII:93T4562ZI3) SWEET CHERRY0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5715-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5715-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
LIMA BEAN 
phaseolus lunatus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5704
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIMA BEAN (UNII: 112YH1ZMX2) (LIMA BEAN - UNII:112YH1ZMX2) LIMA BEAN0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5704-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5704-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
HOPS FOOD 
humulus lupulus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5726
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5726-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5726-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
NUTMEG 
myristica fragrans solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5732
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71) (MYRISTICA FRAGRANS FRUIT - UNII:GOO22BTU71) MYRISTICA FRAGRANS FRUIT0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5732-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5732-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
PECAN FOOD 
carya illinoinensis solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5787
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PECAN (UNII: F14P91GB5F) (PECAN - UNII:F14P91GB5F) PECAN0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5787-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5787-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
SWEET POTATO 
ipomoea batatas solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5743
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SWEET POTATO (UNII: M9WGG9Z9GK) (SWEET POTATO - UNII:M9WGG9Z9GK) SWEET POTATO0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5743-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5743-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
WHITE POTATO 
solanum tuberosum solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5744
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTATO (UNII: CFE1S8DYWD) (POTATO - UNII:CFE1S8DYWD) POTATO0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5744-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5744-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
RED RASPBERRY 
rubus idaeus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5745
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RASPBERRY (UNII: 4N14V5R27W) (RASPBERRY - UNII:4N14V5R27W) RASPBERRY0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5745-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5745-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
ORANGE 
citrus x sinensis solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5736
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ORANGE (UNII: 5EVU04N5QU) (ORANGE - UNII:5EVU04N5QU) ORANGE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5736-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5736-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
BLACK WALNUT FOOD 
juglans nigra solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5788
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BLACK WALNUT (UNII: 02WM57RXZJ) (BLACK WALNUT - UNII:02WM57RXZJ) BLACK WALNUT0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5788-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5788-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
WATERMELON 
citrullus lanatus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5755
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATERMELON (UNII: 231473QB6R) (WATERMELON - UNII:231473QB6R) WATERMELON0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5755-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5755-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
GRAPEFRUIT 
citrus x paradisi solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5725
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GRAPEFRUIT (UNII: O82C39RR8C) (GRAPEFRUIT - UNII:O82C39RR8C) GRAPEFRUIT0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5725-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5725-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
PEACH 
prunus persica solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5738
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PEACH (UNII: 3OKE88I3QG) (PEACH - UNII:3OKE88I3QG) PEACH0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5738-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5738-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
PEANUT 
arachis hypogaea solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5786
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PEANUT (UNII: QE1QX6B99R) (PEANUT - UNII:QE1QX6B99R) PEANUT0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5786-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5786-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3NDC:22840-5786-450 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
GREEN ENGLISH PEA 
pisum sativum solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5737
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PISUM SATIVUM WHOLE (UNII: J21YE3W98E) (PISUM SATIVUM WHOLE - UNII:J21YE3W98E) PISUM SATIVUM WHOLE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5737-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5737-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
PEAR 
pyrus communis solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5739
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PEAR (UNII: 2ZN8DWC0YF) (PEAR - UNII:2ZN8DWC0YF) PEAR0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5739-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5739-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
BEEF 
bos taurus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5757
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BEEF (UNII: 4PIB2155QP) (BEEF - UNII:4PIB2155QP) BEEF0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5757-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5757-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CHICKEN MEAT 
gallus gallus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5760
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHICKEN (UNII: 0X8Q245Y7B) (CHICKEN - UNII:0X8Q245Y7B) CHICKEN0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5760-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5760-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CHICKEN EGG WHITE 
gallus gallus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5761
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EGG WHITE (UNII: 3E0I92Z2GR) (EGG WHITE - UNII:3E0I92Z2GR) EGG WHITE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5761-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5761-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CHICKEN EGG YOLK 
gallus gallus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5763
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EGG YOLK (UNII: 4IPS17B70T) (EGG YOLK - UNII:4IPS17B70T) EGG YOLK0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5763-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5763-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CHICKEN EGG WHOLE 
gallus gallus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5762
Route of AdministrationPERCUTANEOUS, INTRADERMAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EGG (UNII: 291P45F896) (EGG - UNII:291P45F896) EGG0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5762-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5762-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
LAMB 
ovis aries solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5758
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LAMB (UNII: FOF26T73HA) (LAMB - UNII:FOF26T73HA) LAMB0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5758-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5758-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
PORK 
sus scrofa solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5759
Route of AdministrationPERCUTANEOUS, INTRADERMAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PORK (UNII: O138UB266J) (PORK - UNII:O138UB266J) PORK0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5759-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5759-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
TURKEY MEAT 
meleagris gallopavo solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5764
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TURKEY (UNII: 8E9NT44R8I) (TURKEY - UNII:8E9NT44R8I) TURKEY0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5764-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5764-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
COW MILK 
bos taurus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5765
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5765-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5765-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
BLACK BASS 
centropristis striata solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5766
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BLACK SEA BASS (UNII: 0YJW8KYT51) (BLACK SEA BASS - UNII:0YJW8KYT51) BLACK SEA BASS0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5766-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5766-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CATFISH 
ictalurus punctatus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5767
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHANNEL CATFISH (UNII: FIX499R7DR) (CHANNEL CATFISH - UNII:FIX499R7DR) CHANNEL CATFISH0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5767-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5767-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CLAM 
mercenaria mercenaria solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5768
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NORTHERN QUAHOG (UNII: D6G49OV9IM) (NORTHERN QUAHOG - UNII:D6G49OV9IM) NORTHERN QUAHOG0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5768-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5768-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
ATLANTIC COD 
gadus morhua solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5769
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATLANTIC COD (UNII: RPX7J99EXW) (ATLANTIC COD - UNII:RPX7J99EXW) ATLANTIC COD0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5769-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5769-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
CRAB 
callinectes sapidus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5770
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BLUE CRAB (UNII: 8J18RFO4A8) (BLUE CRAB - UNII:8J18RFO4A8) BLUE CRAB0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5770-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5770-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
FISH MIX 
gadus morhua, paralichthys lethostigma, hippoglossus hippoglossus, scomber scombrus and thunnus albacares solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-9700
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SOUTHERN FLOUNDER (UNII: F8PTG78KRB) (SOUTHERN FLOUNDER - UNII:F8PTG78KRB) SOUTHERN FLOUNDER0.01 g  in 1 mL
ATLANTIC MACKEREL (UNII: HO615U86UJ) (ATLANTIC MACKEREL - UNII:HO615U86UJ) ATLANTIC MACKEREL0.01 g  in 1 mL
YELLOWFIN TUNA (UNII: 12ZC3K09X7) (YELLOWFIN TUNA - UNII:12ZC3K09X7) YELLOWFIN TUNA0.01 g  in 1 mL
ATLANTIC COD (UNII: RPX7J99EXW) (ATLANTIC COD - UNII:RPX7J99EXW) ATLANTIC COD0.01 g  in 1 mL
ATLANTIC HALIBUT (UNII: 7E34E106BO) (ATLANTIC HALIBUT - UNII:7E34E106BO) ATLANTIC HALIBUT0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-9700-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-9700-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
SHELLFISH MIX 
mercenaria mercenaria, callinectes sapidus, crassostrea virginica, placopecten magellanicus and farfantepenaeus aztecus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-9701
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BLUE CRAB (UNII: 8J18RFO4A8) (BLUE CRAB - UNII:8J18RFO4A8) BLUE CRAB0.01 g  in 1 mL
NORTHERN QUAHOG (UNII: D6G49OV9IM) (NORTHERN QUAHOG - UNII:D6G49OV9IM) NORTHERN QUAHOG0.01 g  in 1 mL
EASTERN OYSTER (UNII: 0I77C68AWS) (EASTERN OYSTER - UNII:0I77C68AWS) EASTERN OYSTER0.01 g  in 1 mL
SEA SCALLOP (UNII: BY65V9YV1I) (SEA SCALLOP - UNII:BY65V9YV1I) SEA SCALLOP0.01 g  in 1 mL
NORTHERN BROWN SHRIMP (UNII: TJH4LL437H) (NORTHERN BROWN SHRIMP - UNII:TJH4LL437H) NORTHERN BROWN SHRIMP0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-9701-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-9701-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
FLOUNDER 
paralichthys lethostigma solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5771
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SOUTHERN FLOUNDER (UNII: F8PTG78KRB) (SOUTHERN FLOUNDER - UNII:F8PTG78KRB) SOUTHERN FLOUNDER0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5771-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5771-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
MAINE LOBSTER 
homarus americanus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5772
Route of AdministrationPERCUTANEOUS, INTRADERMAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMERICAN LOBSTER (UNII: 6T362S6JF6) (AMERICAN LOBSTER - UNII:6T362S6JF6) AMERICAN LOBSTER0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5772-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5772-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
MACKEREL 
scomber scombrus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5773
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATLANTIC MACKEREL (UNII: HO615U86UJ) (ATLANTIC MACKEREL - UNII:HO615U86UJ) ATLANTIC MACKEREL0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5773-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5773-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
OYSTER 
crassostrea virginica solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5774
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EASTERN OYSTER (UNII: 0I77C68AWS) (EASTERN OYSTER - UNII:0I77C68AWS) EASTERN OYSTER0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5774-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5774-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
OCEAN PERCH 
sebastes alutus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5775
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PACIFIC OCEAN PERCH (UNII: 81369ZC3RW) (PACIFIC OCEAN PERCH - UNII:81369ZC3RW) PACIFIC OCEAN PERCH0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5775-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5775-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
SALMON 
salmo salar solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5776
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATLANTIC SALMON (UNII: 7062I37LB3) (ATLANTIC SALMON - UNII:7062I37LB3) ATLANTIC SALMON0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5776-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5776-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
SCALLOPS 
placopecten magellanicus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5777
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SEA SCALLOP (UNII: BY65V9YV1I) (SEA SCALLOP - UNII:BY65V9YV1I) SEA SCALLOP0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5777-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5777-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
SHRIMP 
farfantepenaeus aztecus solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5778
Route of AdministrationPERCUTANEOUS, INTRADERMAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NORTHERN BROWN SHRIMP (UNII: TJH4LL437H) (NORTHERN BROWN SHRIMP - UNII:TJH4LL437H) NORTHERN BROWN SHRIMP0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5778-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5778-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
LAKE TROUT 
oncorhynchus mykiss solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5779
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAINBOW TROUT (UNII: P4M52SZ8L6) (RAINBOW TROUT - UNII:P4M52SZ8L6) RAINBOW TROUT0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5779-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5779-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
TUNA 
thunnus albacares solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5780
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
YELLOWFIN TUNA (UNII: 12ZC3K09X7) (YELLOWFIN TUNA - UNII:12ZC3K09X7) YELLOWFIN TUNA0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5780-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5780-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
ALMOND FOOD 
prunus dulcis solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5781
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALMOND (UNII: 3Z252A2K9G) (ALMOND - UNII:3Z252A2K9G) ALMOND0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PHENOL (UNII: 339NCG44TV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5781-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:22840-5781-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
APPLE 
malus pumila solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5700
Route of AdministrationPERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
APPLE (UNII: B423VGH5S9) (APPLE - UNII:B423VGH5S9) APPLE0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5700-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5700-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
ENGLISH WALNUT 
juglans regia solution
Product Information
Product TypeNON-STANDARDIZED ALLERGENICItem Code (Source)NDC:22840-5789
Route of AdministrationSUBCUTANEOUS, INTRADERMAL, PERCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENGLISH WALNUT (UNII: 1V3SHR7QB7) (ENGLISH WALNUT - UNII:1V3SHR7QB7) ENGLISH WALNUT0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22840-5789-55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:22840-5789-210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10183309/15/1981
Labeler - Greer Laboratories, Inc. (024671414)
Registrant - Greer Laboratories, Inc. (024671414)
Establishment
NameAddressID/FEIBusiness Operations
Greer Laboratories, Inc.024671414manufacture(22840-1175, 22840-1176, 22840-1537, 22840-1538, 22840-5100, 22840-5101, 22840-5102, 22840-5103, 22840-5104, 22840-5105, 22840-5106, 22840-5107, 22840-5108, 22840-5109, 22840-5110, 22840-5111, 22840-5112, 22840-5113, 22840-5114, 22840-5115, 22840-5517, 22840-9100, 22840-9101, 22840-9102, 22840-9103, 22840-9104, 22840-9105, 22840-9107, 22840-1174, 22840-1100, 22840-1101, 22840-1102, 22840-1103, 22840-1105, 22840-1106, 22840-1107, 22840-1108, 22840-1110, 22840-1111, 22840-1112, 22840-1113, 22840-1116, 22840-1117, 22840-1118, 22840-1119, 22840-1121, 22840-1122, 22840-1123, 22840-1125, 22840-1126, 22840-1127, 22840-1128, 22840-1129, 22840-1130, 22840-1131, 22840-1133, 22840-1134, 22840-1135, 22840-1136, 22840-1138, 22840-1139, 22840-1140, 22840-1141, 22840-1142, 22840-1144, 22840-1145, 22840-1146, 22840-1147, 22840-1149, 22840-1150, 22840-1151, 22840-1153, 22840-1154, 22840-1155, 22840-1157, 22840-1159, 22840-1160, 22840-1162, 22840-1163, 22840-1164, 22840-1167, 22840-1168, 22840-1169, 22840-1170, 22840-1171, 22840-1173)

Revised: 5/2021
Document Id: c34fd349-042d-4a66-e053-2995a90a24a5
Set id: 79ebe899-98e4-f44f-e053-2a91aa0ad6d6
Version: 4
Effective Time: 20210527
 
Greer Laboratories, Inc.