Label: PHENYLEPHRINE HYDROCHLORIDE solution/ drops

  • NDC Code(s): 70512-865-02, 70512-865-15, 70512-866-05
  • Packager: SOLA Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 30, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP.

    PHENYLEPHRINE HYDROCHLORIDE ophthalmic solution, USP 2.5% and 10%.
    Initial U.S. Approval: 1939

    INDICATIONS AND USAGE

    Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil ( 1)

    DOSAGE AND ADMINISTRATION

    For patients 1 year of age and older: ( 2.1)

    • Apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution (2.5% or 10% strength) to conjunctival fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye.
    • To obtain a greater degree of mydriasis, use 10% strength

    For pediatric patients less than 1 year of age: ( 2.2)

    • Instill one drop of 2.5% strength to conjunctival fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye

    DOSAGE FORMS AND STRENGTHS

    Ophthalmic solution (sterile): ( 3)

    • 25 mg of phenylephrine hydrochloride in one mL of solution (2.5%)
    • 100 mg of phenylephrine hydrochloride in one mL of solution (10%)

    CONTRAINDICATIONS

    The 10% strength is contraindicated in:

    • Patients with hypertension, or thyrotoxicosis ( 4.1)
    • Pediatric patients less than 1 year of age due to increased risk of systemic toxicity ( 4.2)

    WARNINGS AND PRECAUTIONS

    • Not for injection: Topical ophthalmic use only ( 5.1)
    • Serious cardiovascular reactions with 10% strength: Reactions have included ventricular arrhythmias and some have been fatal. Monitor blood pressure in patients with cardiovascular disease ( 5.2).
    • Significant elevations in blood pressure: Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk, monitor blood pressure post treatment ( 5.3).
    • Rebound miosis: Reported one day after instillation ( 5.4)

    ADVERSE REACTIONS

    • Ocular adverse reactions include eye pain and stinging on instillation, temporary blurred vision, and photophobia ( 6.1)
    • Cardiovascular adverse reactions include increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage ( 6.2)

    To report SUSPECTED ADVERSE REACTIONS, contact SOLA Pharmaceuticals at 1-866-747-7365 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    DRUG INTERACTIONS

    • Atropine-like drugs: May exaggerate the adrenergic pressor response ( 7.1)
    • Potent inhalation anesthetic agents: May potentiate cardiovascular depressant effects ( 7.1)

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 2/2024

  • Table of Contents

    FULL PRESCRIBING INFORMATION: CONTENTS*

    1 INDICATIONS AND USAGE

    2 DOSAGE AND ADMINISTRATION

    2.1 General Dosing Recommendations

    2.2 Dosing in Pediatric Patients Less Than 1 Year of Age

    3 DOSAGE FORMS AND STRENGTHS

    4 CONTRAINDICATIONS

    4.1 Cardiac and Endocrine Disease

    4.2 Pediatric Patients Less Than 1 Year of Age

    5 WARNINGS AND PRECAUTIONS

    5.1 Topical Ophthalmic Use Only

    5.2 Cardiovascular Reactions

    5.3 Elevation of Blood Pressure

    5.4 Rebound Miosis

    6 ADVERSE REACTIONS

    6.1 Ocular Adverse Reactions

    6.2 Systemic Adverse Reactions

    7 DRUG INTERACTIONS

    7.1 Agents That May Exaggerate Pressor Response

    8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    8.3 Nursing Mothers

    8.4 Pediatric Use

    8.5 Geriatric Use

    10 OVERDOSAGE

    11 DESCRIPTION

    12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    12.2 Pharmacodynamics

    12.3 Pharmacokinetics

    14 CLINICAL STUDIES

    16 HOW SUPPLIED/STORAGE AND HANDLING

    17. PATIENT COUNSELING INFORMATION

    *
    Sections or subsections omitted from the full prescribing information are not listed.
  • 1 INDICATIONS AND USAGE

    Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.

  • 2 DOSAGE AND ADMINISTRATION

    2.1 General Dosing Recommendations

    In patients 1 year of age or greater, apply one drop of either phenylephrine hydrochloride ophthalmic solution 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops per eye per day.

    In order to obtain a greater degree of mydriasis, phenylephrine hydrochloride ophthalmic solution 10% may be needed.

    2.2 Dosing in Pediatric Patients Less Than 1 Year of Age

    In pediatric patients less than 1 year of age, one drop of phenylephrine hydrochloride ophthalmic solution 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.

  • 3 DOSAGE FORMS AND STRENGTHS

    Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is a clear, colorless to yellow solution, sterile topical ophthalmic solution containing phenylephrine hydrochloride 2.5%: each mL contains 25 mg of phenylephrine hydrochloride.

    Phenylephrine hydrochloride ophthalmic solution, USP 10% is a clear, colorless to yellow solution, sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%.: each mL contains 100 mg of phenylephrine hydrochloride.

  • 4 CONTRAINDICATIONS

    4.1 Cardiac and Endocrine Disease

    Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients.

    4.2 Pediatric Patients Less Than 1 Year of Age

    Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [See Dosage and Administration ( 2.2)] .

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Topical Ophthalmic Use Only

    Phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is not indicated for injection.

    5.2 Cardiovascular Reactions

    There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using phenylephrine 10%. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients.

    5.3 Elevation of Blood Pressure

    A significant elevation in blood pressure is not common but has been reported following conjunctival instillation of recommended doses of phenylephrine 10%. The risk is less with phenylephrine 2.5%. Caution should be exercised with the use of phenylephrine 10% in pediatric patients less than 5 years of age and patients with hyperthyroidism, or cardiovascular disease. The post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms should be carefully monitored.

    5.4 Rebound Miosis

    Rebound miosis has been reported one day after receiving phenylephrine hydrochloride ophthalmic solution, and re-instillation of the drug produced a lesser mydriatic effect.

  • 6 ADVERSE REACTIONS

    The following serious adverse reactions are described below and elsewhere in the labeling:

    • Cardiovascular Effects [ See Warnings and Precautions ( 5.2)]
    • Elevation in Blood Pressure [ See Warnings and Precautions ( 5.3)]

    The following adverse reactions have been identified following use of phenylephrine hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    6.1 Ocular Adverse Reactions

    Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur.

    6.2 Systemic Adverse Reactions

    A marked increase in blood pressure has been reported particularly, but not limited to low weight premature neonates, infants and hypertensive patients.

    Cardiovascular effects which have been seen primarily in hypertensive patients following topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage [ See Warnings and Precautions ( 5.2and 5.3)].

  • 7 DRUG INTERACTIONS

    7.1 Agents That May Exaggerate Pressor Response

    Concomitant use of phenylephrine and atropine may enhance the pressor effects and induce tachycardia in some patients. Phenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic agents.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Animal reproduction studies have not been conducted with topical phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed.

    8.3 Nursing Mothers

    It is not known whether this drug is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is administered to a nursing woman.

    8.4 Pediatric Use

    Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age [ See Contraindications ( 4.2) ].

    8.5 Geriatric Use

    No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

  • 10 OVERDOSAGE

    Overdosage of phenylephrine may cause a rapid rise in blood pressure. It may also cause headache, anxiety, nausea, and vomiting, and ventricular arrhythmias. Prompt injection of a rapidly acting alpha-adrenergic blocking agent such as phentolamine has been recommended.

  • 11 DESCRIPTION

    Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless, topical - adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure

    Chemical Structure

    Chemical Name: (R)-3-hydroxy- [(methylamino)methyl]benzenemethanol hydrochloride.
    Molecular Formula: C 9H 13NO 2.HCl
    Molecular Weight: 203.67 g/mol

    Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).

    Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Phenylephrine hydrochloride is an -1 adrenergic agonist drug that is used in ophthalmology mainly for its mydriatic effect. After topical application to the conjunctiva, phenylephrine acts directly on α-adrenergic receptors in the eye, producing contraction of the dilator muscle of the pupil and constriction of the arterioles in the conjunctiva.

    12.2 Pharmacodynamics

    Maximal mydriasis occurs in 20 to 90 minutes with recovery after 3 to 8 hours. Systemic absorption of sufficient quantities of phenylephrine may lead to systemic α-adrenergic effects, such as rise in blood pressure which maybe accompanied by a reflex atropine-sensitive bradycardia.

    12.3 Pharmacokinetics

    The systemic exposure following topical administration of phenylephrine hydrochloride ophthalmic solution has not been studied. A higher systemic absorption is expected for the 10% solution than the 2.5% solution and when the corneal barrier function is compromised.

  • 14 CLINICAL STUDIES

    Pupillary dilation following topical administration of phenylephrine hydrochloride ophthalmic solution has been demonstrated in controlled clinical studies in adults and pediatric patients with different levels of iris pigmentation. Pupil movement is generally seen within 15 minutes, maximal mydriasis between 20 to 90 minutes and recovery after 3 to 8 hours. Darker irides tend to dilate slower than lighter irides.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is supplied as a sterile, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes:

    NDC 70512-865-02         2 mL in 5mL bottle
    NDC 70512-865-15         15 mL in 15 mL bottle

    Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is supplied as a sterile, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes:

    NDC 70512-866-05         5 mL in 10 mL bottle

    After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle.

    Storage:Store at 20° to 25°C (68° to 77°F).
    [see USP Controlled Room Temperature.]

    Keep container tightly closed.
    Protect from light and excessive heat.
    Do not use if solution is brown or contains precipitate.

  • 17. PATIENT COUNSELING INFORMATION

    Advise patients not to touch the dropper tip to any surface as this may contaminate the solution. Inform patients that they may experience sensitivity to light and should protect their eyes in bright illumination while their pupils are dilated.

    Manufactured for
    SOLA Pharmaceuticals
    Baton Rouge, LA 70810
    Made in India
    Code: TN/Drugs/TN00003457
    Rev. 02/2024
    22200794

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 70512-865-02

    Phenylephrine Hydrochloride
    Opthalmic Solution, USP

    2.5%

    For eye use only

    Rx only 2mL

    After opening, Phenylephrine HCI
    Opthalmic Solution, USP can be used
    until the expiration date on the bottle.
    Usual Dosage:See package insert for
    dosage information.
    Note:Bottle filled to 1/3 capacity for
    proper drop control.

    DO NOT USE IF TAMPER EVIDENT
    SEAL IS MISSING OR NOT INTACT.

    22200772 Code TN/Drugs/TN00003457

    Each mL contains:
    Active:Phenylephrine Hydrochloride (2.5%)
    Preservative: Benzalkonium Chloride
    0.1 mg (0.01%)
    Storage:Store at 20° to 25°C (68° to 77°F).
    Keep container tightly closed. Do not use if
    solution is brown or contains a precipitate.

    Manufactured for:
    SOLA Pharmaceuticals
    Baton Rouge, LA 70810
    Made in India

    LOT:

    EXP:

    2mL label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 70512-865-02

    Phenylephrine
    Hydrochloride
    Ophthalmic
    Solution, USP

    2.5%

    For Eye Use Only

    SOLA

    Rx Only 2 mL

    Each mL contains:
    Active: Phenylephrine Hydrochloride
    25 mg (2.5%)
    Inactives:Sodium Phosphate Dibasic
    Sodium Phosphate Monobasic, Sodium
    Hydroxide and/or Phosphoric Acid may
    be added to adjust pH (4.0 to 7.5) and
    Water for Injection q.s.
    Preservative: Benzalkonium Chloride
    0.1 mg (0.01%)

    Do not use if solution is brown or
    contains a precipitate.

    KEEP OUT OF REACH OF CHILDREN.

    Usual Dosage:See package insert for
    dosage information.

    Storage:Store at 20° to 25°C (68° to
    77°F). [see USP Controlled Room
    Temperature]

    DO NOT USE IF TAMPER EVIDENT
    SEAL IS MISSING OR NOT INTACT.

    Do not touch dropper tip to any surface,
    as this may contaminate the solution.

    Keep container tightly closed. Protect
    from light and excessive heat.

    Note:Bottle filled to 1/3 capacity
    for proper drop control.

    Manufactured for:
    SOLA Pharmaceuticals
    Baton Rouge, LA 70810

    Made in India

    Code: TN/Drugs/TN00003457

    22200787

    2mL Carton
  • PRINCIPAL DISPLAY PANEL

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 70512-865-15

    Phenylephrine
    Hydrochloride
    Opthalmic
    Solution, USP

    2.5%

    For eye use only

    Rx only 15mL

    After opening, Phenylephrine
    HCI Opthalmic Solution,
    USP can be used until the
    expiration date on the bottle.
    Usual Dosage:See package
    insert for dosage information.

    DO NOT USE IF TAMPER
    EVIDENT SEAL IS MISSING
    OR NOT INTACT.

    Each mL contains:
    Active:Phenylephrine Hydrochloride (2.5%)
    Inactives: Sodium Phosphate Dibasic Sodium
    Phosphate Monobasic, Sodium Hydroxide and/or
    Phosphoric Acid may be added to
    adjust pH (4.0 to 7.5) and Water for
    Injection q.s.
    Preservative: Benzalkonium Chloride
    0.1 mg (0.01%)
    Storage:Store at 20° to 25°C (68° to
    77°F). Keep container tightly closed.
    Do not use if solution is brown or
    contains a precipitate.
    Protect from light and excessive heat.

    Manufactured for:
    SOLA Pharmaceuticals
    Baton Rouge, LA 70810
    Made in India

    22200784 Code: TNDRUGS/TN0003457

    LOT:

    EXP:

    15mL Label

    Principal Display Panel Text for Carton Label:

    NDC 70512-865-15

    Phenylephrine
    Hydrochloride
    Ophthalmic
    Solution, USP

    2.5%

    For Eye Use Only

    SOLA

    Rx Only 15 mL

    Each mL contains:
    Active: Phenylephrine Hydrochloride
    25 mg (2.5%)
    Inactives: Sodium Phosphate
    Dibasic, Sodium Phosphate
    Monobasic, Sodium Hydroxide
    and/or Phosphoric Acid may
    be added to adjust pH (4.0 to 7.5)
    and Water for Injection q.s.
    Preservative: Benzalkonium
    Chloride 0.1 mg (0.01%)

    Do not use if solution is brown or
    contains a precipitate.

    KEEP OUT OF REACH OF
    CHILDREN.

    Usual Dosage: See package insert for
    dosage information.

    Storage: Store at 20° to 25°C (68°
    to 77°F). [see USP Controlled
    Room Temperature]

    DO NOT USE IF TAMPER EVIDENT
    SEAL IS MISSING OR NOT INTACT.

    Do not touch dropper tip to any
    surface, as this may contaminate
    the solution.

    Keep container tightly closed.
    Protect from light and excessive
    heat.

    Manufactured for:
    SOLA Pharmaceuticals
    Baton Rouge, LA 70810

    Made in India

    Code: TN/Drugs/TN00003457

    22200789

    15mL Carton

    Principal Display Panel Text for Container Label:

    NDC 70512-866-05

    Phenylephrine Hydrochloride
    Opthalmic Solution, USP

    10%

    For eye use only

    Rx only 5mL

    After opening, Phenylephrine
    HCI Opthalmic Solution, USP
    can be used until the
    expiration date on the bottle.
    Usual Dosage:See package
    insert for dosage information.
    Note:Bottle filled to 1/2
    capacity for proper drop control.

    DO NOT USE IF TAMPER
    EVIDENT SEAL IS MISSING
    OR NOT INTACT.

    Each mL contains:
    Active:Phenylephrine Hydrochloride (10%)
    Preservative: Benzalkonium Chloride
    0.1 mg (0.01%)
    Storage:Store at 20° to 25°C
    (68° to 77°F).
    Keep container tightly closed. Do not use if
    solution is brown or contains a precipitate.

    Manufactured for:
    SOLA Pharmaceuticals
    Baton Rouge, LA 70810
    Made in India

    Code: TN/Drugs/TN00003457 22200778

    LOT:

    EXP:

    5mL Label

    Principal Display Panel Text for Carton Label:

    NDC 70512-866-05

    Phenylephrine
    Hydrochloride
    Ophthalmic
    Solution, USP

    10%

    For Eye Use Only

    SOLA

    Rx Only 5 mL

    Each mL contains:
    Active: Phenylephrine Hydrochloride
    100 mg (10%)
    Inactives: Sodium Phosphate Dibasic,
    Sodium Phosphate Monobasic,
    Sodium Hydroxide and/or Phosphoric
    Acid may be added to adjust pH (4.0 to
    7.5) and Water for Injection q.s.
    Preservative: Benzalkonium Chloride
    0.1 mg (0.01%)

    Do not use if solution is brown or
    contains a precipitate.

    KEEP OUT OF REACH OF
    CHILDREN.

    Usual Dosage: See package insert for
    dosage information.

    Storage: Store at 20° to 25°C (68° to
    77°F). [see USP Controlled Room
    Temperature]

    DO NOT USE IF TAMPER EVIDENT
    SEAL IS MISSING OR NOT INTACT.

    Do not touch dropper tip to any
    surface, as this may contaminate
    the solution.

    Keep container tightly closed. Protect
    from light and excessive heat.
    Note: Bottle filled to 1/2 capacity for
    proper drop control.

    Manufactured for:
    SOLA Pharmaceuticals
    Baton Rouge, LA 70810

    Made in India

    Code: TN/Drugs/TN00003457

    22200788

    5mL Carton
  • INGREDIENTS AND APPEARANCE
    PHENYLEPHRINE HYDROCHLORIDE 
    phenylephrine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70512-865
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70512-865-021 in 1 CARTON06/01/2024
    12 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:70512-865-151 in 1 CARTON06/01/2024
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21518306/01/2024
    PHENYLEPHRINE HYDROCHLORIDE 
    phenylephrine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70512-866
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70512-866-051 in 1 CARTON06/01/2024
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21518306/01/2024
    Labeler - SOLA Pharmaceuticals, LLC (080121345)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!