DailyMed - MODEL AA-1218CEV- kit

NHRIC Code(s): 27860-010-11
Packager: Aerospace Accessory Service, Inc
This is a repackaged label.
Source NDC Code(s): 65785-160

Category: MEDICAL DEVICE
DEA Schedule: None
Marketing Status: Exempt device

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Updated May 5, 2021

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Aerospace Accessory Service

Aerospace Accessory Service

P/N:

S/N:

EXP:

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INGREDIENTS AND APPEARANCE

MODEL AA-1218CEV
first aid kit with drug kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:27860-010

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:27860-010-11	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1		1
Part 2		1
Part 3		1
Part 4		1
Part 5		1
Part 6		1
Part 7		1
Part 8		1
Part 9		1
Part 10		1
Part 11		1

Part 1 of 11

MOORE MEDICAL NON ASPIRIN
acetaminophen tablet, film coated

Product Information
Item Code (Source)	NDC:55670-467
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	AZ;234
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	12/30/2008

Part 2 of 11

MOORE MEDICAL ANTACID
calcium carbonate tablet, chewable

Product Information
Item Code (Source)	NDC:55670-142
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	420 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor	MINT (MINT)	Imprint Code	FR;8
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	12/30/2008

Part 3 of 11

AMMONIA INHALANTS
ammonia inhalants inhalant

Product Information
Item Code (Source)	NDC:46414-3333
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	0.045 g in 0.3 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/14/1976

Part 4 of 11

EASY CARE FIRST AID DIPHENHYDRAMINE
diphenhydramine hydrochloride tablet, film coated

Product Information
Item Code (Source)	NDC:44224-0017
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (pink)	Score	no score
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	048;D
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/01/2012

Part 5 of 11

BZK PADS
benzalkonium chloride swab

Product Information
Item Code (Source)	NDC:67777-245
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/05/2011

Part 6 of 11

POVIDONE-IODINE
povidone-iodine solution

Product Information
Item Code (Source)	NDC:46414-7777
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/14/1976

Part 7 of 11

MOORE MEDICAL BISMUTH
bismuth subsalicylate tablet, chewable

Product Information
Item Code (Source)	NDC:55670-474
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTRATES (UNII: G263MI44RU)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	16mm
Flavor		Imprint Code	RH;046
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	04/01/2014

Part 8 of 11

MOOREBRAND PHENYLEPHRINE
phenylephrine hydrochloride tablet, film coated

Product Information
Item Code (Source)	NDC:55670-163
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	red (red)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	271
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/30/2008

Part 9 of 11

STYE
mineral oil and petrolatum gel

Product Information
Item Code (Source)	NDC:63736-238
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	319 mg in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	577 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
WHEAT GERM OIL (UNII: 14C97E680P)

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	06/15/2010

Part 10 of 11

ANTIMICROBIAL
alcohol liquid

Product Information
Item Code (Source)	NDC:61010-3111
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	alcohol	665 mL in 1 L

Ingredient Name	Strength
Inactive Ingredients
aloe (UNII: V5VD430YW9)
water (UNII: 059QF0KO0R)
trolamine (UNII: 9O3K93S3TK)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/21/2012

Part 11 of 11

PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH
purified water 98.3% solution

Product Information
Item Code (Source)	NDC:0924-0160(NDC:65785-160)
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	929 g in 946 mL

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA022305	06/12/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
exempt device	ABC	01/01/2015

Labeler - Aerospace Accessory Service, Inc (859100547)

Registrant - Aerospace Accessory Service, Inc (859100547)

Name	Address	ID/FEI	Business Operations
Establishment
Aerospace Accessory Service, Inc		859100547	manufacture, repack

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Published Date (What is this?)	Version	Files
May 6, 2021	2 (current)	download
Jan 11, 2021	1	download

	RxCUI	RxNorm NAME	RxTTY
1	308761	bismuth subsalicylate 262 MG Chewable Tablet	PSN
2	308761	bismuth subsalicylate 262 MG Chewable Tablet	SCD
3	312564	povidone-iodine 10 % Topical Solution	PSN
4	312564	povidone-iodine 100 MG/ML Topical Solution	SCD
5	312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY
6	313782	acetaminophen 325 MG Oral Tablet	PSN
7	313782	acetaminophen 325 MG Oral Tablet	SCD
8	313782	APAP 325 MG Oral Tablet	SY
9	313884	calcium carbonate 420 MG (Ca 168 MG) Chewable Tablet	PSN
10	313884	calcium carbonate 420 MG Chewable Tablet	SCD
11	313884	calcium carbonate 420 MG (calcium 168 MG) Chewable Tablet	SY
12	579999	mineral oil 31.9 % / petrolatum 57.7 % Ophthalmic Ointment	PSN
13	579999	mineral oil 0.319 MG/MG / petrolatum 0.577 MG/MG Ophthalmic Ointment	SCD
14	579999	mineral oil 31.9 % / petrolatum, white 57.7 % Ophthalmic Ointment	SY
15	1038558	benzalkonium chloride 0.13 % Medicated Pad	PSN
16	1038558	benzalkonium chloride 1.3 MG/ML Medicated Pad	SCD
17	1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Patch	SY
18	1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Swab	SY
19	1038558	benzalkonium chloride 0.13 % Topical Swab	SY
20	1038558	benzalkonium chloride 1 ML per 750 ML Topical Swab	SY
21	1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN
22	1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD
23	1053146	Stye 31.9 % / 57.7 % Ophthalmic Ointment	PSN
24	1053146	mineral oil 0.319 MG/MG / petrolatum 0.577 MG/MG Ophthalmic Ointment [Stye]	SBD
25	1053146	Stye (mineral Oil 0.319 MG/MG / petrolatum, white 0.577 MG/MG) Ophthalmic Ointment	SY
26	1053146	Stye (mineral oil 31.9 % / petrolatum, white 57.7 % ) Ophthalmic Ointment	SY
27	1087912	ethanol 66.5 % Topical Solution	PSN
28	1087912	ethanol 0.665 ML/ML Topical Solution	SCD
29	1087912	ethanol 66.5 % Topical Solution	SY
30	1151101	water 98.3 % Ophthalmic Irrigation Solution	PSN
31	1151101	water 983 MG/ML Ophthalmic Irrigation Solution	SCD
32	1151101	water 98.3 % Ophthalmic Irrigation Solution	SY
33	1299145	phenylephrine HCl 5 MG Oral Tablet	PSN
34	1299145	phenylephrine hydrochloride 5 MG Oral Tablet	SCD
35	1299145	phenylephrine HCl 5 MG Oral Tablet	SY
36	1299889	ammonia 15 % Nasal Inhalant	PSN
37	1299889	ammonia 150 MG/ML Nasal Inhalant	SCD
38	1299889	ammonia 0.045 GM per 0.3 ML Nasal Inhalant	SY
39	1299889	ammonia 0.3 ML Nasal Inhalant	SY
40	1299889	ammonia 15 % Nasal Inhalant	SY

Label: MODEL AA-1218CEV- kit

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Label: MODEL AA-1218CEV- kit

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MODEL AA-1218CEV- kit

Number of versions: 2

MODEL AA-1218CEV- kit

MODEL AA-1218CEV- kit

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MODEL AA-1218CEV- kit

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.