ED APAP

Product NDC: 0485-0057
11-digit product format: 004850057
Labeler code: 0485
Product ID: 0485-0057_4742634e-a794-9047-e063-6394a90a2cd3
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: LIQUID
Route: ORAL
Labeler: EDWARDS PHARMACEUTICALS, INC.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-03-07
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: ED APAP
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307675	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f76d5fff-ebea-40f9-aad3-4064a0c863f0	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-08-10	Ed-EdAPAPChild 0057
2023-07-28	Ed-EdAPAPChild 0057
2020-04-08	Ed-EdAPAPChild 0057
2020-01-31	Ed-EdAPAPChild 0057

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0485-0057-08	ED APAP	236 mL in 1 BOTTLE, PLASTIC	LIQUID	236		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0485-0057-08	ML - Milliliter	0485-0057	7b26afc0-0dc5-4bbc-9c56-7f3aecd41bfd	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0485-0057	ED APAP (ACETAMINOPHEN) LIQUID [EDWARDS PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20241228_f76d5fff-ebea-40f9-aad3-4064a0c863f0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 51 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pediacare Childrens Acetaminophen Grape	ACETAMINOPHEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	596372c7-eca3-4527-8e22-ab0751e2526b	2024-12-30	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	BAYER GENUINE ASPIRIN	Lil' Drug Store Products, Inc.	d17834d7-cb3e-6bf2-e053-2a95a90ae5c1	2024-12-30	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG, FILM-COATED CAPLET	Lil' Drug Store Products, Inc.	e5fd2b46-683e-4cf5-e053-2995a90a5512	2024-12-30	Warnings	Exact identifier application number: M013
Night Time Severe Cold and Cough Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Chain Drug Consortium, LLC	c8e9b57b-83e9-46c5-9791-02c4c2b94004	2024-12-29	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC.	1608b4f0-bf20-4024-b8f2-20a4df7a4b21	2024-12-26	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Advance Pharmaceutical Inc.	f6a9ea44-08b8-4a33-bfbd-68cb2d852c39	2024-12-26	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	cfc7eac3-35be-4002-b8ef-be1dfc8caf69	2024-12-26	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	a3031139-4709-43f2-95a8-89840c595f7f	2024-12-26	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	WALGREENS CO.	98bb28ed-d146-ca3d-e053-2a95a90a9eaf	2024-12-26	Warnings	Exact identifier application number: M013
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg	ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG	WALGREENS CO.	982faa74-d498-cd1e-e053-2995a90afa1e	2024-12-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	AptaPharma Inc.	11bf6e1b-aed9-4f8f-9f03-ea911ae9f702	2024-12-23	Warnings	Exact identifier application number: M013
Rugby Regular Strength Acetaminophen	ACETAMINOPHEN	RUGBY LABORATORIES	295b0d00-4d4a-405f-9325-d01c5d4f3ed4	2024-12-20	Warnings	Exact identifier application number: M013
Walgreens Pain Relief Powder	ASPIRIN AND CAFFEINE	Walgreens Co.	61493d34-2432-4683-9b32-e1851a4337be	2024-12-18	Warnings	Exact identifier application number: M013
Reese Headache Powders	ASPIRIN AND CAFFEINE	Reese Pharmaceutical Co	386f7a6c-4bfc-4140-a67b-07f6b520d58f	2024-12-18	Warnings	Exact identifier application number: M013
NobleAid PAIN RELIEVER	ASPIRIN	Noble Otc LLC	aa08e488-2f69-4d7e-86ba-ccfad563edcf	2024-12-18	Warnings	Exact identifier application number: M013
Dollar General Headache Powders	ASPIRIN AND CAFFEINE	Dolgencorp, LLC	11b0271b-d65c-49c4-a081-d71044a0e04c	2024-12-18	Warnings	Exact identifier application number: M013
Family Wellness Pain Relief Powder	ASPIRIN AND CAFFEINE	Family Dollar Services Inc	b2e55de7-3c36-49cc-8f7f-1013fd1ec359	2024-12-18	Warnings	Exact identifier application number: M013
Best Choice Pain Relief Powder	ASPIRIN AND CAFFEINE	Value Merch	a95b9b22-ea5c-4a02-b35d-c8ae1e117604	2024-12-18	Warnings	Exact identifier application number: M013
Walmart Pain Relief Powder	ASPIRIN AND CAFFEINE	Walmart	c69aa61f-6a74-40a3-8737-195fa545e261	2024-12-18	Warnings	Exact identifier application number: M013
Quality Choice Pain Relief Powder	ASPIRIN AND CAFFEINE	Chain Drug Marketing Association	8e1f4057-4968-4523-9b3f-55aea421b674	2024-12-18	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307675	acetaminophen 160 MG in 5 mL Oral Solution	PSN	f76d5fff-ebea-40f9-aad3-4064a0c863f0	7
307675	acetaminophen 32 MG/ML Oral Solution	SCD	f76d5fff-ebea-40f9-aad3-4064a0c863f0	7
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	f76d5fff-ebea-40f9-aad3-4064a0c863f0	7
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	f76d5fff-ebea-40f9-aad3-4064a0c863f0	7
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	f76d5fff-ebea-40f9-aad3-4064a0c863f0	7
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	f76d5fff-ebea-40f9-aad3-4064a0c863f0	7
307675	APAP 32 MG/ML Oral Solution	SY	f76d5fff-ebea-40f9-aad3-4064a0c863f0	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0485-0057-08	00485005708	236 mL in 1 BOTTLE, PLASTIC (0485-0057-08)	236 ml	2012-03-07	0000-00-00	No	No	Current