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 31 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreen Company	b4d8860b-d72f-4789-945e-1c6420a8efab	2025-12-02	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	WALGREEN COMPANY	f7b304d8-e37c-4ac6-b4a2-1797b92cb832	2025-12-01	Warnings	Exact identifier application number: M013
Dye FreeInfants Pain and Fever	ACETAMINOPHEN	WALGREEN COMPANY	1a304570-88b6-4c16-a8b4-c064bfa5d95a	2025-12-01	Warnings	Exact identifier application number: M013
Walgreen Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	WALGREENS	b48d93fe-bb60-493f-8d1a-b2dc864203c4	2025-12-01	Warnings	Exact identifier application number: M013
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	WALGREEN CO.	6c4ab613-a587-4ec4-9986-f1d000bc2d23	2025-12-01	Warnings	Exact identifier application number: M013
WAG HBP Daytime and Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREENS CO.	ac2f9ce8-e402-4451-a412-e99248a6ecbe	2025-12-01	Warnings	Exact identifier application number: M013
Walgreen Day Time NightTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESIN	WALGREENS CO.	5505217a-9679-4668-bdab-5d4553a47c56	2025-12-01	Warnings	Exact identifier application number: M013
CAREALL Aspirin	ASPIRIN	New World Imports, Inc	58a371d4-1f00-4fda-8e08-80610c58505a	2025-12-01	Warnings	Exact identifier application number: M013
CareALL Non Aspirin Extra Strength	ACETAMINOPHEN	New World Imports, Inc	da05a1a1-35b4-4787-8c56-12e369f18ff0	2025-12-01	Warnings	Exact identifier application number: M013
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	80a699b9-bf5c-4765-9e20-ccbc7e3ace7a	2025-12-01	Warnings	Exact identifier application number: M013
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	66244cdb-2680-4fa8-890d-32aefd490038	2025-12-01	Warnings	Exact identifier application number: M013
Family Wellness Childrens Pain Reliever 574	ACETAMINOPHEN	Family Dollar Services, Inc.	902c1136-04d2-41f0-81c6-412663cdf378	2025-12-01	Warnings	Exact identifier application number: M013
WalgreenChildrens Pain Fever	ACETAMINOPHEN	WALGREENS CO.	2f757cde-2604-4ca4-b54e-e444f3757cdd	2025-11-26	Warnings	Exact identifier application number: M013
Walgreen Childrens Pain plus Fever	ACETAMINOPHEN	WALGREENS CO.	29ca2855-3c07-435d-a8e1-2997fcedd088	2025-11-26	Warnings	Exact identifier application number: M013
Walgreens Childrens Cold plus Cough plus Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	8714d4e6-3a3b-48c8-8ac1-51b933a2ceac	2025-11-26	Warnings	Exact identifier application number: M013
Pain Reliever, 24/7 Life by 7-Eleven	ACETAMINOPHEN TABLET, FILM COATED	Lil' Drug Store Products, Inc.	44828b89-2563-b233-e063-6294a90ab124	2025-11-26	Warnings	Exact identifier application number: M013
MEMBERS MARK ACETAMINOPHEN	ACETAMINOPHEN	Sam's West Inc	03e831d4-8060-4633-9d02-e77100063fb4	2025-11-26	Warnings	Exact identifier application number: M013
Childrens Pain and Fever Dissolve Packs	ACETAMINOPHEN	WALGREENS CO.	ea0f265f-7d64-4731-beda-0bb841dd1ad7	2025-11-25	Warnings	Exact identifier application number: M013
Sore Throat Logenzes Sore Throat	BENZOCAINE AND MENTHOL	ATLANTIC BIOLOGICALS CORP.	71a80e13-bda3-40fb-b4e7-45e9985e707c	2025-11-24	Warnings	Exact identifier application number: M013
better living brands childrens fever and pain reliver	ACETAMINOPHEN	BETTER LIVING BRANDS LLC	c13ced61-c491-4fc2-b83f-78c6d9ad8546	2025-11-20	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