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 17 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	318cc982-23a9-4804-b6fb-248f772d7a38	2026-04-02	Warnings	Exact identifier application number: M013
Chewable Acetaminophen Childrens	ACETAMINOPHEN	Cardinal Health 110, LLC. DBA Leader	8a18565c-b84e-43f8-8e96-e1dbcc39f08b	2026-04-02	Warnings	Exact identifier application number: M013
Childrens Pain Reliever	ACETAMINOPHEN	H E B	c713556c-cb9e-4ed2-bc2f-49b3d6256c0f	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Discount Drug Mart	4a1e9c79-5036-4c69-82f9-e48abc972b47	2026-04-02	Warnings	Exact identifier application number: M013
Wispirin	ASPIRIN	Wisdrug AG	4e70ec5e-d033-a525-e063-6394a90a5a93	2026-04-01	Warnings	Exact identifier application number: M013
Aspirin Regimen	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	ef2d75ee-9ed7-4b53-adbc-2ec40364da63	2026-03-31	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	Hi-Tech Nutraceuticals, LLC	b119ba37-0ee3-851a-e053-2995a90a85b1	2026-03-31	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	RMT HEALTH LLC	4dc7229d-c895-1f80-e063-6394a90abfc3	2026-03-30	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PD-Rx Pharmaceuticals, Inc.	d1f05e56-c830-4f85-b685-2a5965d10a1c	2026-03-26	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	ad01aea6-4af3-469b-b99d-e1e66aa40e8d	2026-03-25	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Meijer Distribution Inc	c550b92e-de54-4599-9534-bd3022b0a86d	2026-03-25	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	AmerisourceBergen (Good Neighbor Pharmacy) 46122	db187226-0770-4934-90a4-c6ca50bdecef	2026-03-25	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	804d4b63-1bbe-47c0-ad49-39ddbeade6a3	2026-03-25	Warnings	Exact identifier application number: M013
childrens pain and fever	ACETAMINOPHEN	HyVee Inc	9d9c2bf6-8660-4987-8794-936d3102da8d	2026-03-24	Warnings	Exact identifier application number: M013
Childrens Pain Reliever	ACETAMINOPHEN	BJWC (Berkley & Jensen / BJ's)	851228ea-eaf3-452b-a9ce-8cd244a0eaf3	2026-03-24	Warnings	Exact identifier application number: M013
FirstCare Childrens Pain Fever Acetaminophen	ACETAMINOPHEN 80 MG	USpharma Ltd	9fc05ba6-5667-457e-82c1-a8b4e16cadda	2026-03-23	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Aarkish Pharmaceuticals NJ Inc.	e5e9e1ce-666a-461f-8287-a4642902067c	2026-03-23	Warnings	Exact identifier application number: M013
Chewable Aspirin Low Dose	CHEWABLE ASPIRIN	Grocery Outlet	609c0389-8bed-4483-84fa-73ee73fdb4e4	2026-03-20	Warnings	Exact identifier application number: M013
Adult Low Dose Pain Reliever	ASPIRIN	TWIN MED LLC	a395acf4-f487-4c98-8c44-ca2aaaf72deb	2026-03-20	Warnings	Exact identifier application number: M013
Rapidol	ACETAMINOPHEN	Pharmadel LLC	3a210860-1fc1-e496-e063-6394a90a8705	2026-03-20	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