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 50 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ASPIRIN 325 MG EC	ASPIRIN	Reliable 1 Laboratories LLC	2ab8564f-f958-7512-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 325 MG	ACETAMINOPHEN	Reliable 1 Laboratories LLC	25626b46-78f8-7226-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	Reliable 1 Laboratories LLC	b247fe39-7f65-e502-e053-2a95a90a08f1	2025-01-15	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN 500MG	Ulai Health LLC	e64ce7b1-4501-4b51-b012-1882ed153b42	2025-01-13	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN 325MG	Ulai Health LLC	26942d32-d6e6-464d-8fc4-ffd9806d3e62	2025-01-12	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	WAL-MART STORES INC	a354b24e-0913-829f-e053-2995a90ad407	2025-01-11	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	WAL-MART STORES INC	8f221fdb-8138-c1a8-e053-2995a90a29c2	2025-01-11	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	A-S Medication Solutions	3294ba24-f198-485e-88fc-435964434b80	2025-01-09	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	32ea1230-f9ae-46b0-910e-05cd187cee34	2025-01-09	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Pioneer Life Sciences, LLC	e817bc4a-43ef-4126-b903-aabd1390cd0c	2025-01-08	Warnings	Exact identifier application number: M013
GeriCare Liquid Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceuticals, Corp	85a074da-14b7-4db5-9d47-8ad19f520721	2025-01-06	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low Dose	ASPIRIN	Meijer Distribution Inc	eb29d6be-f095-44b2-b6ed-7e4167b596f8	2025-01-02	Warnings	Exact identifier application number: M013
Headache, Circle K	ACETAMINOPHEN, CAFFEINE, ASPIRIN TABLET	Lil' Drug Store Products, Inc.	e711ff0a-2fa0-1f2a-e053-2a95a90a4e38	2024-12-31	Warnings	Exact identifier application number: M013
Extra Strength Headache, Lil Drug Store	EXTRA STRENGHT HEADACHE RELIEF- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET	Lil' Drug Store Products, Inc.	0c41deda-490b-f5d2-e063-6394a90a5047	2024-12-31	Warnings	Exact identifier application number: M013
Extra Strength Headache, Circle K	ACETAMINOPHEN/ASPIRIN/CAFFEINE TABLET	Lil' Drug Store Products, Inc.	d18e1631-de43-4b29-e053-2995a90af56d	2024-12-31	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN 500 MG, FILM-COATED TABLET	Lil' Drug Store Products, Inc.	e5f9def4-4cf5-4e06-e053-2995a90a07ea	2024-12-31	Warnings	Exact identifier application number: M013
Regular Strength Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	6158e954-32d8-4718-e053-2a91aa0a27f3	2024-12-31	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Advanced Rx Pharmacy of Tennessee, LLC	f8375029-e567-c6a5-e053-6394a90a5b67	2024-12-31	Warnings	Exact identifier application number: M013
Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Dollar General	4907056d-6013-46b1-ae86-469dc3001591	2024-12-31	Warnings	Exact identifier application number: M013
Pediacare Childrens Grape	ACETAMINOPHEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	f9d531a2-234c-4feb-8f05-212dbee83dfe	2024-12-30	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