Acetaminophen

Product NDC: 0363-9798
11-digit product format: 003639798
Labeler code: 0363
Product ID: 0363-9798_465347f3-6acd-a551-e063-6394a90a8729
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: WALGREEN CO.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-09-24
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
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: Acetaminophen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1

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
198440	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
b375de90-25c7-aa55-e053-2995a90a3cf8	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0363-9798-05	2023-03-01	Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
0363-9798-24	2023-03-01	Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
0363-9798-05	2023-01-30	Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
0363-9798-24	2023-01-30	Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-9798-05	Acetaminophen	50 in 1 BOTTLE	TABLET	50	12
0363-9798-10	Acetaminophen	100 in 1 BOTTLE	TABLET	100	12
0363-9798-15	Acetaminophen	150 in 1 BOTTLE	TABLET	150	12
0363-9798-21	Acetaminophen	225 in 1 BOTTLE	TABLET	225	12
0363-9798-24	Acetaminophen	24 in 1 BOTTLE	TABLET	24	12
0363-9798-37	Acetaminophen	375 in 1 BOTTLE	TABLET	375	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-9798	ACETAMINOPHEN TABLET [WALGREEN CO.]	11	Current NDC, Legacy NDC, 6 package rows	20241220_b375de90-25c7-aa55-e053-2995a90a3cf8.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 15 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin 81 mg Low Dose	ASPIRIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	23b29044-6389-42ea-839a-5351557a6ce3	2026-04-23	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4a70867e-481d-4f01-9da3-d85663a1672e	2026-04-23	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	United Natural Foods, Inc. dba UNFI	07edcb31-d31d-4607-98c3-dcb1e062cc70	2026-04-22	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Cardinal Health 107, LLC	ee50c5ee-1a61-4efc-aca9-42d897d6a3b8	2026-04-22	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	CVS PHARMACY	904a2b21-d911-40c3-9e4b-59543ea5be4f	2026-04-22	Warnings	Exact identifier application number: M013
Pamprin Multi-Symptom Maximum Strength	ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE	Focus Consumer Healthcare, LLC	60b3286d-5698-df50-e053-2991aa0afbe2	2026-04-20	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	CVS PHARMACY	af6fe4a9-2d18-4fed-b952-0a7866f65251	2026-04-20	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	Preferred Pharmaceuticals Inc.	ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e	2026-04-20	Warnings	Exact identifier application number: M013
Parry-500mg Acetaminophen	ACETAMINOPHEN	MDC PHARMACEUTICALS LIMITED	fb07ba10-3210-41bc-9310-c952118fdcf3	2026-04-17	Warnings	Exact identifier application number: M013
Aspirin NSAID	ASPIRIN	Valu Merchandisers Company	0cc46a81-54c9-44b7-b384-79d25255eff2	2026-04-17	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Valu Merchandisers Company	99de2c41-59b0-42e7-847e-e51229c6164f	2026-04-17	Warnings	Exact identifier application number: M013
Pain and Fever Childrens	ACETAMINOPHEN	Walgreen Company	1f3e2895-5ef7-4e6a-8d2e-b805d148f980	2026-04-16	Warnings	Exact identifier application number: M013
Childrens TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	b297aff8-a08b-4d37-b168-800a56564cbd	2026-04-16	Warnings	Exact identifier application number: M013
Childrens Tylenol	ACETAMINOPHEN	Kenvue Brands LLC	9782fe86-d72a-4231-b1ba-d3f3b4ee49e3	2026-04-16	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	8e65478b-7a7b-416c-b8e3-23dad79f8cc1	2026-04-16	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	Valu Merchandisers Company	c9e384e5-fa9b-4c75-b5e3-16eb8db662ef	2026-04-16	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	b6abfbbb-9826-4cd6-940f-3a314480a5a5	2026-04-15	Warnings	Exact identifier application number: M013
Good Sense Pain and Fever	ACETAMINOPHEN	L. Perrigo Company	f7137fe6-582e-43a4-8302-90ca54cd1de3	2026-04-14	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Cardinal Health 107, LLC	e13656eb-513e-411e-bdae-35ff1ba7cfc1	2026-04-13	Warnings	Exact identifier application number: M013
CareOne Acetaminophen	ACETAMINOPHEN	American Sales Company	b4f54465-3232-4685-9570-90be00876577	2026-04-12	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
198440	acetaminophen 500 MG Oral Tablet	PSN	b375de90-25c7-aa55-e053-2995a90a3cf8	12
198440	acetaminophen 500 MG Oral Tablet	SCD	b375de90-25c7-aa55-e053-2995a90a3cf8	12
198440	APAP 500 MG Oral Tablet	SY	b375de90-25c7-aa55-e053-2995a90a3cf8	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-9798-05	00363979805	50 TABLET in 1 BOTTLE (0363-9798-05)	50 tablet	2021-09-24	0000-00-00	No	No	Current
0363-9798-10	00363979810	100 TABLET in 1 BOTTLE (0363-9798-10)	100 tablet	2021-09-24	0000-00-00	No	No	Current
0363-9798-15	00363979815	150 TABLET in 1 BOTTLE (0363-9798-15)	150 tablet	2022-09-24		No	No	Current
0363-9798-21	00363979821	225 TABLET in 1 BOTTLE (0363-9798-21)	225 tablet	2022-07-01		No	No	Current
0363-9798-24	00363979824	24 TABLET in 1 BOTTLE (0363-9798-24)	24 tablet	2021-09-24	0000-00-00	No	No	Current
0363-9798-37	00363979837	375 TABLET in 1 BOTTLE (0363-9798-37)	375 tablet	2022-06-25		No	No	Current