Acetaminophen

Product NDC: 41163-500
11-digit product format: 411630500
Labeler code: 41163
Product ID: 41163-500_24b0d399-5710-8baf-e063-6394a90aa1a5
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: United Natural Foods, Inc. dba UNFI
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-11-01
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	41163-500	41163-500-02	D	Discontinued by firm	2026-10-16
excluded package	package	41163-500	41163-500-05	D	Discontinued by firm	2026-10-16
excluded package	package	41163-500	41163-500-17	D	Discontinued by firm	2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	41163-500-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	41163-500-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	41163-500-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	41163-500-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	41163-500-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	41163-500-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	41163-500-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	41163-500-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	41163-500-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	41163-500-17	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	41163-500-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	41163-500-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	41163-500-17	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	41163-500-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	41163-500-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	41163-500-17	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	41163-500-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	41163-500-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	41163-500-17	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	41163-500-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	41163-500-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	41163-500-17	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	41163-500-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	41163-500-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	41163-500-17	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	41163-500-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	41163-500-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	41163-500-17	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	41163-500-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	41163-500-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	41163-500-17	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	41163-500-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	41163-500-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	41163-500-17	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	41163-500-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	41163-500-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
Brand name suffix: Extra Strength
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
f3db8598-fe0e-4c53-a023-5f5f8f002cc6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41163-500-01	AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
41163-500-01	AcetaminophenExtra Strength	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	7
41163-500-02	AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
41163-500-02	AcetaminophenExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	7
41163-500-04	AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
41163-500-04	AcetaminophenExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	7
41163-500-05	AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
41163-500-05	AcetaminophenExtra Strength	250 in 1 BOTTLE, PLASTIC	TABLET, COATED	250	7
41163-500-06	AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
41163-500-06	AcetaminophenExtra Strength	500 in 1 BOTTLE, PLASTIC	TABLET, COATED	500	7
41163-500-17	AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
41163-500-17	AcetaminophenExtra Strength	150 in 1 BOTTLE, PLASTIC	TABLET, COATED	150	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41163-500-01	EA - Each	41163-500	0542addf-a02a-45b0-8a77-7783fffc3d73	1	2016-10-06
41163-500-04	EA - Each	41163-500	72c2c122-7bbb-4568-a416-72e343402b02	1	2016-06-14
41163-500-05	EA - Each	41163-500	0acacb01-4dc9-4044-a453-22324f44f441	1	2016-10-06
41163-500-06	EA - Each	41163-500	2dd86359-09a8-49cb-a882-ebe40b927df9	1	2016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SUPERVALU INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41163-500	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [UNITED NATURAL FOODS, INC. DBA UNFI]	7	Current NDC, Legacy NDC, 12 package rows	20241019_f3db8598-fe0e-4c53-a023-5f5f8f002cc6.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	f3db8598-fe0e-4c53-a023-5f5f8f002cc6	7
198440	acetaminophen 500 MG Oral Tablet	SCD	f3db8598-fe0e-4c53-a023-5f5f8f002cc6	7
198440	APAP 500 MG Oral Tablet	SY	f3db8598-fe0e-4c53-a023-5f5f8f002cc6	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
41163-500-01	41163050001	1 BOTTLE, PLASTIC in 1 CARTON (41163-500-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC	2013-11-01	0000-00-00	No	No	Current
41163-500-02	41163050002	1 in 1 CARTON					Historical
41163-500-04	41163050004	1 BOTTLE, PLASTIC in 1 CARTON (41163-500-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2013-11-01	0000-00-00	No	No	Current
41163-500-05	41163050005	1 in 1 CARTON					Historical
41163-500-06	41163050006	1 BOTTLE, PLASTIC in 1 CARTON (41163-500-06) / 500 TABLET, COATED in 1 BOTTLE, PLASTIC	2013-11-01	0000-00-00	No	No	Current
41163-500-17	41163050017	1 in 1 CARTON					Historical