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	2026-10-20
excluded package	package	41163-500	41163-500-05	D	Discontinued by firm	2026-10-20
excluded package	package	41163-500	41163-500-17	D	Discontinued by firm	2026-10-20

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 52 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equaline Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	United Natural Foods, Inc. dba UNFI	739237a5-cc62-8ad6-e053-2991aa0a91f8	2024-12-17	Warnings	Exact identifier application number: M013
NOTTS - Muscle Aches and Pain	ACETAMINOPHEN	VIVUNT PHARMA LLC	e6741300-4573-2580-e053-2a95a90a599c	2024-12-17	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever, Caseys 4good	ACETAMINOPHEN 500MG, FILM-COATED CAPLET	Lil' Drug Store Products, Inc.	e5fc5340-c224-e02b-e053-2a95a90a5297	2024-12-16	Warnings	Exact identifier application number: M013
Pain Reliever, Caseys 4good	ACETAMINOPHEN 500 MG, TABLET	Lil' Drug Store Products, Inc.	039d2cf1-57f6-4d9d-e063-6394a90a5492	2024-12-16	Warnings	Exact identifier application number: M013
Extra Strength Headache, Caseys 4good	ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET	Lil' Drug Store Products, Inc.	0425c6a8-a3ea-24ad-e063-6294a90ae15a	2024-12-16	Warnings	Exact identifier application number: M013
Lil Drug Store Childrens Pain and Fever	ACETAMINOPHEN	Lil' Drug Store Products, Inc.	5fcd41ad-449f-4090-be19-eae4171de891	2024-12-16	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	CVS Pharmacy	b9e75551-1e50-9896-e053-2a95a90aafd4	2024-12-14	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	CVS Pharmacy	b9e5df0e-06d3-6f72-e053-2995a90a2d07	2024-12-14	Warnings	Exact identifier application number: M013
Alka-Seltzer Heartburn and Pain	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Bayer HealthCare LLC.	2928e140-c868-5bf5-e063-6394a90ab024	2024-12-13	Warnings	Exact identifier application number: M013
foster and thrive pain reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	b8ee568c-80cf-4e35-865e-35516bdab0fd	2024-12-13	Warnings	Exact identifier application number: M013
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strive Pharmaceuticals Inc.	c0de0bd2-4868-46dc-a20f-3ca02caaa26b	2024-12-11	Warnings	Exact identifier application number: M013
Rite Aid Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Rite Aid	b4797380-9cef-d640-e053-2a95a90a0665	2024-12-11	Warnings	Exact identifier application number: M013
Top Value Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICAROBONATE	Tower Laboratories Ltd	44babed8-cf38-1c12-e054-00144ff8d46c	2024-12-11	Warnings, Adverse reactions	Exact identifier application number: M013
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	b5e2300a-b77b-53cc-e053-2a95a90a7a6e	2024-12-11	Warnings	Exact identifier application number: M013
EXTRA STRENGTH Headache Relief geltabs	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strive Pharmaceuticals Inc.	b432771a-4f7d-4d39-a038-d1561d8f6708	2024-12-11	Warnings	Exact identifier application number: M013
Pain Relief Childrens	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	223ffb2b-3ee5-4118-955b-bc4fa4e8a2e6	2024-12-10	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	UNFI	e689c9e3-dd4d-c646-e053-2a95a90a4b6a	2024-12-09	Warnings	Exact identifier application number: M013
DrKids Childrens Pain and Fever	ACETAMINOPHEN 80MG/PIECE	CalmCo LLC	ff4b0528-39a0-80d5-e053-6394a90a8a83	2024-12-07	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	972f09a7-2aa1-4b1b-a6dc-2c4578a07803	2024-12-05	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	DISCOUNT DRUG MART	e6feff0a-3347-194d-e053-2a95a90acd20	2024-12-05	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