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 11 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Mapap	ACETAMINOPHEN	Major Pharmaceuticals	efec6af2-8b26-47f6-88c8-b0a6d69a2d7d	2026-06-03	Warnings	Exact identifier application number: M013
Acetaminophen PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	ae3114c3-8cfe-4b81-8ac7-c281fe68b462	2026-06-03	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	COSTCO WHOLESALE CORPORATION	3745aa18-a711-43ed-9bc4-1f087b3c53c0	2026-06-03	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	3f653262-b931-7d42-e063-6394a90adddd	2026-06-03	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Walgreen Company	0b1bef50-7957-4ea1-9ae3-91f59ea2dbb4	2026-06-03	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	42310898-cf3a-4ffb-88bb-b8b84449156e	2026-06-02	Warnings	Exact identifier application number: M013
PAIN RELIEF	ACETAMINOPHEN	Meijer, Inc.	1319bab8-8f17-44fb-9d91-099b0ba38a8d	2026-06-01	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Family Dollar (FAMILY WELLNESS)	7a98d4d9-54e2-45c1-a76a-7f1907566e95	2026-06-01	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	58840cf4-aceb-c7cf-e063-6294a90a5ff4	2026-06-01	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS Pharmacy	832acd72-1dda-4490-978f-5f31748942df	2026-06-01	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	786dbcd5-f5c2-4491-e053-2991aa0a3437	2026-05-29	Warnings	Exact identifier application number: M013
Back and Body Extra Strength	ASPIRIN, CAFFEINE	Meijer Distribution Inc	e513f2d9-d591-4790-a117-6176ce2279dc	2026-05-29	Warnings	Exact identifier application number: M013
Chewable Acetaminophen Childrens	ACETAMINOPHEN	Cardinal Health 110, LLC. DBA Leader	5460a4b7-5da3-4fc2-a565-0b0dd11bbf44	2026-05-29	Warnings	Exact identifier application number: M013
Extra Strength Mini Softgels Pain Reliever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f55d3663-7007-41cd-ae2d-5aca6311be81	2026-05-28	Warnings	Exact identifier application number: M013
Genexa Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	5130c695-a80e-2dd3-e063-6294a90a404f	2026-05-28	Warnings	Exact identifier application number: M013
TYLENOL Regular Strength	ACETAMINOPHEN	Kenvue Brands LLC	1622f694-4d63-4c56-8737-fae31f0ecfb7	2026-05-27	Warnings	Exact identifier application number: M013
INFANTS Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	257436e1-e0f3-4a87-bffe-4f176b836caf	2026-05-27	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	6509a545-0036-460a-8f0d-b31caae17855	2026-05-27	Warnings	Exact identifier application number: M013
Alka-Seltzer Original	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Select Consumer Group	3ca80d74-1e8b-49d9-e063-6394a90a4312	2026-05-24	Warnings	Exact identifier application number: M013
Pain and Fever Chewables Childrens	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	bad8ac0a-518d-4639-9b92-a39e0d437238	2026-05-22	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