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	2026-10-21
excluded package	package	41163-500	41163-500-05	D	Discontinued by firm	2026-10-21
excluded package	package	41163-500	41163-500-17	D	Discontinued by firm	2026-10-21

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 66 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin	ASPIRIN	Wildman Business Group	cdbfcf14-8685-40a9-9778-a3b4329dc1ad	2024-07-01	Warnings	Exact identifier application number: M013
Back Pain Relief Extra Strength Doans	MAGNESIUM SALICYLATE	Wildman Business Group	2e17664f-a83f-48d1-8b2b-37f41eea65b6	2024-07-01	Warnings	Exact identifier application number: M013
Meijer Effervescent Pain Relief	ASPIRIN	Meijer Distribution Inc	17553911-e0fc-e355-e063-6394a90af7b8	2024-06-28	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	4fb4f4b2-c238-4933-b874-08def3b34a28	2024-06-26	Warnings	Exact identifier application number: M013
good neighbor pharmacy pain and fever childrens	ACETAMINOPHEN	Amerisource Bergen	ca0833ef-837b-47dc-8676-e016af96622c	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	4a030c3e-8104-4a0a-98c5-6ab469451f20	2024-06-26	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Padagis Israel Pharmaceuticals Ltd	a426dd82-b2d6-405e-b0af-cfb1310a6e19	2024-06-26	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALMART INC. (see also Equate)	7d86a03f-74f4-4b24-b6a6-8747acfe905e	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	5bcc5da9-7e64-4308-a5be-2f47a8ca774d	2024-06-25	Warnings	Exact identifier application number: M013
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	NuCare Pharmaceuticals,Inc.	9e691264-d48a-6b48-e053-2995a90a9352	2024-06-20	Warnings	Exact identifier application number: M013
Aspirin	REGULAR STRENGTH ENTERIC COATED ASPIRIN	NuCare Pharmceuticals,Inc.	a0705f4f-55cb-214a-e053-2995a90aa680	2024-06-20	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG	Lil' Drug Store Products, Inc.	ee8e0e79-4da4-101f-e053-2a95a90a30a4	2024-06-19	Warnings	Exact identifier application number: M013
Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Lil' Drug Store Products, Inc.	b3a06e4b-0b31-4e2a-8dd1-9de85760477b	2024-06-19	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Meijer Distribution Inc	43c3fe72-a4ef-48a6-bc22-a644919c0c5c	2024-06-17	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	093182a6-3ed8-5a3f-e063-6294a90a354a	2024-06-14	Warnings	Exact identifier application number: M013
ACETAMINOPHEN PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	093199be-e92a-6f60-e063-6294a90a8533	2024-06-14	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	09315a3d-bb2d-4f06-e063-6294a90a3bd3	2024-06-14	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	613bc633-0426-41a7-aea9-9ff56311b607	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	cfaf9495-e654-4dfc-ba23-d2358c3720c4	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low Dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	18ff2df8-ee65-4219-ad93-cf5090bfac2d	2024-06-13	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