Acetaminophen

Product NDC: 49035-175
11-digit product format: 490350175
Labeler code: 49035
Product ID: 49035-175_457f2649-8526-4144-baf1-cd1347417604
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Wal-Mart Stores Inc
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1993-04-02
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49035-175	49035-175-10	D	Discontinued by firm		2026-10-15
excluded package	package	49035-175	49035-175-96	D	Discontinued by firm		2026-10-15

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 · 24 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	49035-175-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	49035-175-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	49035-175-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	49035-175-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	49035-175-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	49035-175-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	49035-175-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	49035-175-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	49035-175-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	49035-175-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	49035-175-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	49035-175-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	49035-175-96	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	49035-175-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	49035-175-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	49035-175-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	49035-175-96	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	49035-175-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	49035-175-96	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	49035-175-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	49035-175-96	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	49035-175-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	49035-175-96	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	49035-175-10	`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: 2027-12-31

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
78874258-16cc-40b5-9e15-5943eddfce94	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49035-175-10	AcetaminophenExtra Strength	40 in 1 BOTTLE	TABLET, FILM COATED	40	17
49035-175-10	AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	17
49035-175-15	AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	17
49035-175-15	AcetaminophenExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	17
49035-175-96	AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	17
49035-175-96	AcetaminophenExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-175-12	EA - Each	49035-175	b3bf33d2-ce4d-49dc-95f1-460d430e7dfe	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WAL-MART STORES INC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WAL-MART STORES INC]	2
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WAL-MART STORES INC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WAL-MART STORES INC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WAL-MART STORES INC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WAL-MART STORES INC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WAL-MART STORES INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-175	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WAL-MART STORES INC]	15	Current NDC, Legacy NDC, 6 package rows	20240825_78874258-16cc-40b5-9e15-5943eddfce94.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 25 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Excedrin Extra Strength Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE	Select Consumer Group	3caa0a47-de83-90d2-e063-6394a90a3436	2025-12-27	Warnings	Exact identifier application number: M013
Aspirin Pain reliver	ASPIRIN	Pioneer Life Sciences, LLC	c2759844-a49c-450f-e053-2a95a90a2972	2025-12-26	Warnings	Exact identifier application number: M013
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Pioneer Life Sciences, LLC	aa2de3a5-a20d-33c6-e053-2a95a90ada3e	2025-12-26	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Discount Drug Mart	2aa0f9f3-924c-4a4a-bb5f-2a326acc2408	2025-12-26	Warnings	Exact identifier application number: M013
GenCare Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Pioneer Life Sciences, LLC	667f6f1b-5179-481c-a131-940c7937aada	2025-12-26	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN	Pharbest Pharmaceuticals, Inc.	04dbd98f-c74d-43b2-8bda-74f18be7cf6c	2025-12-24	Warnings	Exact identifier application number: M013
Adult Low Dose Aspirin Enteric Coated	ASPIRIN 81MG	Pharbest Pharmaceuticals, Inc.	45e5bae9-22a7-4699-85ea-5b922af6b96d	2025-12-24	Warnings	Exact identifier application number: M013
Aspirin 325 mg	ASPIRIN	BETTER LIVING BRANDS, LLC	424a242f-c8c6-9dd7-e063-6394a90ab4d5	2025-12-24	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Pharbest Pharmaceuticals, Inc.	2763a733-d617-4d95-8429-fbf81d9d77fb	2025-12-24	Warnings	Exact identifier application number: M013
Pharbetol Regular strength	ACETAMINOPHEN	Pharbest Pharmaceuticals, Inc.	e0a39957-d918-4125-88f9-0e550b976fa1	2025-12-24	Warnings	Exact identifier application number: M013
PHARBETOL	ACETAMINOPHEN 500MG	Pharbest Pharmaceuticals, Inc.	27337be9-e279-460e-903e-ae4463099599	2025-12-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PUBLIX SUPERMARKETS, INC	08f5af1d-365b-a97c-e063-6394a90a99ae	2025-12-23	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Pioneer Life Sciences, LLC	0d67bb52-7ae3-439e-9e47-4e21eb0ca352	2025-12-23	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Pioneer Life Sciences, LLC	11e6ec2a-5171-4496-a15f-6ff744bd1f2f	2025-12-23	Warnings	Exact identifier application number: M013
Aspirin Pain reliver	ASPIRIN	Pioneer Life Sciences, LLC	8dc29957-2ac1-47f8-89fd-a6bcf97ee3d3	2025-12-23	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc	a1255f60-b9c6-9a95-e053-2995a90a9e80	2025-12-22	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc	a51395ea-e038-dc9c-e053-2a95a90a287d	2025-12-22	Warnings	Exact identifier application number: M013
CareALL Acetaminophen	ACETAMINOPHEN	New World Imports, Inc	1148b4d9-fa6a-49e6-9663-17b2c8373846	2025-12-22	Warnings	Exact identifier application number: M013
CAREALL Aspirin	ASPIRIN	New World Imports, Inc	f4aa0de9-ffcc-4140-91a3-fd9e7a55f2ac	2025-12-22	Warnings	Exact identifier application number: M013
Vitapirena	ACETAMINOPHEN	Pharmadel LLC	0547bc1f-d000-f5a6-e063-6294a90ac73d	2025-12-22	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	78874258-16cc-40b5-9e15-5943eddfce94	17
198440	acetaminophen 500 MG Oral Tablet	SCD	78874258-16cc-40b5-9e15-5943eddfce94	17
198440	APAP 500 MG Oral Tablet	SY	78874258-16cc-40b5-9e15-5943eddfce94	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-175-10	49035017510	40 in 1 BOTTLE					Historical
49035-175-15	49035017515	1 BOTTLE, PLASTIC in 1 CARTON (49035-175-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1993-04-02	0000-00-00	No	No	Current
49035-175-96	49035017596	1 in 1 CARTON					Historical