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 78 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Reliever	ACETAMINOPHEN	WALGREENS	f3c69974-7f51-2227-e053-2995a90a5570	2023-10-21	Warnings	Exact identifier application number: M013
Menstrual Complete	MENSTRUAL COMPLETE	Healthlife of USA	c7e89b01-a8eb-4487-8f0b-a4b9ae6d9f33	2023-10-21	Warnings	Exact identifier application number: M013
Extra Strength Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	e65dbd01-2d5e-4067-ad98-98d879cfb5ee	2023-10-19	Warnings	Exact identifier application number: M013
Regular Strength Pain Reliever	ACETAMINOPHEN	INGLES MARKETS, INC.	f06fe167-8a16-14d9-e053-2a95a90a1a0f	2023-10-17	Warnings	Exact identifier application number: M013
Childrens Chewable Acetaminophen	ACETAMINOPHEN	BLESSINGS INTERNATIONAL	ee8ba190-2c42-7ca2-e053-2a95a90a01a0	2023-10-17	Warnings	Exact identifier application number: M013
Aphen	ACETAMINOPHEN	Asclemed USA, Inc.	fe3c0a2b-316b-4620-b6bc-378dbaf7ed57	2023-10-16	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Walgreens	b4b06d32-6a09-4c43-980b-377b617ba739	2023-10-09	Warnings	Exact identifier application number: M013
FLO PMS Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	O Positiv, Inc.	cce62d9f-adb1-4473-8258-910dff6b1378	2023-10-09	Warnings	Exact identifier application number: M013
childrens mapap	ACETAMINOPHEN	Proficient Rx LP	88c4183a-3032-46de-bf18-f700055f617b	2023-10-01	Warnings	Exact identifier application number: M013
Tri-Buffered Aspirin	ASPIRIN	Proficient Rx LP	640c3311-2abf-40b2-82b9-9fe4d8c1cf1d	2023-10-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY, INC	852e70e2-7279-6f33-e053-2991aa0a8676	2023-08-28	Warnings	Exact identifier application number: M013
Children Pain Relief	CHILDREN PAIN RELIEF	Allegiant Health	44c90cbe-8ece-4dd8-9ea5-7f8d6f4c0096	2023-07-17	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	Better Living Brands LLC	4a76e898-3204-4f77-bc67-c19f5fe829f3	2023-07-05	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Lodaat LLC	04017bc9-602a-4204-96a9-b7f9713155f6	2023-01-31	Warnings	Exact identifier application number: M013
Aspirin 325 mg	ASPIRIN	WALGREENS	d71a22e8-9e39-a672-e053-2a95a90a1403	2022-07-08	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	PAIN RELIEF	Allegiant Health	d41d2319-8eed-4df9-813c-313497ceb8b4	2021-11-23	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	PAIN RELIEF PM	Allegiant Health	4c9969be-a01f-4ca4-800a-e404229ce28b	2021-11-23	Warnings	Exact identifier application number: M013
Tension Headache Relief	TENSION HEADACHE RELIEF	Allegiant Health	9d348550-060b-410f-8c1e-8f43d00b860e	2021-11-22	Warnings	Exact identifier application number: M013
Aspirin 81mg Enteric coated Low Strength Aspirin Regimen	ASPIRIN	Allegiant Health	847fd2f8-2e32-4ef2-a793-b902045110f1	2021-11-19	Warnings	Exact identifier application number: M013
Aspirin 81mg Enteric coated Delayed Release	ASPIRIN	Allegiant Health	d6c7c8c9-b997-4acc-a066-133bfb1239cb	2021-11-02	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