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 42 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	190bb2dc-92b4-4b59-a47f-a0251df8261c	2025-07-29	Warnings	Exact identifier application number: M013
Extra Strength NiteTime Pain Relief	ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLET	WALGREENS	c25c75c7-157f-1c0d-e053-2995a90a2e3c	2025-07-25	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Walmart Inc.	21ab3d58-bb0e-3e51-e063-6294a90ad415	2025-07-25	Warnings	Exact identifier application number: M013
Childrens TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	3a935584-6045-0a58-e063-6394a90a40c4	2025-07-23	Warnings	Exact identifier application number: M013
DR. SANA PAIN AND FEVER FOR Children	ACETAMINOPHEN	GADAL Laboratories, Inc	8a22a5ba-8623-4cca-8723-52b495403461	2025-07-23	Warnings	Exact identifier application number: M013
Duralgina	ACETAMINOPHEN	Menper Distributors Inc.	bb31f66c-80a9-4bdb-983b-cef5d21de5ff	2025-07-22	Warnings	Exact identifier application number: M013
Gesteira	ACETAMINOPHEN	Menper Distributors, Inc.	5a907289-564c-491b-98d5-d7f43eaaa1b2	2025-07-22	Warnings	Exact identifier application number: M013
Extra strength Acetaminophen PM	ACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MG	TIME CAP LABS INC	010c5c98-fc67-a9c3-e063-6394a90aa640	2025-07-21	Warnings	Exact identifier application number: M013
childrens pain and fever	ACETAMINOPHEN	Meijer Distribution Inc	44d50d79-6e47-429f-8cbe-6fcac4667732	2025-07-18	Warnings	Exact identifier application number: M013
ADWE Childrens Pain Fever	ACETAMINOPHEN	RARITAN PHARMACEUTICALS INC	79a3232f-0211-4c8a-acee-4f87e06ffc26	2025-07-17	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Walmart Inc.	24d191ca-a0c4-e1a8-e063-6394a90a7a2a	2025-07-16	Warnings	Exact identifier application number: M013
EXTRA STRENGTH HEADACHE RELIEF	ACETAMINOPHEN ASPIRIN CAFFEINE	WAL-MART STORES INC	d97073cd-b5d7-8c09-e053-2a95a90a8938	2025-07-16	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	BETTER LIVING BRANDS LLC.	f3005d0c-424e-0ab3-e053-2995a90a1c10	2025-07-16	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	Demoulas Super Markets, Inc	397fa6e1-37b2-8f51-e063-6394a90a7b94	2025-07-16	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	Demoulas Super Markets, Inc	39800c27-f39f-cd60-e063-6394a90acd55	2025-07-16	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	Demoulas Super Markets, Inc	397f2b63-733e-5b44-e063-6394a90a9718	2025-07-16	Warnings	Exact identifier application number: M013
EXTRA STRENGTH PAIN RELIEF	ACETAMINOPHEN, ASPIRIN, CAFFEINE	BETTER LIVING BRANDS, LLC	eb6026d5-d88a-f6b3-e053-2a95a90a5b20	2025-07-15	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Safeway	f9597abc-3f01-4b94-8078-228e0b74677e	2025-07-15	Warnings	Exact identifier application number: M013
Berkley and Jensen Pain Relief	ACETAMINOPHEN	BJWC	d3ee3341-93b8-487c-921e-2892d213efbb	2025-07-15	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	CVS Pharmacy	9e459853-5951-4ae7-88a6-85b502e9dd41	2025-07-14	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