Mapap

Product NDC: 0904-5816
11-digit product format: 009045816
Labeler code: 0904
Product ID: 0904-5816_f1145130-2aa7-4229-94ce-4118839f211a
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2004-05-10
Marketing end: 2021-11-15
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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 product	product	0904-5816		D	Discontinued by firm		2026-10-05
excluded package	package	0904-5816	0904-5816-60	D	Discontinued by firm		2026-10-05

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-5816-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-5816-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-5816-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-5816-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-5816-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-5816-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-5816-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0904-5816-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0904-5816-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0904-5816-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0904-5816-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0904-5816-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5816-51	EA - Each	0904-5816	e5c6c8bf-808d-4fac-a78b-495ccb422b27	1	2013-08-02
0904-5816-60	EA - Each	0904-5816	1407f976-228d-428c-be28-6148302a815e	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MAPAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]	8

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5816-60	00904581660	1 BOTTLE, PLASTIC in 1 CARTON (0904-5816-60) > 100 TABLET in 1 BOTTLE, PLASTIC	2004-05-10	2021-11-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major 44-519-delisted	Major Pharmaceuticals \| LNK International, Inc.	2019-03-28	HUMAN OTC DRUG LABEL	13