APINOPHEN

Product NDC: 46084-061
11-digit product format: 460840061
Labeler code: 46084
Product ID: 46084-061_5d9790ab-2120-4b04-a87c-d27e1e0640a2
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: TABLET
Route: ORAL
Labeler: A P J Laboratories Limited
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-03-01
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	46084-061		I	Inactivated by FDA	2026-10-12
excluded package	package	46084-061	46084-061-11	I	Inactivated by FDA	2026-10-12
excluded package	package	46084-061	46084-061-22	I	Inactivated by FDA	2026-10-12
excluded package	package	46084-061	46084-061-23	I	Inactivated by FDA	2026-10-12
excluded package	package	46084-061	46084-061-24	I	Inactivated by FDA	2026-10-12
excluded package	package	46084-061	46084-061-25	I	Inactivated by FDA	2026-10-12
excluded package	package	46084-061	46084-061-26	I	Inactivated by FDA	2026-10-12

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 3 · 154 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	46084-061-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-061-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-061-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-061-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-061-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-061-22	`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	46084-061-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-061-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-061-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-061-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-061-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-061-22	`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	46084-061-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-061-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-061-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-061-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-061-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-061-22	`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	46084-061-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-061-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-061-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-061-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-061-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-061-22	`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	46084-061-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-061-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-061-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-061-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-061-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-061-22	`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	46084-061-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-061-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-061-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-061-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-061-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-061-22	`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	46084-061-26	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-061-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-061-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-061-23	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-061-24	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-061-22	`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	46084-061-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-061-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-061-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-061-23	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-061-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-061-22	`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	46084-061-26	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46084-061-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46084-061-11	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
46084-061-11	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-22	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-23	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-24	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-25	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-26	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46084-061-11	APINOPHENEXTRA STRENGTH	2 in 1 BLISTER PACK	TABLET	2	2
46084-061-22	APINOPHENEXTRA STRENGTH	60 in 1 BLISTER PACK	TABLET	60	2
46084-061-23	APINOPHENEXTRA STRENGTH	120 in 1 BLISTER PACK	TABLET	120	2
46084-061-24	APINOPHENEXTRA STRENGTH	250 in 1 BLISTER PACK	TABLET	250	2
46084-061-25	APINOPHENEXTRA STRENGTH	500 in 1 BLISTER PACK	TABLET	500	2
46084-061-26	APINOPHENEXTRA STRENGTH	100 in 1 BOTTLE	TABLET	100	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46084-061	APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]	2	Legacy NDC, 6 package rows	20140103_c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d.zip

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	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d	2
198440	acetaminophen 500 MG Oral Tablet	SCD	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d	2
198440	APAP 500 MG Oral Tablet	SY	c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
46084-061-11	46084006111	2 in 1 BLISTER PACK	Historical
46084-061-22	46084006122	60 in 1 BLISTER PACK	Historical
46084-061-23	46084006123	120 in 1 BLISTER PACK	Historical
46084-061-24	46084006124	250 in 1 BLISTER PACK	Historical
46084-061-25	46084006125	500 in 1 BLISTER PACK	Historical
46084-061-26	46084006126	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
APINOPHEN EXTRA STRENGTH - A P J Laboratories Limited	A P J Laboratories Limited	2014-01-02	HUMAN OTC DRUG LABEL	2