Application 072237

Type: ANDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACEPHEN	ACETAMINOPHEN	SUPPOSITORY;RECTAL	650MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A072237-001	ACEPHEN	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL			1992-03-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`f41ea6bd6efb…`

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 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense pain relief arthritis pain	ACETAMINOPHEN	Bryant Ranch Prepack	7b0b07f6-242a-4e1a-ab39-84f0334d4716	2025-08-26	Warnings	Name fallback generic name: ACETAMINOPHEN
Topcare Pain Relief	ACETAMINOPHEN	Sixarp, LLC	2e20be17-2b6c-1a07-e063-6394a90acdd3	2025-08-25	Warnings	Name fallback generic name: ACETAMINOPHEN
pain relief	ACETAMINOPHEN	Publix Super Markets Inc	6b691dc1-09e4-46d3-b199-8917e42848a6	2025-08-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	P & L Development, LLC	59eb14a5-40b0-4331-beb5-7166e6cdf411	2025-08-18	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	caf5daea-409e-5dd2-e053-2995a90acb12	2025-08-18	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Hikma Pharmaceuticals USA Inc.	88c29438-3648-4b09-bd43-70ad7a35bcb5	2025-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACETAMINOPHEN
Dr Simi Pain Relief 100	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c42e48d-cdb2-eb74-e063-6394a90a2940	2025-08-13	Warnings	Name fallback generic name: ACETAMINOPHEN
Dr Simi Pain Relief	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c477d33-a8c2-d39f-e063-6294a90ac5f0	2025-08-13	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	3bb7dc60-97b2-1291-e063-6294a90a26d9	2025-08-12	Warnings	Name fallback generic name: ACETAMINOPHEN
Arthritis Pain	ACETAMINOPHEN	SAM'S WEST INC	3928090d-b45e-6948-e063-6394a90a47dd	2025-08-11	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense pain relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	3c1f505d-0319-a179-e063-6294a90a0b17	2025-08-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Prostat First Aid	3bdbea6a-3f11-9142-e063-6294a90a20ea	2025-08-08	Warnings	Name fallback generic name: ACETAMINOPHEN
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	3d6bf733-800c-420a-a9ab-ae4a26134799	2025-08-08	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL Regular Strength	ACETAMINOPHEN	Kenvue Brands LLC	398d8996-b522-a3cd-e063-6394a90ac2c8	2025-08-06	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Prostat First Aid	3ba313db-bafe-1947-e063-6294a90a528c	2025-08-05	Warnings	Name fallback generic name: ACETAMINOPHEN
CAREONE INFANTS ACETAMINOPHEN	ACETAMINOPHEN	Retail Business Services, LLC	b8024ec2-97c6-4aa1-b1dd-894164f48811	2025-08-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Good Sense Pain Relief	ACETAMINOPHEN	Proficient Rx LP	b4cb4a62-9ef7-4185-8770-e9a806c2fb3f	2025-08-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	36ad21a3-6229-e91b-e063-6394a90a7933	2025-07-29	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	190bb2dc-92b4-4b59-a47f-a0251df8261c	2025-07-29	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	3a935584-6045-0a58-e063-6394a90a40c4	2025-07-23	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0165	ACEPHEN	Acetaminophen	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0165	ACEPHEN	Acetaminophen	G&W Laboratories, Inc.	ANDA	Current
0713-0165	ACEPHEN	Acetaminophen	Cosette Pharmaceuticals, Inc.	ANDA	Current
55154-8850	Acephen	Acetaminophen	Cardinal Health	ANDA	Current