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 23 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Acetaminophen	ACETAMINOPHEN	CVS Pharmacy	3d71a0aa-5e03-0bdc-e063-6294a90a6634	2025-10-02	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	Bryant Ranch Prepack	8e40f8f1-03c5-444b-8b5e-4532c3146e47	2025-10-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Cabinet Pain Reliever and Fever Reducer Refill Acetaminophen	ACETAMINOPHEN	Cabinet Health P.B.C.	2744f082-adfd-4dfc-a87d-ed8c0d84a447	2025-10-01	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN 325 MG	ACETAMINOPHEN	Proficient Rx LP	6794830a-7856-464d-84be-c8b253cf41ac	2025-10-01	Warnings	Name fallback generic name: ACETAMINOPHEN
8 hr arthritis pain	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	68e5b8a7-17ca-4a29-9f0c-7350fcf65928	2025-09-30	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen gelcaps	ACETAMINOPHEN	TARGET CORPORATION	2ea1931e-334e-a551-e063-6394a90a03b9	2025-09-29	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen	ACETAMINOPHEN	TARGET CORPORATION	8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fb	2025-09-29	Warnings	Name fallback generic name: ACETAMINOPHEN
kirkland signature acetaminophen adult extra strength	ACETAMINOPHEN	Costco Wholesale Company	a9979167-1a82-47d7-9602-2865f9bdd628	2025-09-27	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	ProPharma Distribution	3f7a6fdc-6e36-dc3e-e063-6394a90a067d	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACETAMINOPHEN
careone acetaminophen	ACETAMINOPHEN	American Sales Company	4bb696f6-a47b-4da9-9224-9aeae3e152f3	2025-09-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain Relief	ACETAMINOPHEN	Aurohealth LLC	49a740ec-8ed4-4c76-b2d0-c13651bafa5e	2025-09-18	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen	ACETAMINOPHEN	CVS Pharmacy	fc2d4367-8884-4b76-aa3e-8c35be1ace49	2025-09-18	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	ab02080a-c903-4e4a-a9f3-2b8197ed2f2b	2025-09-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	79669930-f744-4bb1-8325-b75951489b64	2025-09-17	Warnings	Name fallback generic name: ACETAMINOPHEN
childrens acetaminophen	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	f4642725-f953-4aa8-8106-f468d8220f65	2025-09-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain and Fever Childrens	ACETAMINOPHEN	Wal-Mart Stores Inc	462580aa-712d-43bb-846d-631db3e79c1d	2025-09-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain and Fever Childrens	ACETAMINOPHEN	Wal-Mart Stores Inc	1729d4b1-ca3b-4360-8328-2484f239440a	2025-09-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Arthritis Pain	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	3e9b237c-5df4-9ec5-e063-6394a90a87de	2025-09-12	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Pain Reliever	ACETAMINOPHEN	INGLES MARKETS, INC.	3e89240b-0e27-fde4-e063-6394a90a779f	2025-09-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Pain Reliever	ACETAMINOPHEN	INGLES MARKETS, INC.	10e4bbe2-a47e-ff16-e063-6294a90a56a1	2025-09-11	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