Application 072344

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	325MG	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
A072344-001	ACEPHEN	ACETAMINOPHEN	325MG	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	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072344-001	ACEPHEN	325MG	SUPPOSITORY / RECTAL	1992-03-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072344-001	ACEPHEN	325MG	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 4 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KinderFarms Infants Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	5468b149-8fac-8d6a-e063-6294a90a8c51	2026-07-29	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY	258975d2-d8e8-407d-9804-df3b37a184e4	2026-07-29	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	f818996c-36d2-4d3d-af3e-39949157edb9	2026-07-28	Warnings	Name fallback generic name: ACETAMINOPHEN
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	2143cc16-86db-4060-96da-5c228ae9207b	2026-07-24	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Softgel Healthcare Pvt Ltd	352bb451-ffdc-411a-e063-6294a90a8cf5	2026-07-24	Warnings	Name fallback generic name: ACETAMINOPHEN
Feverall Infants	ACETAMINOPHEN	Sun Pharmaceutical Industries, Inc.	3ade895b-5dca-4d81-9415-8091923162ff	2026-07-24	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	fdb7331a-d029-8b2a-e053-6294a90adfcd	2026-07-24	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	5ada044e-50e8-4874-ac04-df5f1f9e735d	2026-07-24	Warnings	Name fallback generic name: ACETAMINOPHEN
childrens fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	a63727c3-64d8-4ae9-8da3-974cae6beed2	2026-07-24	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	e4a2566e-48ec-4602-87e3-143398d15f33	2026-07-24	Warnings	Name fallback generic name: ACETAMINOPHEN
infants fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	920e7055-7ed1-4db4-9215-f8933078bb7b	2026-07-24	Warnings	Name fallback generic name: ACETAMINOPHEN
Dye Free Pain and Fever Childrens	ACETAMINOPHEN	Walgreens	c6665c11-9a01-4472-a444-acadb1de0b69	2026-07-23	Warnings	Name fallback generic name: ACETAMINOPHEN
Tylenol Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	103d109d-f520-409c-8da2-eb6b0fbec891	2026-07-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Vicks PainQuil PAIN RELIEVER	ACETAMINOPHEN	The Procter & Gamble Manufacturing Company	0ad7b313-5d72-4cc0-97f0-1a30770350af	2026-07-22	Warnings	Name fallback generic name: ACETAMINOPHEN
GOOD SENSE INFANTS PAIN AND FEVER	ACETAMINOPHEN	L. Perrigo Company	a7cc3964-e8fa-41da-89ca-b0d2aa80f2a7	2026-07-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Acetaminophen	ACETAMINOPHEN	Cardinal Health 107, LLC	7562f4e4-54fa-488c-a199-48ad2632e2a1	2026-07-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Medline	ACETAMINOPHEN	Medline Industries, LP	4b1d7243-b943-4e2b-e063-6294a90a2c4e	2026-07-20	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc.	7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d	2026-07-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Rapidol 500 Extra Strength	ACETAMINOPHEN	Pharmadel LLC	1d9fa7ec-a509-28b2-e063-6294a90a7831	2026-07-16	Warnings	Name fallback generic name: ACETAMINOPHEN
equate pain relief	ACETAMINOPHEN	WALMART INC.	2f9b2550-5476-49ae-b741-54416a40bc29	2026-07-16	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
0713-0164	ACEPHEN	Acetaminophen	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0164	ACEPHEN	Acetaminophen	G&W Laboratories, Inc.	ANDA	Current
68788-8934	ACEPHEN	Acetaminophen	Preferred Pharmaceuticals Inc.	ANDA	Current
76413-302	ACEPHEN	Acetaminophen	Central Texas Community Health Centers	ANDA	Current