Application 072218

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	120MG	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
A072218-001	ACEPHEN	ACETAMINOPHEN	120MG	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	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072218-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	1992-03-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072218-001	ACEPHEN	120MG	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 21 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TYLENOL EXTRA STRENGTH	ACETAMINOPHEN	R J General Corporation	99e45e83-37a3-44df-9a2a-98ba7457a5bb	2025-11-17	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL PM EXTRA STRENGTH	ACETAMINOPHEN	R J General Corporation	a40ea0e3-d666-4605-b5e0-beeaf8f586f2	2025-11-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever Extra Strength	ACETAMINOPHEN	L.N.K. International, Inc.	72babe91-2586-4f05-ae90-6debfd23aa5d	2025-11-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Walgreen Company	a482e715-bec0-44a4-bb0e-ea5f5fda558e	2025-11-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Good Sense Pain Relief	ACETAMINOPHEN	L. Perrigo Company	7f78028a-484b-48b3-a37a-1e0b055bbefc	2025-11-13	Warnings	Name fallback generic name: ACETAMINOPHEN
OneSsip Acetaminophen	ACETAMINOPHEN	MEDWISE LIFESCIENCES INC.	3f88de0f-6cf6-3580-e063-6294a90abcb4	2025-11-12	Warnings	Name fallback generic name: ACETAMINOPHEN
Good Neighbor Pharmacy Pain Relief	ACETAMINOPHEN	Amerisource Bergen	4b829607-f5fb-427f-83b5-5b6b9c44ebeb	2025-11-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Leader 8HR Arthritis Pain Relief	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	2b28e5aa-da4b-4fee-ad49-e5fd6f1c65f6	2025-11-10	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	Shield Pharmaceuticals Corp	61e50135-a7c2-4a86-8a1a-d47b41d3f9d1	2025-11-07	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Chewables	ACETAMINOPHEN	Strategic Sourcing Services LLC	af2cbbaf-9b73-440a-bc88-a790cafccc6b	2025-11-07	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	42321456-d7dd-3b51-e063-6394a90ac292	2025-11-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain Relief	ACETAMINOPHEN	Family Dollar Services Inc	76058eb3-2d3f-4414-87df-7167cd27d26b	2025-11-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Children Pain and Fever Reliver	ACETAMINOPHEN	Target Corporation	1116f808-f61e-47ec-b0d0-d4be5aa905be	2025-11-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever Dye Free	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	42c4f0b2-6483-0f3c-e063-6294a90a140f	2025-11-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	HYVEE INC	3e50b3f6-1e1a-41b9-e063-6394a90abe36	2025-11-03	Warnings	Name fallback generic name: ACETAMINOPHEN
Good Sense Pain Relief	ACETAMINOPHEN	L. Perrigo Company	447de441-7d28-4415-81c5-4fc05622dd05	2025-11-03	Warnings	Name fallback generic name: ACETAMINOPHEN
Children Acetaminophen Oral Solution	ACETAMINOPHEN	VERITYRX. LLC	42a17f54-7851-84fb-e063-6394a90a9ec1	2025-11-02	Warnings	Name fallback generic name: ACETAMINOPHEN
M-PAP	ACETAMINOPHEN	VERITYRX, LLC	42a1a128-a2dd-bbc9-e063-6294a90a4fe1	2025-11-02	Warnings	Name fallback generic name: ACETAMINOPHEN
PhysiciansCare Non Aspirin Extra Strength	ACETAMINOPHEN	Acme United Corporation	c7006775-bd5b-412f-963d-ce5a158216c5	2025-10-31	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	Walgreens	f7aa624b-b00c-4fd3-9965-8e4d2b3eb4ba	2025-10-31	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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