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 27 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Pain and Fever	ACETAMINOPHEN	Meijer Distribution Inc	11c9712d-c3b2-49cd-9c2b-0f57190c954e	2025-07-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain and Fever Childrens	ACETAMINOPHEN	CVS Pharmacy	f6bbce1c-9790-4ca4-847f-579c594ffe0b	2025-07-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	WALGREENS	07d2e322-2465-79e5-e063-6294a90a5ea4	2025-06-30	Warnings	Name fallback generic name: ACETAMINOPHEN
Arthritis Pain	ACETAMINOPHEN	DISCOUNT DRUG MART	973bcf75-8c45-ea16-e053-2a95a90aad63	2025-06-30	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	66c0cf26-357b-4722-9100-3b86d507a8cd	2025-06-30	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense pain relief arthritis pain	ACETAMINOPHEN	ASCLEMED USA INC.	2315ec07-e5b8-4332-8bc2-4e28e88892f3	2025-06-27	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN Extra Strength	ACETAMINOPHEN	TIME CAP LABS INC	fd24d0e0-4f36-42d3-9149-2fb957690305	2025-06-25	Warnings	Name fallback generic name: ACETAMINOPHEN
8HR Arthritis Pain Relief	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc.	331f907a-0fb6-e23d-e063-6394a90a2db1	2025-06-22	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL Extra Strength	ACETAMINOPHEN	Morning Star OTC	8502ea21-937d-4b33-a3e0-ffab5dc38cd8	2025-06-19	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense childrens pain and fever	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	3777f4fb-d279-199d-e063-6394a90acf36	2025-06-13	Warnings	Name fallback generic name: ACETAMINOPHEN
topcare 8 hr arthritis pain relief	ACETAMINOPHEN	Topco Associates LLC	a82f8818-1c22-46d0-b05f-698d2395ac48	2025-06-13	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy, Inc.	6dea9e11-ff99-63c7-e053-2a91aa0a5b54	2025-06-10	Warnings	Name fallback generic name: ACETAMINOPHEN
Children Acetaminophen Oral Solution	ACETAMINOPHEN	MAJOR PHARMACEUTICALS	cfca5147-f390-40bd-8f13-c5b3b8d1c5b0	2025-06-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	CVS Pharmacy	d6c8118c-bf78-4194-9b14-8de33c3ecdb7	2025-06-06	Warnings	Name fallback generic name: ACETAMINOPHEN
fever reducing childrens	ACETAMINOPHEN	CVS Pharmacy	9d89544f-3a66-4f23-b609-381d027e0c95	2025-06-06	Warnings	Name fallback generic name: ACETAMINOPHEN
Pharbetol Regular strength	ACETAMINOPHEN	ATLANTIC BIOLOGICALS CORP.	05a91d24-b498-4ba2-a275-68b871cf62d2	2025-06-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Dolo-NeuroBion	ACETAMINOPHEN	BENARD INDUSTRIES INC	b8310770-84d1-4a6f-8e23-9974947f92f1	2025-06-04	Warnings	Name fallback generic name: ACETAMINOPHEN
8HR Muscle Aches and Pain Relief	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc.	331f4bd1-1303-cc48-e063-6394a90a74d3	2025-06-03	Warnings	Name fallback generic name: ACETAMINOPHEN
Kids Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	fb74e8f9-d72f-4681-90bd-df48364405b5	2025-06-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain and Fever Childrens	ACETAMINOPHEN	P & L Development, LLC	b815fcae-8bba-4737-ac10-29a32fb69275	2025-05-30	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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