Application 018060

Type: NDA
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
002	ACEPHEN	ACETAMINOPHEN	SUPPOSITORY;RECTAL	650MG	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018060-001	ACEPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982
N018060-002	ACEPHEN	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982
N018060-003	ACEPHEN	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`301d65b070ca…`

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 31 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	38b839b6-de7d-4f33-a19a-efc92cdad92c	2025-01-24	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense pain relief	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	523b68da-cd2a-4960-95e7-de5d51ce33c1	2025-01-23	Warnings	Name fallback generic name: ACETAMINOPHEN
Little Remedies Childrens Fever Pain Reliever	ACETAMINOPHEN	Medtech Products Inc.	e1e44c85-d10c-4997-8f85-064cda7906eb	2025-01-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Dye Free Childrens Acetaminophen	ACETAMINOPHEN	Precision Dose Inc.	5cc698fa-0841-4851-ae21-0aac8b40eb0a	2025-01-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	RITE AID	d1f18c32-c043-7c97-e053-2a95a90a203e	2025-01-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Children Pain and Fever Reliever	ACETAMINOPHEN	Target Corporation	0dd643a4-3cbc-423d-95b4-ba373b09d895	2025-01-16	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Reliable 1 Laboratories LLC	2651bf11-4d66-43ba-e054-00144ff88e88	2025-01-15	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN 325 MG	ACETAMINOPHEN	Reliable 1 Laboratories LLC	25626b46-78f8-7226-e054-00144ff8d46c	2025-01-15	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	WAL-MART STORES INC	a354b24e-0913-829f-e053-2995a90ad407	2025-01-11	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	WAL-MART STORES INC	8f221fdb-8138-c1a8-e053-2995a90a29c2	2025-01-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	32ea1230-f9ae-46b0-910e-05cd187cee34	2025-01-09	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Pioneer Life Sciences, LLC	e817bc4a-43ef-4126-b903-aabd1390cd0c	2025-01-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Infants Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	75d47849-a404-479b-a229-1b570d800114	2025-01-08	Warnings	Name fallback generic name: ACETAMINOPHEN
GeriCare Liquid Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceuticals, Corp	85a074da-14b7-4db5-9d47-8ad19f520721	2025-01-06	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen for children	ACETAMINOPHEN	A-S Medication Solutions	a9864f73-abb2-4cb1-a692-a48efdeeedf8	2025-01-06	Warnings	Name fallback generic name: ACETAMINOPHEN
Regular Strength Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	6158e954-32d8-4718-e053-2a91aa0a27f3	2024-12-31	Warnings	Name fallback generic name: ACETAMINOPHEN
Pediacare Childrens Grape	ACETAMINOPHEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	f9d531a2-234c-4feb-8f05-212dbee83dfe	2024-12-30	Warnings	Name fallback generic name: ACETAMINOPHEN
Pediacare Childrens Acetaminophen Grape	ACETAMINOPHEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	596372c7-eca3-4527-8e22-ab0751e2526b	2024-12-30	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy	6f880abe-5284-42b0-9db6-b071444b197b	2024-12-27	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC.	1608b4f0-bf20-4024-b8f2-20a4df7a4b21	2024-12-26	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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0118	ACEPHEN	Acetaminophen	G&W Laboratories, Inc.	NDA	Current
0713-0118	ACEPHEN	Acetaminophen	Cosette Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11138	SUPPL	2014-04-16
14003	SUPPL	2014-03-27
14002	SUPPL	2011-11-03
817	SUPPL	2010-05-03
20106	SUPPL	2003-09-11