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 39 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
signature care childrens pain relief	ACETAMINOPHEN	Safeway	fccb5aca-5707-491f-beb4-08f568919169	2024-09-06	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	TARGET CORPORATION	80da2582-1a20-e111-e053-2991aa0acf32	2024-09-03	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Acetaminohpen Adult Rapid Burst Cherry	ACETAMINOPHEN	Major Pharmaceuticals	9e7543d9-6249-45b5-b67d-c1b439423b9c	2024-08-27	Warnings	Name fallback generic name: ACETAMINOPHEN
Up and Up childrens acetaminophen	ACETAMINOPHEN	Target Corporation	9c3ba4dd-f51b-46ce-91b8-8b617c7b78da	2024-08-23	Warnings	Name fallback generic name: ACETAMINOPHEN
pain reliever	ACETAMINOPHEN	Walgreen Company	8255900a-2d58-4261-8df7-f28319883570	2024-08-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain and Fever	ACETAMINOPHEN	H E B	86a072a9-c3b8-47f7-8598-d66e3d30e762	2024-08-21	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	bb450552-728a-4675-b0a9-0fd2934f6c5e	2024-08-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Kroger Company	d965eba0-b268-41b2-8e02-5f6d769a44d7	2024-08-18	Warnings	Name fallback generic name: ACETAMINOPHEN
equate pain and fever childrens	ACETAMINOPHEN	Wal-Mart Stores Inc	ea68d735-c677-4280-a3a3-ae3eb5ff7462	2024-08-17	Warnings	Name fallback generic name: ACETAMINOPHEN
childrens pain and fever	ACETAMINOPHEN	CVS Pharmacy	fac408f0-ebb6-4c72-88ee-2ba85867859c	2024-08-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Regular Strength Pain Relief	ACETAMINOPHEN	Bryant Ranch Prepack	3f0c32b1-2c54-4ca3-9759-9e5dd9d7ad24	2024-08-14	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	6ec12573-03d6-40c1-9945-d345b401e062	2024-08-12	Warnings	Name fallback generic name: ACETAMINOPHEN
CareOne Infants Acetaminophen	ACETAMINOPHEN	American Sales Company	eacee273-abd7-4ea4-bcaa-7f74abcc9feb	2024-08-07	Warnings	Name fallback generic name: ACETAMINOPHEN
infants pain and fever	ACETAMINOPHEN	Kroger Company	7dbe284a-c0d5-4ac4-8445-611610f3c0fb	2024-08-02	Warnings	Name fallback generic name: ACETAMINOPHEN
infants pain fever	ACETAMINOPHEN	H E B	ab8ecc76-9621-4acc-b59b-fcf6cb2e52ef	2024-07-31	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	FSA STORE INC.	1cd6a3e6-1376-0b7b-e063-6394a90af3d1	2024-07-30	Warnings	Name fallback generic name: ACETAMINOPHEN
infants pain fever	ACETAMINOPHEN	H E B	1da89528-f658-4103-8041-cee4c775d73f	2024-07-30	Warnings	Name fallback generic name: ACETAMINOPHEN
8 Hour Pain Relief	ACETAMINOPHEN	AMERISOURCE BERGEN	9ab903aa-7170-460b-9527-e3df223f5f55	2024-07-24	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	92c22593-daf9-20a8-e053-2a95a90a365d	2024-07-23	Warnings	Name fallback generic name: ACETAMINOPHEN
equate pain and fever infants	ACETAMINOPHEN	Wal-Mart Stores Inc	8a152c8d-8ae0-4201-8bb9-7b22c3577415	2024-07-10	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