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 30 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Major Extra Strength Acetaminophen Liquid	ACETAMINOPHEN	Major Pharmaceuticals	2f3af4dd-45d5-87b4-e063-6294a90ab3cc	2025-02-28	Warnings	Name fallback generic name: ACETAMINOPHEN
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	f9de7c2f-016b-4f40-8b5e-141ad194be97	2025-02-20	Warnings	Name fallback generic name: ACETAMINOPHEN
Genexa Acetaminophen PM Extra Strength	ACETAMINOPHEN	Genexa Inc.	d82cf6f3-a291-ca2b-e053-2a95a90a6de1	2025-02-20	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Acetaminophen	ACETAMINOPHEN	Advagen Pharma Limited	8b9456c9-a56b-4748-adb8-c66d6bf072e8	2025-02-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Genexa Childrens Acetaminophen	ACETAMINOPHEN	Genexa Inc.	d89fd9d8-d88e-3968-e053-2a95a90afc5f	2025-02-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	debfa787-7a48-48b5-94b0-612820524032	2025-02-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	b16e5dcf-b290-4ff2-a150-4b875647ec9a	2025-02-19	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	2025-02-18	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	c830320e-72ba-48ff-a4cd-250ac5650bf0	2025-02-18	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PD-Rx Pharmaceuticals, Inc.	da7d95af-6583-429d-8d04-e0424f32e9ad	2025-02-17	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	CVS HEALTH CORP	bbc48c9e-7eb8-2c67-e053-2a95a90a8552	2025-02-13	Warnings	Name fallback generic name: ACETAMINOPHEN
Dye Free Infants Pain and Fever	ACETAMINOPHEN	CVS	1fde0f7c-4b5b-ae9c-e063-6394a90afa41	2025-02-13	Warnings	Name fallback generic name: ACETAMINOPHEN
NOTTS - Extra Strength 500 mg	ACETAMINOPHEN	VIVUNT PHARMA LLC	e677f43d-b4ce-e5b0-e053-2a95a90ad67e	2025-02-12	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen pain reliever fever reducer	ACETAMINOPHEN	Padagis Israel Pharmaceuticals Ltd	b43974c3-4db9-4201-beee-b22596a2b241	2025-02-12	Warnings	Name fallback generic name: ACETAMINOPHEN
EXTRA STRENGTH ACETAMINOPHEN	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	c9f80d24-bd05-e1ce-e053-2995a90aa646	2025-02-10	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	TIME CAP LABS INC	c193dbc0-cc80-4a7c-aa29-457a20edf835	2025-02-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	BETTER LIVING BRANDS LLC.	f3008928-c555-64ad-e053-2995a90a7307	2025-02-05	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense pain relief	ACETAMINOPHEN	Bryant Ranch Prepack	c226205d-7c3c-49af-b3e2-fc7b09ad7857	2025-02-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Dye Free Childrens Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	a69fca9d-c0a0-4321-bf03-5c8e99cc07cc	2025-02-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever Extra Strength	ACETAMINOPHEN	Walgreen Company	28e275fb-d615-4725-998c-946fe1bfdc0c	2025-01-29	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