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 14 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	Kenvue Brands LLC	4961695d-72f3-533a-e063-6294a90a5a29	2026-01-27	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	NuCare Pharmaceuticals, Inc.	4965fc33-f815-d49e-e063-6394a90a119c	2026-01-27	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	H E B	99699cd6-ba7d-4db0-9f0f-0f2c1a369138	2026-01-27	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	WAL-MART STORES INC	383e104b-beb9-45f4-b546-af42fef7ccea	2026-01-26	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL Regular Strength	ACETAMINOPHEN	Kenvue Brands LLC	01f41fae-4abb-4b96-ab09-a7d3dfc286cd	2026-01-26	Warnings	Name fallback generic name: ACETAMINOPHEN
pain relief	ACETAMINOPHEN	Meijer Distribution Inc	ec4dbb71-b507-42a3-9b68-14d4b6621ec1	2026-01-23	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Pain Relief	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e	2026-01-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Tylenol Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	17cfa99d-abb2-4d77-9e0e-e77109fbb61a	2026-01-21	Warnings	Name fallback generic name: ACETAMINOPHEN
childrens mapap	ACETAMINOPHEN	Major Pharmaceuticals	a1b0ccf0-cf24-4b34-b42a-aa1cc1e57f60	2026-01-20	Warnings	Name fallback generic name: ACETAMINOPHEN
EXTRA STRENGTH ACETAMINOPHEN	ACETAMINOPHEN	WALGREENS CO.	9b756e4e-6c56-43aa-a5bc-5b649440e759	2026-01-20	Warnings	Name fallback generic name: ACETAMINOPHEN
equate pain reliever	ACETAMINOPHEN	Wal-Mart Stores Inc	d4e438c6-80dd-4531-91e6-bc4ca7a8570f	2026-01-20	Warnings	Name fallback generic name: ACETAMINOPHEN
Unishield Extra Strength Non-Aspirin	ACETAMINOPHEN	Unishield	ba0ec1eb-db85-6a7f-e053-2995a90aafe5	2026-01-19	Warnings	Name fallback generic name: ACETAMINOPHEN
pain relief	ACETAMINOPHEN	HyVee Inc	24acd62f-72b1-418a-b733-7e4888f3c0a3	2026-01-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	Cardinal Health 110, LLC. DBA Leader	dd8b13a5-07df-4cec-92c3-1a662b1e1a56	2026-01-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	WALGREENS CO.	bdb09e15-8e17-4987-99d0-bab8856a2109	2026-01-16	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen	ACETAMINOPHEN	HF Acquisition Co LLC, DBA HealthFirst	4870ff00-f727-814d-e063-6394a90a6c8e	2026-01-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PD-Rx Pharmaceuticals, Inc.	64696f65-415e-4ce1-a5b3-70662fbcb002	2026-01-12	Warnings	Name fallback generic name: ACETAMINOPHEN
Xpect Acetaminophen	ACETAMINOPHEN	Cintas Corporation	f4aed854-730e-493d-b523-122156e08dde	2026-01-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever Extra Strength	ACETAMINOPHEN	L.N.K. International, Inc.	8fed703a-9de2-4c76-a783-fcf004f9b890	2026-01-07	Warnings	Name fallback generic name: ACETAMINOPHEN
Bactimicina Childrens Pain and Fever	ACETAMINOPHEN	DLC Laboratories, Inc.	bdade270-d813-4178-b594-4951632b6839	2026-01-07	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