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 36 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Extra Strength	ACETAMINOPHEN	HEB	f17a18b0-a7c2-4c64-868c-460cf34e1f7d	2024-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	HEB	0863aeaa-15ec-4c67-ba79-4dad54555bd2	2024-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	American Health Packaging	3c0175a0-175b-48b8-9192-3f869690c0f2	2024-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	American Health Packaging	0d6553bd-3e18-4624-a83a-899bcafb3272	2024-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Acetaminophen Oral Suspension	ACETAMINOPHEN	American Health Packaging	8231dd91-e9e6-4350-a485-fa95d65a6d25	2024-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	KROGER COMPANY	cf63c372-acdd-6e6e-e053-2995a90a1662	2024-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense pain relief	ACETAMINOPHEN	L. Perrigo Company	8b56bfc0-2253-458d-99a6-0b0f9ae0ba50	2024-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	KROGER COMPANY	b9b63c38-83e7-62d2-e053-2a95a90a5526	2024-10-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	GoodSense	da4339c0-1822-41d8-8c20-214c379a5aa7	2024-10-18	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Regular Strength	ACETAMINOPHEN	AmeriSource Bergen	d571f520-a56e-4f7f-9214-d89197f742b6	2024-10-18	Warnings	Name fallback generic name: ACETAMINOPHEN
dg health pain relief	ACETAMINOPHEN	Dolgencorp Inc	2e1470f5-e88f-4d1d-a308-170f7080387e	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	146c735b-5081-4de4-9025-d939d560bbba	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Regular Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	1462b308-a6a5-49ca-ab29-cacbf62caf0b	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	f3db8598-fe0e-4c53-a023-5f5f8f002cc6	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Gelcaps Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	3588a3ef-a493-43ed-96e0-c259f0d087db	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	a2186895-944b-48cb-b3c2-eac208866c34	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Regular Strength	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	6a5d43c8-f4b7-4447-b2e1-53eb12208ef0	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Rising Pharma Holdings, Inc.	319ede76-110e-4902-a931-39a6d3b8c731	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	FSA Store Inc.	ec6add55-f4a3-7818-e053-2a95a90aee04	2024-10-16	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