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 44.

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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2020-11-12 02:37 UTC	2020-11	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018060-001	ACEPHEN	120MG	SUPPOSITORY / RECTAL	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018060-002	ACEPHEN	650MG	SUPPOSITORY / RECTAL	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018060-003	ACEPHEN	325MG	SUPPOSITORY / RECTAL		1986-12-18	`3a93d1ddd44b…`

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 1 of 48 · 956 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
childrens fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	7f445de3-30cf-4bd8-892d-05979cd399e7	2026-09-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	Wal-Mart Stores Inc	78874258-16cc-40b5-9e15-5943eddfce94	2026-09-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain and Fever Childrens	ACETAMINOPHEN	DOLGENCORP, LLC	c637b39c-a049-43af-a582-fc242e940d85	2026-09-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever Extra Strength	ACETAMINOPHEN	Walgreen Company	f7667529-09c0-4603-8080-f236144fac36	2026-09-08	Warnings	Name fallback generic name: ACETAMINOPHEN
UP AND UP CHILDRENS ACETAMINOPHEN	ACETAMINOPHEN	Target Corporation	e2989ead-7fdc-4295-bf94-423195775670	2026-09-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	Rite Aid Corporation	d846065a-5c39-4f4b-894c-4280acaaf4fa	2026-09-08	Warnings	Name fallback generic name: ACETAMINOPHEN
DESENFRIOL-ITO PLUS	ACETAMINOPHEN	OPMX LLC	5ac41edd-e845-734d-e063-6294a90a990a	2026-09-05	Warnings	Name fallback generic name: ACETAMINOPHEN
DRX CHOICE Regular Strength	ACETAMINOPHEN	Raritan Pharmaceuticals Inc.	8bacb24a-24d0-4175-b3e0-05efb5f5d373	2026-09-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Feverall Jr. Strength	ACETAMINOPHEN	Sun Pharmaceutical Industries, Inc.	3561bbc3-53b0-4857-8b71-39e165ed95ce	2026-09-03	Warnings	Name fallback generic name: ACETAMINOPHEN
infants pain and fever	ACETAMINOPHEN	CVS Pharmacy	53b06c48-598e-41ad-ac7a-5508c195535c	2026-09-03	Warnings	Name fallback generic name: ACETAMINOPHEN
AMAZON BASIC CARE ACETAMINOPHEN	ACETAMINOPHEN	Amazon.com Services LLC	113d92bf-f6c9-cc3d-e063-6294a90af033	2026-09-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Pain Reliever	ACETAMINOPHEN	Shield Pharmaceuticals Corp.	78052120-40d8-4a3f-b72f-cc78ca76213b	2026-09-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Kroger Children Pain plus Fever chewables	ACETAMINOPHEN	KROGER COMPANY	83b5733c-70a1-4383-9729-2eb896d0149a	2026-09-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	CVS PHARMACY	64a1ebe7-af28-4b09-96e8-28fa4dcc52bd	2026-08-31	Warnings	Name fallback generic name: ACETAMINOPHEN
MAX relief junior	ACETAMINOPHEN	Akron Pharma Inc.	0e43b885-3843-4f11-9a53-02a38c228313	2026-08-31	Warnings	Name fallback generic name: ACETAMINOPHEN
Genexa Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	5a615118-33c9-1520-e063-6394a90a21a6	2026-08-31	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen extra strength	ACETAMINOPHEN	Sam's West Inc	dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d	2026-08-28	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	REMEDYREPACK INC.	464e404a-1957-44a2-a53a-f2a9d3c15bde	2026-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACETAMINOPHEN
major acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	ca9e1dae-eefb-4653-952f-2fde09059693	2026-08-27	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	FSA STORE INC.	5502ef15-9f40-db56-e063-6394a90a2de4	2026-08-26	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