Application 022450

Type: NDA
Sponsor: MALLINCKRODT HOSP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OFIRMEV	ACETAMINOPHEN	SOLUTION;INTRAVENOUS	1GM/100ML (10MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022450-001	OFIRMEV	ACETAMINOPHEN	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022450-001	10383834	2028-11-13	U-2262		2019-09-18
N022450-001	10383834	2028-11-13	U-2621		2019-09-18
N022450-001	9610265	2028-11-13	U-2263		2017-05-04
N022450-001	9987238	2028-11-13	U-2261		2018-06-13
N022450-001	10383834*PED	2029-05-13		Pediatric extension
N022450-001	9610265*PED	2029-05-13		Pediatric extension
N022450-001	9987238*PED	2029-05-13		Pediatric extension
N022450-001	9399012	2031-09-11	U-2261		2016-08-08
N022450-001	9399012	2031-09-11	U-2262		2016-08-08
N022450-001	9399012*PED	2032-03-11		Pediatric extension

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022450-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022450-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022450-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022450-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022450-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022450-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022450-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022450-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022450-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022450-001	AP	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 406 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022450-001	10383834	2028-11-13	U-2262		2019-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022450-001	10383834	2028-11-13	U-2621		2019-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022450-001	9610265	2028-11-13	U-2263		2017-05-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022450-001	9987238	2028-11-13	U-2261		2018-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022450-001	10383834*PED	2029-05-13		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022450-001	9610265*PED	2029-05-13		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022450-001	9987238*PED	2029-05-13		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022450-001	9399012	2031-09-11	U-2262		2016-08-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022450-001	9399012	2031-09-11	U-2261		2016-08-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022450-001	9399012*PED	2032-03-11		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022450-001	10383834	2028-11-13	U-2262		2019-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	10383834	2028-11-13	U-2621		2019-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9610265	2028-11-13	U-2263		2017-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9987238	2028-11-13	U-2261		2018-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	10383834*PED	2029-05-13		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9610265*PED	2029-05-13		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9987238*PED	2029-05-13		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9399012	2031-09-11	U-2262		2016-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9399012	2031-09-11	U-2261		2016-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9399012*PED	2032-03-11		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022450-001	10383834	2028-11-13	U-2262		2019-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	10383834	2028-11-13	U-2621		2019-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9610265	2028-11-13	U-2263		2017-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9987238	2028-11-13	U-2261		2018-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	10383834*PED	2029-05-13		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9610265*PED	2029-05-13		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9987238*PED	2029-05-13		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9399012	2031-09-11	U-2262		2016-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9399012	2031-09-11	U-2261		2016-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9399012*PED	2032-03-11		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	10383834	2028-11-13	U-2262		2019-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	10383834	2028-11-13	U-2621		2019-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9610265	2028-11-13	U-2263		2017-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9987238	2028-11-13	U-2261		2018-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	10383834*PED	2029-05-13		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9610265*PED	2029-05-13		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9987238*PED	2029-05-13		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9399012	2031-09-11	U-2262		2016-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9399012	2031-09-11	U-2261		2016-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9399012*PED	2032-03-11		Pediatric extension		`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022450-001	M-196	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022450-001	PED	2020-07-27	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022450-001	M-196	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022450-001	PED	2020-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022450-001	M-196	2020-01-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022450-001	PED	2020-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022450-001	M-196	2020-01-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022450-001	PED	2020-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022450-001	M-196	2020-01-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022450-001	PED	2020-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022450-001	M-196	2020-01-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022450-001	PED	2020-07-27	`ea99ee380514…`

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 6 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Reliever	ACETAMINOPHEN	Orelli Inc.	4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d	2026-06-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	DOLGENCORP, LLC	acc94a3e-21b6-4375-9881-38cf9bab8692	2026-06-19	Warnings	Name fallback generic name: ACETAMINOPHEN
dg health 8 hr arthritis pain relief	ACETAMINOPHEN	Dolgencorp Inc	fc7838a7-fc6d-41b7-b8e4-97bee2bfa6d4	2026-06-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Neo-Lubrina Children	ACETAMINOPHEN	OPMX LLC	5476f4cf-4a5d-2287-e063-6394a90a5ed5	2026-06-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Oncor Pharmaceuticals	4c396d0e-aa93-4f9e-b065-2e606f7f05cd	2026-06-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Mejoralito Children	ACETAMINOPHEN	OPMX LLC	5464188d-0137-033e-e063-6294a90ace66	2026-06-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever Relief	ACETAMINOPHEN	Chain Drug Marketing Association, Inc.	420a1e05-caa6-481f-bdab-a670f0220f96	2026-06-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	DOLGENCORP, LLC	ce9f4e0d-43fb-499a-b8a2-a997a14841c4	2026-06-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	L.N.K. International, Inc.	734cc3d2-6fc5-4dcc-93ed-0b57c1f01345	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	00eb3e4b-1507-4c9a-83a5-ef50cb312753	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	59773893-09a8-47a2-943a-e9ea9da4458a	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	Shield Pharmaceuticals Corp.	96eb7f9f-ff2d-4661-bbe6-1860aafe03f6	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Duralgina Extra Strength	ACETAMINOPHEN	Menper Distributors, Inc.	544e3d7e-a759-384f-e063-6294a90a5baa	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
DESENFRIOL-ITO PLUS	ACETAMINOPHEN	OPMX LLC	544ee7bd-0c95-2485-e063-6294a90a98c7	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
pain relief childrens	ACETAMINOPHEN	Rite Aid Corporation	be2286a1-946b-4bf5-b14c-8e86da669594	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
CHILDRENS TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	3162733b-9382-39f1-e063-6294a90ac420	2026-06-12	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	Dr. Reddy's Laboratories Inc.	9769e0c0-2f4c-3b7a-1a65-c98fbce11681	2026-06-12	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	NuCare Pharmaceuticals, Inc.	54010ddf-25d1-2016-e063-6294a90a877d	2026-06-11	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	983debdf-4a61-4dde-ba34-567fdd17720e	2026-06-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PUBLIX SUPERMARKETS, INC	3f17fa06-4932-b8ec-e063-6294a90a0381	2026-06-09	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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43825-102	Ofirmev	acetaminophen	Mallinckrodt Hospital Products Inc.	NDA	Current
43825-102	Ofirmev	acetaminophen	Mallinckrodt Hospital Pro	NDA	Current
43825-102	Ofirmev	acetaminophen	Mallinckrodt Hospital Products Inc.	NDA	Current
43825-102	Ofirmev	acetaminophen	Mallinckrodt Hospital Products Inc.	NDA	Current
43825-102	Ofirmev	acetaminophen	Mallinckrodt Hospital Products Inc.	NDA	Current
43825-102	Ofirmev	acetaminophen	Mallinckrodt Hospital Products Inc.	NDA	Current
51662-1424	OFIRMEV (ACETAMINOPHEN)	OFIRMEV (ACETAMINOPHEN)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1424	OFIRMEV (ACETAMINOPHEN)	OFIRMEV (ACETAMINOPHEN)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56011	SUPPL	2018-10-18
53659	SUPPL	2018-04-12
47039	SUPPL	2017-01-31
47028	SUPPL	2017-01-27
51143	SUPPL	2015-03-30
38718	SUPPL	2013-10-22
17595	SUPPL	2013-10-22
29736	SUPPL	2013-10-21
7404	SUPPL	2013-10-21
51137	SUPPL	2011-12-08
42530	ORIG	2011-04-04
24312	ORIG	2011-04-04
51136	SUPPL	2010-12-20
29735	ORIG	2010-11-08
38717	ORIG	2010-11-05
51132	SUPPL	2007-08-24
66976	ORIG	1900-01-01
54093	SUPPL	1900-01-01
51428	SUPPL	1900-01-01
51427	SUPPL	1900-01-01
51426	SUPPL	1900-01-01