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OFIRMEV	ACETAMINOPHEN	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02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N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`84e616aacf4f…`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 19 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8 Hour Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	d11a7412-a543-0e34-e053-2995a90afd63	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	02e3798f-86d9-64b4-e063-6294a90a29de	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Regular Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	f7e87eac-59fb-4a72-b5c6-02953112be6a	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	355a094c-bed9-4959-8cf0-619f0e246105	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	fac4e0c6-684f-45a1-99f2-de4de4017cc8	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	2e30754a-42f7-4da2-944c-be61cee47b43	2025-12-10	Warnings	Name fallback generic name: ACETAMINOPHEN
MAX relief junior	ACETAMINOPHEN	ATLANTIC BIOLOGICALS CORP.	ff1f6f82-0c7c-4e3f-a2bd-3185e16fa770	2025-12-10	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	36ad34f4-4e66-f371-e063-6394a90ae76a	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	LIDL US LLC	ec543339-20ab-2cba-e053-2995a90ac740	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	c57c10fc-f182-4153-8974-ef359a5f5ac1	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Rapid Release Gelcaps Extra Strength	ACETAMINOPHEN	Safeway	c830d1ac-c4c5-4eb1-98bb-22707cb6db91	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
childrens acetaminophen	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	f65203a2-64f0-4138-97e4-6eab99194178	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN	ACETAMINOPHEN	BJWC	e27b6637-ef32-44b5-a531-b6617d02fbbf	2025-12-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	WALGREENS	3f9f1740-9e8b-6a2d-e063-6294a90a67cb	2025-12-06	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Easy Tabs Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	729132cd-f209-447a-8949-a90b5a5c01da	2025-12-05	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	Granules Pharmaceuticals Inc.	d5352861-6926-f1b0-e053-2a95a90a7d66	2025-12-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Acetaminophen	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	7a29dde6-a177-6206-e053-2991aa0a01f2	2025-12-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	7570aaa2-3238-4cd3-b788-915caa970dba	2025-12-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Midol Long Lasting Relief	ACETAMINOPHEN	Bayer HealthCare LLC.	4a3a711d-c882-3525-e054-00144ff8d46c	2025-12-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	e1a55e0d-bb86-4515-8436-51a74b403685	2025-12-02	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