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OFIRMEV	ACETAMINOPHEN	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02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N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`84e616aacf4f…`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 9 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	f7e6e984-f0c3-ed40-e053-6294a90a89f7	2026-05-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Genexa Infants Pain and Fever	ACETAMINOPHEN	Genexa Inc.	c59cbf0e-1381-4dd2-e053-2a95a90a853a	2026-05-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Genexa Acetaminophen Extra Strength	ACETAMINOPHEN	Genexa Inc.	d6f968ca-719f-5a68-e053-2995a90a4afa	2026-05-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	a7bd0b92-6f85-6175-e053-2995a90ab837	2026-05-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	816b65d7-e53f-44c4-a418-074279d4b2af	2026-05-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Acetaminophen	ACETAMINOPHEN	Pinnacle RX LLC	513cf0e1-6874-9402-e063-6294a90aedc6	2026-05-07	Warnings	Name fallback generic name: ACETAMINOPHEN
Infants Pain and Fever Cherry Flavor	ACETAMINOPHEN	Genexa Inc.	19215ea7-d55f-8d81-e063-6294a90a4924	2026-05-07	Warnings	Name fallback generic name: ACETAMINOPHEN
up and up acetaminophen infants	ACETAMINOPHEN	Target Corporation	c1dd8330-fb6b-4d1f-9484-c199dc69214d	2026-05-07	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	HHH Pharmaceuticals	0c66b05d-132d-4c79-abfe-415fd68bbb9c	2026-05-06	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	ARMY AND AIR FORCE EXCHANGE SERVICE	f3feca65-adc1-469f-bef6-12c860599abe	2026-05-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Strategic Sourcing Services LLC	4dda3534-4e83-447b-be75-33dadce06c47	2026-05-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Tylenol Extra Strength	ACETAMINOPHEN	Savings Distributors LLC	8ed90757-833e-f4d9-e053-2995a90a29db	2026-05-01	Warnings	Name fallback generic name: ACETAMINOPHEN
EQUATE MENSTRUAL PAIN RELIEF	ACETAMINOPHEN	WALMART INC.	e387ae77-27e9-455a-b708-43288411b2c1	2026-04-29	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Camber Pharmaceuticals, Inc.	1c8fef8f-2ff5-4bea-bccb-90c2c8544c21	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACETAMINOPHEN
Extra Strength Acetaminophen	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	48912649-9fa1-a11f-e063-6294a90a8a72	2026-04-23	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4a70867e-481d-4f01-9da3-d85663a1672e	2026-04-23	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Cardinal Health 107, LLC	ee50c5ee-1a61-4efc-aca9-42d897d6a3b8	2026-04-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Better Living Brands, LLC	de3d9840-4ada-5c9a-e053-2a95a90a5721	2026-04-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	CVS PHARMACY	af6fe4a9-2d18-4fed-b952-0a7866f65251	2026-04-20	Warnings	Name fallback generic name: ACETAMINOPHEN
Parry-500mg Acetaminophen	ACETAMINOPHEN	MDC PHARMACEUTICALS LIMITED	fb07ba10-3210-41bc-9310-c952118fdcf3	2026-04-17	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