Application 019842

Type: NDA
Sponsor: MCNEIL CONSUMER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOTRIN	IBUPROFEN	SUSPENSION;ORAL	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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
N019842-001	MOTRIN	IBUPROFEN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD	1989-09-19

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019842-001	MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD	1989-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019842-001	MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD	1989-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`f41ea6bd6efb…`

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 28 of 46 · 917 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	09621787-9a5c-4abf-9ccd-d6f8d581738f	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	42b92fd7-468c-4fb8-9ff0-31296735df4c	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	7942cc53-1268-4e5f-8db0-f0b3524bb744	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	c5eaa3a9-5aa8-46b0-8cec-639bfb327475	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
profen ib	IBUPROFEN	Publix Super Markets Inc	bee4b754-c476-4d0e-a1b4-4db8861af84a	2025-05-01	Warnings	Name fallback generic name: IBUPROFEN
Dye Free Childrens Ibuprofen	IBUPROFEN	CVS	2cf2a4de-29d3-8af5-e063-6294a90a9cee	2025-05-01	Warnings	Name fallback generic name: IBUPROFEN
good sense ibuprofen childrens	IBUPROFEN	L. Perrigo Company	6127469c-143f-4dd2-bd37-6630291fcd5a	2025-04-30	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen childrens	IBUPROFEN	CVS Pharmacy	4459298c-e0bf-4a10-b68c-6f83fefde7e9	2025-04-29	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	H E B	bbcfea51-4c57-4a2c-a0ac-2a189c5ff38a	2025-04-28	Warnings	Name fallback generic name: IBUPROFEN
DG Health Ibuprofen	IBUPROFEN	Dolgencorp Inc	0c0cf516-b3e7-474d-885c-897574365be3	2025-04-28	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen childrens	IBUPROFEN	Meijer Distribution Inc	c5e1d74d-99a3-4b3d-86c4-03f5c4c22f77	2025-04-27	Warnings	Name fallback generic name: IBUPROFEN
kirkland signature ibuprofen	IBUPROFEN	Costco Wholesale Company	65d8d650-9afc-44f7-9409-a3aa3014d4ab	2025-04-24	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	A-S Medication Solutions	504c7e5d-e721-4df8-865b-8ea17559831d	2025-04-24	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	334e40f3-6da4-ecbe-e063-6294a90a35bf	2025-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Equaline Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	5e860059-afc8-419e-9451-b1c2265f5ce6	2025-04-18	Warnings	Name fallback generic name: IBUPROFEN
Leader Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	a5701486-0a5f-4645-91ef-1fbf525c84dd	2025-04-18	Warnings	Name fallback generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	Meijer Distribution Inc	02681a10-eb8a-457f-8aff-12e6f29079de	2025-04-18	Warnings	Name fallback generic name: IBUPROFEN
Good Neighbor Pharmacy ibuprofen childrens	IBUPROFEN	Amerisource Bergen	43b8e61b-3ac4-4a41-b682-67d08b212cc6	2025-04-18	Warnings	Name fallback generic name: IBUPROFEN
Good Sense Ibuprofen	IBUPROFEN	L. Perrigo Company	1a6b42be-c0c2-48f8-9ba3-22d1f0c0b18d	2025-04-18	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Allegiant Health	2ea039d6-f522-4103-a1f9-5b80a3b12a27	2025-04-14	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
34014	SUPPL	2007-09-11
19290	SUPPL	2007-09-11
20391	SUPPL	2006-05-08
19289	SUPPL	2006-01-30
11765	SUPPL	2006-01-25