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001	MOTRIN	IBUPROFEN	SUSPENSION;ORAL	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 1.

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N019842-001	MOTRIN	IBUPROFEN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD	1989-09-19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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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UTC	2026-02	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`011fe1cb6892…`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of this ZIP	2025-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`31067a03dcf5…`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UTC	2025-08	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`6a471c1ec25d…`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of this ZIP	2025-03	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`fd3edfee7708…`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…`
2022-09-29 23:25 UTC	2022-09	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	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	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	`cb3db0bc1861…`

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 · 949 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen minis	IBUPROFEN	Walgreens	6d1d131d-0741-4a75-8383-9322f4f3faab	2026-08-06	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	216e5600-56b4-44b0-88b7-69adfb245802	2026-08-06	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Lidl US LLC	0ca02f8b-4413-4e7c-a67b-8c67c53e1343	2026-08-06	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	COSTCO WHOLESALE CORPORATION	4b8ad98e-de76-4f49-3b89-01e9dd5cde16	2026-08-06	Warnings	Name fallback generic name: IBUPROFEN
Dye Free Ibuprofen	IBUPROFEN	Walgreen Company	d3d093f9-207a-40d4-a7be-c6b5a544a0a7	2026-08-06	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Walgreen Company	c118b290-f821-4e73-906e-8a93edaf34e4	2026-08-05	Warnings	Name fallback generic name: IBUPROFEN
Dye Free Ibuprofen	IBUPROFEN	Walgreen Company	8944a0e8-2928-4494-915f-d1e0a6d4bf5c	2026-08-04	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	560e4e05-21e0-4b2a-ab2f-872b5dbb3901	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Chain Drug Marketing Association, Inc.	733d0b21-c177-4c60-9243-2f1e7cb5854a	2026-08-04	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Pioneer Life Sciences, LLC	8abd74a4-ad33-4c10-b677-acb469f815e6	2026-08-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Pioneer Life Sciences, LLC	291602fa-8ebe-4200-bba7-9798c90f8a50	2026-08-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NUVICARE LLC	b063d2dc-d579-46e7-8cfc-1596c803c7f9	2026-08-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NUVICARE LLC	7905edc1-2a45-4adc-a7bc-42b1ddb6ba59	2026-08-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	2572ed69-d5a7-4513-a202-aca3230e7ec5	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals LLC	17577b3b-e755-45d1-8b53-775d058578b2	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	b5a47efe-222f-4cbd-b649-caafd16a0829	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Harris Teeter	637210f0-6494-4656-8b2b-14d7476cb127	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Harris Teeter	9d5c994a-8363-4ddb-956c-e12b79a32a58	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Harris Teeter	87ffbf01-54de-45a8-b2a3-367d21927882	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Harris Teeter	14515409-736f-4119-b6a0-cb19ee2e948e	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN

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