Application 017463

Type: NDA
Sponsor: MCNEIL CONSUMER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	MOTRIN	IBUPROFEN	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	MOTRIN	IBUPROFEN	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	MOTRIN	IBUPROFEN	TABLET;ORAL	600MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	MOTRIN	IBUPROFEN	TABLET;ORAL	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N017463-002	MOTRIN	IBUPROFEN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-003	MOTRIN	IBUPROFEN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-004	MOTRIN	IBUPROFEN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-005	MOTRIN	IBUPROFEN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22

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 5 · 172 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	N017463-002	MOTRIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017463-003	MOTRIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017463-004	MOTRIN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017463-005	MOTRIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017463-002	MOTRIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017463-003	MOTRIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017463-004	MOTRIN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017463-005	MOTRIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017463-002	MOTRIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017463-003	MOTRIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017463-004	MOTRIN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017463-005	MOTRIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017463-002	MOTRIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017463-003	MOTRIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017463-004	MOTRIN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017463-005	MOTRIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017463-002	MOTRIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017463-003	MOTRIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017463-004	MOTRIN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017463-005	MOTRIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017463-002	MOTRIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017463-003	MOTRIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017463-004	MOTRIN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017463-005	MOTRIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017463-002	MOTRIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017463-003	MOTRIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017463-004	MOTRIN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017463-005	MOTRIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017463-002	MOTRIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017463-003	MOTRIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017463-004	MOTRIN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017463-005	MOTRIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017463-002	MOTRIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017463-003	MOTRIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017463-004	MOTRIN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017463-005	MOTRIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017463-002	MOTRIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017463-003	MOTRIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017463-004	MOTRIN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017463-005	MOTRIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22	`5bbf6a4d5a75…`

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 8 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	cb897d65-7e98-4d02-be64-0704416a0f29	2026-05-28	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Family Dollar (FAMILY WELLNESS)	5beb7c11-4ed4-4cd4-9c30-3b0c4016316f	2026-05-27	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Rite Aid Corporation	1da544eb-ed4e-4124-bea3-f827f1322270	2026-05-27	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Family Dollar (FAMILY WELLNESS)	da16b1a9-0db2-4f2f-bc85-05ea5ab26e1c	2026-05-27	Warnings	Name fallback generic name: IBUPROFEN
Motrin IB	IBUPROFEN	Select Consumer Group LLC	52c650cf-3085-7b2c-e063-6394a90a797f	2026-05-27	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	52d3e633-13a2-cdcd-e063-6394a90ac189	2026-05-27	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Rite Aid Corporation	69ca781a-202e-4579-91e6-f32a22ccc22c	2026-05-27	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Rite Aid Corporation	5883ebd4-8cf7-45f1-8c66-e87416835fcc	2026-05-27	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Rite Aid Corporation	99a76de3-166a-4902-b400-b262a4fa0ae8	2026-05-27	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	St. Mary's Medical Park Pharmacy	950c3ca7-4481-976f-e053-2995a90ad51e	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	Aurohealth LLC	7461e50d-bfa1-4627-b691-089636b979d2	2026-05-22	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CVS Pharmacy	121b13c8-0b1a-4c48-9d57-3b53a9228d34	2026-05-22	Warnings	Name fallback generic name: IBUPROFEN
Berkley and Jensen Ibuprofen	IBUPROFEN	BJWC	cda57e42-6106-46ee-82d1-479a692ee5bb	2026-05-21	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Grocery Outlet, Inc.	441d762d-9022-426a-e063-6294a90a5076	2026-05-21	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Salado Sales, Inc.	06bc4445-5c80-4dd3-b1bb-d9244f45f570	2026-05-20	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	260f5862-d65d-4c34-bf53-26ca30806a67	2026-05-19	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen childrens	IBUPROFEN	Walgreen Company	f67612e8-38f3-4d1c-889b-57995a2f9f66	2026-05-15	Warnings	Name fallback generic name: IBUPROFEN
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	085dcc1a-e4b0-4d08-9476-72275382d1a1	2026-05-15	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Meijer Distribution, Inc.	3e3a5366-535d-45fb-81af-c7d98ac20b11	2026-05-15	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	ST. MARY'S MEDICAL PARK PHARMACY	88dda062-2b9c-3632-e053-2a95a90a1431	2026-05-14	Boxed warning, Warnings, Adverse reactions	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
23105	ORIG	2009-12-04
33275	SUPPL	2007-09-11
594	SUPPL	2007-09-11
13146	SUPPL	2006-01-30
10996	SUPPL	2006-01-25