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002	MOTRIN	IBUPROFEN	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	MOTRIN	IBUPROFEN	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	MOTRIN	IBUPROFEN	TABLET;ORAL	600MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	MOTRIN	IBUPROFEN	TABLET;ORAL	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N017463-002	MOTRIN	IBUPROFEN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-003	MOTRIN	IBUPROFEN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-004	MOTRIN	IBUPROFEN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-005	MOTRIN	IBUPROFEN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22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 38 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	5ada3dbe-af87-49db-a6b0-0a1c02111cbf	2024-03-11	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS ADVIL	IBUPROFEN	Haleon US Holdings LLC	3079d932-afb2-94fe-f4ba-a3d8b5198fce	2024-02-08	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS ADVIL	IBUPROFEN	Haleon US Holdings LLC	4eba2795-e826-480d-afdc-d62004e95f36	2024-02-08	Warnings	Name fallback generic name: IBUPROFEN
pain relief	IBUPROFEN	Meijer, Inc.	1f965703-3262-4dd1-b4f8-6341786553b1	2024-02-07	Warnings	Name fallback generic name: IBUPROFEN
signature care ibuprofen	IBUPROFEN	Safeway	95904b21-752d-48b4-a882-8d81d2384e1f	2024-02-01	Warnings	Name fallback generic name: IBUPROFEN
Childrens FLANAX ORAL	IBUPROFEN	Belmora LLC	9b9318cb-3bc7-40ca-bf8a-7495d93869b3	2024-01-30	Warnings	Name fallback generic name: IBUPROFEN
good sense ibuprofen	IBUPROFEN	A-S Medication Solutions	57af05fc-30b9-4487-9a37-fb35dac4acf7	2024-01-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	fd691a4a-8010-45e6-b3da-b26374792f24	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	HART Health	1c1374e1-890f-48ab-8f93-e84da9d5bf84	2024-01-25	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	e90c573d-eb0f-45a5-94d1-efdd3d2b7a11	2024-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
infants ibuprofen	IBUPROFEN	Walgreen Company	2e408fb8-dfcd-4a39-acfa-cbbd4e88b80b	2024-01-09	Warnings	Name fallback generic name: IBUPROFEN
dg health ibuprofen	IBUPROFEN	Dolgencorp Inc	98492b9f-8f48-42dd-b026-c37dcdc5f888	2024-01-08	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN CA	IBUPROFEN	TARGET CORPORATION	8e8684fa-095e-c6d6-e053-2a95a90a15b4	2024-01-03	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e86ae68-7687-79d6-e053-2995a90ac274	2024-01-03	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e8646fe-fd62-1662-e053-2a95a90a3008	2024-01-03	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e872c8d-28e2-cd49-e053-2995a90a469f	2024-01-03	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN 200 MG	IBUPROFEN	Basic Drugs, Inc.	d3351d44-2078-3adc-e053-2995a90a3c8f	2024-01-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	59f14d2b-f48a-4c25-bea3-3dc9100898b2	2023-12-31	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen Pain Releiver/ Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	ee241be0-35f8-4789-a71f-98de31d6a590	2023-12-31	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen (NSAID) Pain Releiver/ Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	a8c6bc4e-1e48-4613-8cbf-8c5cd9d51ad0	2023-12-31	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
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