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002	MOTRIN	IBUPROFEN	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	MOTRIN	IBUPROFEN	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	MOTRIN	IBUPROFEN	TABLET;ORAL	600MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	MOTRIN	IBUPROFEN	TABLET;ORAL	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 44.

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N017463-002	MOTRIN	IBUPROFEN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-003	MOTRIN	IBUPROFEN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-004	MOTRIN	IBUPROFEN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-005	MOTRIN	IBUPROFEN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`

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 46 · 917 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Lidl US LLC	0ca02f8b-4413-4e7c-a67b-8c67c53e1343	2026-09-09	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	GOODSENSE	596a1007-08ea-00ec-e063-6394a90a5eb2	2026-09-09	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen childrens	IBUPROFEN	Rite Aid Corporation	c6e68886-edcb-414d-9cba-0d97772ef8b6	2026-09-09	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	2144eff0-d7ab-486d-b116-a4ff3ae2afe2	2026-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	The Kroger Co.	a7789f7f-3356-463b-9fd7-2d7f7eba2799	2026-09-08	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	90659e83-d989-46a5-9680-3a4f61612511	2026-09-04	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Direct_Rx	40071818-5bf0-095b-e063-6294a90ad58a	2026-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Chain Drug Marketing Association, Inc.	8d518a08-486a-4d11-b042-27fc1e6060c9	2026-09-03	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN Immediate Release	IBUPROFEN	Strides Pharma Inc	a5dd275f-f388-44ec-8297-74430a742d52	2026-09-02	Boxed warning, Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	0fa4cd66-66ad-4ec9-b38c-6b5840df39df	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen Immediate Release	IBUPROFEN	Strides Pharma Inc	ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b	2026-09-02	Boxed warning, Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	99730c4a-d2ee-46f5-91f4-a15cbaace40d	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	3a38add6-a114-4e18-836c-3bfc727db231	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	404df13d-4ada-4324-9eed-e21f5d5043a4	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	fef89d3f-16e1-4a76-aabd-11d6eca4be86	2026-09-01	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Gobrands, Inc. (Goodnow)	04e1b176-b74a-413e-a8e1-dd3764b9aa8b	2026-09-01	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	2572ed69-d5a7-4513-a202-aca3230e7ec5	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Infants Ibuprofen	IBUPROFEN	Walgreens	3bbbe142-a00c-404b-a116-81ad730ea130	2026-08-25	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	ba86e936-ef72-43e5-aebf-f2c788fe2266	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Safeway, Inc.	57f06daf-690d-44a7-95a5-468732949750	2026-08-19	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