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002	MOTRIN	IBUPROFEN	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	MOTRIN	IBUPROFEN	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	MOTRIN	IBUPROFEN	TABLET;ORAL	600MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	MOTRIN	IBUPROFEN	TABLET;ORAL	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N017463-002	MOTRIN	IBUPROFEN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-003	MOTRIN	IBUPROFEN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-004	MOTRIN	IBUPROFEN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-005	MOTRIN	IBUPROFEN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22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 21 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	894a5d14-e405-43ac-a5a2-0b4de5b28474	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	HEB	acf86f62-1d55-4281-95b7-8b2b51eb7c89	2025-09-10	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	HEB	c04ad0b4-5d8a-4861-9eaa-b2aaa7b19664	2025-09-10	Warnings	Name fallback generic name: IBUPROFEN
Green Guard Ibupro relief	IBUPROFEN	Unifirst First Aid Corporation	2923c4a3-f994-67a7-e054-00144ff8d46c	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Medique Iprin	IBUPROFEN	Unifirst First Aid Corporation	2910b50b-c8de-382b-e054-00144ff88e88	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Green Guard Ibuprofen Relief	IBUPROFEN	Unifirst First Aid	0798e401-8247-2fce-e054-00144ff8d46c	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Medique at Home Iprin	IBUPROFEN	Unifirst First Aid Corporation	b5547f33-2a81-867d-e053-2995a90aa2d0	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Medique Iprin	IBUPROFEN	Unifirst First Aid Corporation	0607edb0-1b3a-2ccd-e054-00144ff8d46c	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Direct Safety Ibuprofen	IBUPROFEN	Conney Safety Products, LLC	28d45743-d298-29db-e054-00144ff8d46c	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Unishield Ibuprofen	IBUPROFEN	Unishield	b9e2e2ba-e2ad-eace-e053-2995a90aed35	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Direct Safety Ibuprofen	IBUPROFEN	Conney Safety Products, LLC	07afce34-aaea-50a1-e054-00144ff88e88	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Uline Ibuprofen	IBUPROFEN	Uline	d7342a15-9d49-74ed-e053-2a95a90a22cc	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
McKesson Ibuprofen 200 mg	IBUPROFEN	McKesson Medical-Surgical	ca75b9fe-5bc8-ab90-e053-2995a90a52fb	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Henry Schein Ibuprofen	IBUPROFEN	Henry Schein Inc.	267c7c8a-2f3f-1f4d-e054-00144ff8d46c	2025-09-08	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen Thompson	IBUPROFEN	Thompson Safety	ccfbc048-f666-3188-e053-2995a90ae08f	2025-09-08	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Walgreen Company	37c9b887-190a-4daf-8199-f406913132f0	2025-09-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Sam's West Inc	6293a134-860d-4d12-9e4b-28490f824108	2025-09-03	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	Better Living Brands, LLC	fab39a0a-882b-bf96-e053-6294a90a2932	2025-09-02	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	WALGREEN CO.	fea3c4b2-cf96-2425-e053-6394a90ac697	2025-09-02	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	7-Eleven	af0ec23c-cefc-40a9-ab9a-03b8528d4e13	2025-09-01	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