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002	MOTRIN	IBUPROFEN	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	MOTRIN	IBUPROFEN	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	MOTRIN	IBUPROFEN	TABLET;ORAL	600MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	MOTRIN	IBUPROFEN	TABLET;ORAL	800MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N017463-002	MOTRIN	IBUPROFEN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-003	MOTRIN	IBUPROFEN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-004	MOTRIN	IBUPROFEN	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017463-005	MOTRIN	IBUPROFEN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-05-22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 31 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen infants Drops	IBUPROFEN	Harris Teeter, LLC	2c39a24f-4e42-d75f-e063-6394a90a60fa	2025-02-04	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	fae53f7b-3948-2566-e053-6394a90aae36	2025-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Harris Teeter, LLC	2bb186c8-f791-5f1f-e063-6294a90a87ff	2025-02-04	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	0bee69ff-cf76-175e-e063-6294a90a42f6	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bi-Mart	7ceacd63-d5fa-4cab-b8f3-a5131c97bb90	2025-02-01	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	BI-MART	34440532-03e1-4feb-b3e2-dab869edeb15	2025-02-01	Warnings	Name fallback generic name: IBUPROFEN
Dye Free Childrens Ibuprofen	IBUPROFEN	PAI Holdings, LLC dba PAI Pharma	a616a7cd-4814-478e-8c58-7fbc2454d992	2025-01-31	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	2457c045-0b7c-48f4-9422-11623f13d8f1	2025-01-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PLD Acquisitions LLC DBA Avma Pharma Solutions	c6dcc329-bab5-41ab-94e7-625e07628fd6	2025-01-28	Warnings	Name fallback generic name: IBUPROFEN
Advil	IBUPROFEN	Lil' Drug Store Products, Inc.	772360bd-8631-4d24-b4db-5a7e6e1d9a13	2025-01-27	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	efb728f2-fe74-4833-8f0c-710d833abf6e	2025-01-27	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Direct Rx	d88d0544-57a7-4a82-e053-2a95a90a1945	2025-01-21		Name fallback generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension, Dye Free	IBUPROFEN	Best Choice	55fd05c7-b902-4c82-ab9a-8054d880dfbd	2025-01-20	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	DIRECT RX	c3f30813-0848-6e8a-e053-2995a90a3dea	2025-01-20		Name fallback generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension, Bubble Gum	IBUPROFEN	Best Choice	d27ca801-d4d3-4fd0-a22b-db5ada5fcb9f	2025-01-20	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension	IBUPROFEN	Reliable 1 Laboratories LLC	28dd9baa-43bd-b60a-e063-6394a90a8cf7	2025-01-15	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb	2025-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	701ee488-c57f-a82c-e053-2991aa0af403	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	19d3af1c-9dd5-48d9-bd5c-05cc8745e836	2025-01-04	Warnings	Name fallback generic name: IBUPROFEN
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	7cd838e1-85da-4510-86f0-9d8bc913e810	2025-01-03	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