Motrin IB

Product NDC: 29485-7938
11-digit product format: 294857938
Labeler code: 29485
Product ID: 29485-7938_e417d943-5b9e-fc28-e053-2a95a90a057d
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mechanical Servants, LLC
Application: NDA019012
Marketing category: NDA
Marketing start: 2017-02-06
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	29485-7938		D	Discontinued by firm		2026-10-05
excluded package	package	29485-7938	29485-7938-6	D	Discontinued by firm		2026-10-05

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
N019012-001	NUPRIN	IBUPROFEN	200MG	TABLET / ORAL		1984-05-18
N019012-002	NUPRIN	IBUPROFEN	200MG	TABLET / ORAL		1987-07-29
N019012-003	MOTRIN IB	IBUPROFEN	200MG	TABLET / ORAL	RLD	1990-12-17
N019012-004	MOTRIN MIGRAINE PAIN	IBUPROFEN	200MG	TABLET / ORAL		2000-02-25

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	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
Carnauba Wax	INACTIVE INGREDIENT	R12CBM0EIZ	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
Shellac	INACTIVE INGREDIENT	46N107B71O	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29485-7938	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	10	Legacy NDC	20231207_5715910e-33be-49bd-8a1f-eeb46320e28d.zip

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Motrin IB	IBUPROFEN	Savings Distributors LLC	56846774-8413-c306-e063-6394a90a2be8	2026-01-01	Warnings	Exact identifier application applno (NDA): 019012 application number: NDA019012
Motrin IB	IBUPROFEN	Navajo Manufacturing Company Inc.	f70c1b68-61c8-b333-e053-6294a90aadaa	2023-03-16	Warnings	Exact identifier application applno (NDA): 019012 application number: NDA019012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29485-7938-6	29485793806	3 POUCH in 1 PACKAGE (29485-7938-6) > 2 TABLET, FILM COATED in 1 POUCH	3 pouch	2017-02-07	0000-00-00	No	No	Current