Motrin IB

Product NDC: 66715-9712
11-digit product format: 667159712
Labeler code: 66715
Product ID: 66715-9712_06305372-be06-4a48-88fd-81a6adbb84bb
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lil' Drug Store Products, Inc.
Application: NDA019012
Marketing category: NDA
Marketing start: 2010-05-10
Marketing end: 2021-04-27
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66715-9712		D	Discontinued by firm	2026-10-05
excluded package	package	66715-9712	66715-9712-1	D	Discontinued by firm	2026-10-05
excluded package	package	66715-9712	66715-9712-2	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66715-9712-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66715-9712-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66715-9712-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66715-9712-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66715-9712-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66715-9712-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66715-9712-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66715-9712-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66715-9712-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66715-9712-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66715-9712-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66715-9712-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66715-9712-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66715-9712-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66715-9712-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66715-9712-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66715-9712-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66715-9712-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66715-9712-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66715-9712-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66715-9712-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66715-9712-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66715-9712-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66715-9712-2	`557ba5c1ecfa…`	`9c80585c8c6e…`

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, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
shellac	INACTIVE INGREDIENT	46N107B71O	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	2

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
66715-9712-1	66715971201	1 POUCH in 1 CARTON (66715-9712-1) > 2 TABLET, FILM COATED in 1 POUCH	1 pouch	2010-05-10	2021-04-27	No	No	Current
66715-9712-2	66715971202	2 TABLET, FILM COATED in 1 CARTON (66715-9712-2)		2010-05-10	2021-04-27	No	No	Current