Motrin IB

Product NDC: 66715-9812
Requested package NDC: 66715-9812-1
11-digit product format: 667159812
Labeler code: 66715
Product ID: 66715-9812_459bde25-f542-9aa4-e063-6394a90a6cb1
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lil' Drug Store Products, Inc.
Application: ANDA077349
Marketing category: ANDA
Marketing start: 2012-01-03
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: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	66715-9812	66715-9812-1	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 · 11 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077349-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL		RS	2005-06-21

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 2 · 43 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	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Motrin IB
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
201126	Internal RxNorm lookup
310965	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c2b99756-3e03-4d9f-9ce6-7db879afe3a1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66715-9812-1	Motrin IB	1 in 1 CARTON	TABLET, FILM COATED	1	9
66715-9812-1	Motrin IB	2 in 1 POUCH	TABLET, FILM COATED	2	9
66715-9812-2	Motrin IB	2 in 1 POUCH	TABLET, FILM COATED	2	9
66715-9812-2	Motrin IB	2 in 1 CARTON	TABLET, FILM COATED	2	9
66715-9812-3	Motrin IB	3 in 1 CARTON	TABLET, FILM COATED	3	9
66715-9812-3	Motrin IB	2 in 1 POUCH	TABLET, FILM COATED	2	9
66715-9812-7	Motrin IB	2 in 1 POUCH	TABLET, FILM COATED	2	9
66715-9812-7	Motrin IB	30 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	30	9
66715-9812-8	Motrin IB	30 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	30	9
66715-9812-8	Motrin IB	2 in 1 POUCH	TABLET, FILM COATED	2	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66715-9812	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED MOTRIN IB, CVP HEALTH (IBUPROFEN) TABLET, FILM COATED MOTRIN IB, TRAVEL BASIX (IBUPROFEN) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	8	Current NDC, Legacy NDC, 10 package rows	20241124_c2b99756-3e03-4d9f-9ce6-7db879afe3a1.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	90659e83-d989-46a5-9680-3a4f61612511	2026-09-04	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Ibuprofen	IBUPROFEN	H E B	21567c0f-abba-4a40-a0b9-5ce49b3d9648	2026-07-28	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Good Sense ibuprofen	IBUPROFEN	L. Perrigo Company	aebae4b3-18c8-4ecf-b578-1fe7cc50076b	2026-07-22	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB	IBUPROFEN	Select Consumer Group LLC	52c650cf-3085-7b2c-e063-6394a90a797f	2026-05-27	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
CareOne Ibuprofen	IBUPROFEN	American Sales Company	03cdff8a-8890-440d-82b5-54ce809f88cc	2026-02-03	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB, TRAVEL BASIX	IBUPROFEN	Lil' Drug Store Products, Inc.	c2b99756-3e03-4d9f-9ce6-7db879afe3a1	2025-12-10	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349 ndc (package): 66715-9812-1 ndc (product): 66715-9812 ndc11 (package): 66715981201
Ibuprofen	IBUPROFEN	CVS Pharmacy	93f8101c-1cf7-4cb0-9c00-c57c9f9023c8	2025-10-26	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB	IBUPROFEN	Kenvue Brands LLC	d21129f8-4d96-4e36-bc39-a534306dd77e	2025-10-03	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
leader ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	96da60f7-06a9-438a-ae59-8609fdd1587d	2025-09-25	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
ibuprofen	IBUPROFEN	Publix Super Markets Inc	c5cd3843-8d72-4850-bebe-4ac54e4f43fa	2025-08-21	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
ibuprofen 200	IBUPROFEN	Walgreen Company	49a3d51d-55d1-4b80-ab7b-35c27a937cb9	2025-07-02	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Topcare ibuprofen	IBUPROFEN	Topco Associates LLC	479a0c97-dbd9-47ad-9910-9dd4edf5136f	2025-07-02	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB	IBUPROFEN	Morning Star OTC	e69f00c4-b8ec-4a83-9eea-8cb2835ad776	2025-06-19	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
kirkland signature ibuprofen ib	IBUPROFEN	Costco Wholesale Company	2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c	2024-10-14	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
dg health ibuprofen	IBUPROFEN	Dolgencorp Inc	b514b589-d965-4a21-91b3-fab4019e9d96	2024-04-12	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	5ada3dbe-af87-49db-a6b0-0a1c02111cbf	2024-03-11	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
signature care ibuprofen	IBUPROFEN	Safeway	95904b21-752d-48b4-a882-8d81d2384e1f	2024-02-01	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Good Neighbor Pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	74b227c9-8341-44df-a763-cfeb371c0d28	2023-08-17	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Equate Ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	153bc4ac-427d-426a-9bb8-665487e4b169	2023-04-27	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB	IBUPROFEN	Jones Healthcare Group - Packaging Services, Inc	6419cc78-27d4-7713-e053-2a91aa0a5a10	2022-04-29	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310965	ibuprofen 200 MG Oral Tablet	PSN	c2b99756-3e03-4d9f-9ce6-7db879afe3a1	9
201126	Motrin IB 200 MG Oral Tablet	PSN	c2b99756-3e03-4d9f-9ce6-7db879afe3a1	9
201126	ibuprofen 200 MG Oral Tablet [Motrin]	SBD	c2b99756-3e03-4d9f-9ce6-7db879afe3a1	9
310965	ibuprofen 200 MG Oral Tablet	SCD	c2b99756-3e03-4d9f-9ce6-7db879afe3a1	9
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	c2b99756-3e03-4d9f-9ce6-7db879afe3a1	9
201126	Motrin 200 MG Oral Tablet	SY	c2b99756-3e03-4d9f-9ce6-7db879afe3a1	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66715-9812-1	66715981201	1 POUCH in 1 CARTON (66715-9812-1) > 2 TABLET, FILM COATED in 1 POUCH	1 pouch	2018-06-18	2024-07-15	No	No	Current