Ibuprofen

Product NDC: 37835-581
Requested package NDC: 37835-581-25
11-digit product format: 378350581
Labeler code: 37835
Product ID: 37835-581_2eb89807-b8b2-e482-e063-6294a90aea80
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Bi-Mart
Application: ANDA079174
Marketing category: ANDA
Marketing start: 2011-01-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A079174-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2010-12-10

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
7ceacd63-d5fa-4cab-b8f3-a5131c97bb90	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
37835-581-01	Ibuprofen	100 in 1 BOTTLE	TABLET	100	1
37835-581-05	Ibuprofen	500 in 1 BOTTLE	TABLET	500	1
37835-581-10	Ibuprofen	1000 in 1 BOTTLE	TABLET	1000	1
37835-581-25	Ibuprofen	250 in 1 BOTTLE	TABLET	250	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37835-581	IBUPROFEN TABLET [BI-MART]	1	Current NDC, 4 package rows	20250226_7ceacd63-d5fa-4cab-b8f3-a5131c97bb90.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 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	Harris Teeter	9d5c994a-8363-4ddb-956c-e12b79a32a58	2026-07-29	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Harris Teeter	1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc633	2026-07-29	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	TWIN MED LLC	f03958f8-aeae-edf0-e053-2a95a90a3e9e	2026-07-22	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuwin Forte	IBUPROFEN	OPMX LLC	0daf1be9-ea38-461e-e063-6394a90a7954	2026-07-15	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Dr. Reddy's Laboratories Inc.	4d830b9b-b396-9581-7572-c7f19ff17597	2026-07-01	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	68988a5b-7a6a-4ecd-8006-f2610bac2ad7	2026-06-08	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Medline industries, LP	5d2482b4-cd90-4246-85a9-fd1d35315b6c	2026-06-04	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Grocery Outlet, Inc.	441d762d-9022-426a-e063-6294a90a5076	2026-05-21	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
IBUPROFEN 200 MG	IBUPROFEN 200 MG	Farmacias De Similares TX LLC	441f7920-5666-5a3e-e063-6294a90a5583	2026-01-28	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	HYVEE INC	45aead8a-37ee-9a66-e063-6394a90a5d17	2026-01-13	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Xpect Ibuprofen	IBUPROFEN	Cintas Corporation	976ba88a-6428-40d1-a2fd-eac64963ba1d	2026-01-08	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Lil Drug Store Ibuprofen	IBUPROFEN	Lil Drug Store Products, Inc	29190ebf-bb9c-4406-be7b-4427741aeb74	2025-12-23	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	CVS	10424ad8-74fc-4f5f-e063-6394a90a13bd	2025-12-23	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Granules USA, Inc.	8cb595d2-b7c2-687d-e053-2a95a90a5720	2025-12-22	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Retail Business Services, LLC	04115ec1-ef31-1746-e063-6394a90a0a52	2025-12-19	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES,LLC.	a567dc6f-bd83-b9f5-e053-2995a90a05ee	2025-12-19	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	TOPCO ASSOCIATES LLC	1a00c17f-9766-deaa-e063-6394a90a8d60	2025-12-19	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
IBUPROFEN	IBUPROFEN	WALGREENS CO.	b8a77b7e-e161-b3ac-e053-2995a90af3e8	2025-12-19	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Family Dollar	fe17f5a6-fd6d-d839-e053-6394a90a59a4	2025-12-19	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS LLC.	8c3ca03e-0ec2-c15c-e053-2995a90ad8bd	2025-12-18	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174

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	7ceacd63-d5fa-4cab-b8f3-a5131c97bb90	1
310965	ibuprofen 200 MG Oral Tablet	SCD	7ceacd63-d5fa-4cab-b8f3-a5131c97bb90	1
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	7ceacd63-d5fa-4cab-b8f3-a5131c97bb90	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
37835-581-25	37835058125	250 TABLET in 1 BOTTLE (37835-581-25)	250 tablet	2025-02-01	No	No	Current