Ibuprofen

Product NDC: 37808-393
11-digit product format: 378080393
Labeler code: 37808
Product ID: 37808-393_fb73f7f9-e6bc-4205-ba85-032ce0d551fc
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H E B
Application: ANDA075139
Marketing category: ANDA
Marketing start: 1999-03-01
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: 2027-12-31
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	37808-393	37808-393-20	D	Discontinued by firm		2026-08-03

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 · 12 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A075139-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1999-03-01

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	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075139-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Listing expiration: 2027-12-31

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
88c7486b-f9a7-4856-a25a-7c06e1382f1a	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
37808-393-12	Ibuprofen	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	14
37808-393-12	Ibuprofen	1 in 1 CARTON	TABLET, FILM COATED	1	14
37808-393-13	Ibuprofen	250 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	250	14
37808-393-20	Ibuprofen	225 in 1 BOTTLE	TABLET, FILM COATED	225	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN CAPSULE, COATED [H E B]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN CAPSULE, COATED [H E B]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN CAPSULE, COATED [H E B]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	IBUPROFEN CAPSULE, COATED [H E B]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN CAPSULE, COATED [H E B]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	IBUPROFEN CAPSULE, COATED [H E B]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN CAPSULE, COATED [H E B]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	IBUPROFEN CAPSULE, COATED [H E B]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN CAPSULE, COATED [H E B]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IBUPROFEN CAPSULE, COATED [H E B]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN CAPSULE, COATED [H E B]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN CAPSULE, COATED [H E B]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-393	IBUPROFEN TABLET, FILM COATED [H E B]	13	Current NDC, Legacy NDC, 4 package rows	20250217_88c7486b-f9a7-4856-a25a-7c06e1382f1a.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 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Better Living Brands, LLC	45520969-7a2d-4469-ba25-7db160d50ccf	2026-07-06	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	027ded51-aa01-6619-3938-c8162a421cf3	2026-06-18	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. DBA Leader	a41a0bc2-ef7a-44cd-a42e-aefab41323cc	2026-06-15	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	ARMY AND AIR FORCE EXCHANGE SERVICE	01f8fe3a-8810-4b38-8860-d95e05d37709	2026-06-15	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	260f5862-d65d-4c34-bf53-26ca30806a67	2026-05-19	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	Meijer Distribution, Inc.	3e3a5366-535d-45fb-81af-c7d98ac20b11	2026-05-15	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen Dye Free	IBUPROFEN	CVS Pharmacy	00653b7c-7099-487e-9a01-e89781c21323	2026-04-29	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	Meijer Distribution Inc	36f7227d-f3cb-44b7-a4c1-27611cd15052	2026-04-24	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	Rite Aid Corporation	72e11f2d-a348-4c12-9cd8-1e6f0f6f7399	2026-04-09	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen Dye-Free	IBUPROFEN	Wal-Mart Stores Inc	23cb5001-6aeb-434a-b2e8-aaf8bbab9dc6	2026-04-01	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen Dye Free	IBUPROFEN	WALMART INC.	2b04d255-a1df-4698-9b5a-ad7a12205e1b	2026-03-25	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
pain relief ibuprofen	IBUPROFEN	Rite Aid Corporation	2bd1438e-27b1-81ff-f8e1-0f5b50b04581	2026-02-02	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	H E B	88c7486b-f9a7-4856-a25a-7c06e1382f1a	2026-02-02	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 37808-393
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	82e907e6-86a9-5c7f-93bd-a6319d74100f	2026-01-13	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	8ebe3e16-b7ae-d333-6671-5bc935e25900	2026-01-13	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	c93da67f-f42e-4baa-976b-73c71ba6dd71	2026-01-12	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f6	2025-12-17	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Dye Free Ibuprofen	IBUPROFEN	Walgreen Company	d3d093f9-207a-40d4-a7be-c6b5a544a0a7	2025-12-12	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	Family Dollar Services Inc	89ed9311-2185-4660-b219-9ea67b1a71ec	2025-11-15	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Ibuprofen	IBUPROFEN	Topco Associates, LLC	bcf7d4c1-1f99-48df-8f74-9abeefa8d41d	2025-11-15	Warnings	Exact identifier application applno (ANDA): 075139 application number: ANDA075139

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	88c7486b-f9a7-4856-a25a-7c06e1382f1a	14
310965	ibuprofen 200 MG Oral Tablet	SCD	88c7486b-f9a7-4856-a25a-7c06e1382f1a	14
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	88c7486b-f9a7-4856-a25a-7c06e1382f1a	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-393-12	37808039312	1 BOTTLE, PLASTIC in 1 CARTON (37808-393-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1999-03-01	0000-00-00	No	No	Current
37808-393-13	37808039313	250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (37808-393-13)	1999-03-01	0000-00-00	No	No	Current
37808-393-20	37808039320	225 in 1 BOTTLE					Historical