Ibuprofen

Product NDC: 21130-392
11-digit product format: 211300392
Labeler code: 21130
Product ID: 21130-392_ee945b69-bdc8-413c-983c-396b5bab763f
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Better Living Brands, LLC
Application: ANDA075139
Marketing category: ANDA
Marketing start: 2002-03-30
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21130-392		D	Discontinued by firm	2026-08-03
excluded package	package	21130-392	21130-392-12	D	Discontinued by firm	2026-08-03
excluded package	package	21130-392	21130-392-15	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 · 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	21130-392-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21130-392-12	`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	21130-392-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21130-392-12	`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	21130-392-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21130-392-12	`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	21130-392-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21130-392-12	`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	21130-392-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21130-392-12	`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	21130-392-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21130-392-12	`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	21130-392-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21130-392-12	`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	21130-392-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21130-392-12	`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	21130-392-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21130-392-12	`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	21130-392-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21130-392-12	`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	21130-392-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21130-392-12	`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	21130-392-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21130-392-12	`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…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	IBUPROFEN TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	IBUPROFEN TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	1

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-392-12	21130039212	1 BOTTLE in 1 CARTON (21130-392-12) > 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2002-03-30	0000-00-00	No	No	Current
21130-392-15	21130039215	1 BOTTLE in 1 CARTON (21130-392-15) > 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2002-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Signature Care 44-392	Better Living Brands, LLC \| LNK International, Inc.	2022-04-08	HUMAN OTC DRUG LABEL	9