Ibuprofen

Product NDC: 41250-048
11-digit product format: 412500048
Labeler code: 41250
Product ID: 41250-048_1da26c05-41be-4502-b0bd-9871b09ed10d
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: MEIJER, INC.
Application: ANDA078682
Marketing category: ANDA
Marketing start: 2015-02-28
Marketing end: 2021-12-30
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	41250-048		D	Discontinued by firm		2026-08-07
excluded package	package	41250-048	41250-048-80	D	Discontinued by firm		2026-08-07

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 · 24 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	41250-048-80	`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	41250-048-80	`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	41250-048-80	`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	41250-048-80	`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	41250-048-80	`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	41250-048-80	`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	41250-048-80	`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	41250-048-80	`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	41250-048-80	`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	41250-048-80	`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	41250-048-80	`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	41250-048-80	`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
A078682-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2009-03-24

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	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN CAPSULE, LIQUID FILLED [MEIJER, INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN CAPSULE, LIQUID FILLED [MEIJER, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	IBUPROFEN CAPSULE, LIQUID FILLED [MEIJER, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	IBUPROFEN CAPSULE, LIQUID FILLED [MEIJER, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	IBUPROFEN CAPSULE, LIQUID FILLED [MEIJER, INC.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	IBUPROFEN CAPSULE, LIQUID FILLED [MEIJER, INC.]	1
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	IBUPROFEN CAPSULE, LIQUID FILLED [MEIJER, INC.]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	IBUPROFEN CAPSULE, LIQUID FILLED [MEIJER, INC.]	1
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	IBUPROFEN CAPSULE, LIQUID FILLED [MEIJER, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	IBUPROFEN CAPSULE, LIQUID FILLED [MEIJER, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN CAPSULE, LIQUID FILLED [MEIJER, INC.]	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 3 · 60 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen mini dye free	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC.	552d9018-cc7e-7e1a-e063-6294a90a3322	2026-06-26	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	TOP CARE (Topco Associates LLC)	fb842f4d-1228-9a52-e053-6294a90adb41	2026-06-26	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen Mini Dye Free	IBUPROFEN	CVS Pharmacy	42c7dbec-2e53-70ae-e063-6294a90a16e6	2026-06-25	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	TOP CARE (Topco Associates LLC)	c62cc12f-5a0e-389a-e053-2995a90a208c	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	TOP CARE (Topco Associates LLC)	c6297c23-3b27-c0c6-e053-2995a90a3e76	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	MEIJER DISTRIBUTION INC.	a139e495-3dbf-4998-e053-2a95a90ac136	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
pain relief	IBUPROFEN	Bionpharma Inc.	a14ca126-fada-c903-e053-2995a90ae72d	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	HEB	ca4be24c-5d92-ddc9-e053-2a95a90aa5a7	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	DOLGENCORP INC	03138a6f-653a-f359-e063-6394a90ac5d6	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN CAPSULE	PUBLIX SUPER MARKETS INC	10a6eba7-e400-ce97-e063-6294a90af3bd	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
IBUPROFEN	IBUPROFEN	DISCOUNT DRUG MART, INC.	d07ea9e3-88b0-4aa0-903a-10555dcca37d	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	DISCOUNT DRUG MART, INC.	aae40114-343e-12da-e053-2a95a90a9213	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	BJWC	0ca0b6cf-7d1f-4673-b9b9-48f78d80c00a	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
pain relief	IBUPROFEN	Bionpharma Inc.	2b4ecdd8-627a-445f-8ddc-f2b6c832c1e8	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
dye-free pain relief	IBUPROFEN	Bionpharma Inc.	c46c9c36-8844-7b50-e053-2a95a90aa0e9	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
dye-free pain relief	IBUPROFEN	Bionpharma Inc.	4227d0b7-846a-dcb0-e063-6294a90af7d7	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC.	3c1c1b65-f57f-62b0-e063-6294a90a1021	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	Chain Drug Marketing Association, Inc.	3802982a-2373-9ca3-e063-6394a90a0ab7	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC.	4573753d-117b-a6f2-e063-6394a90ae2f9	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	Chain Drug Marketing Association, Inc.	3ed7faff-fd48-0a83-e063-6394a90aab14	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682

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	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-048-80	41250004880	80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (41250-048-80)	2015-02-28	2021-12-30	No	No	Current