ibuprofen

Product NDC: 41250-057
11-digit product format: 412500057
Labeler code: 41250
Product ID: 41250-057_a0d52a96-9254-447f-b46b-c1534ccfe359
Type: HUMAN OTC DRUG
Nonproprietary name: ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Meijer Distribution Inc
Application: ANDA075217
Marketing category: ANDA
Marketing start: 2000-03-17
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 50 mg/1.25mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	41250-057		D	Discontinued by firm		2026-08-03
excluded package	package	41250-057	41250-057-10	D	Discontinued by firm		2026-08-03

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
A075217-001	IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL			1998-12-16

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	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-057	IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]	6	Legacy NDC	20210925_cf24da4b-69de-43b6-9a84-b474c912ae3f.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 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ibuprofen	IBUPROFEN	Rite Aid Corporation	99a76de3-166a-4902-b400-b262a4fa0ae8	2026-05-27	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Good Sense Infants Ibuprofen	IBUPROFEN	L. Perrigo Company	3d2fa7ad-1574-4c79-959d-3ee284468a99	2026-05-11	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
ibuprofen infants	IBUPROFEN	H E B	e353bc69-c03e-4bae-a357-f7f3fab91695	2026-05-07	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
infants dye free ibuprofen	IBUPROFEN	Kroger Company	6dc009c8-5b44-4d53-b053-eaed2223d975	2026-05-05	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Good Sense ibuprofen infants	IBUPROFEN	L. Perrigo Company	c79e65e7-149b-450f-b083-99e16ff71729	2026-04-14	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
care one ibuprofen	IBUPROFEN	American Sales Company	15f63d40-276c-4c02-9f8c-0354e4779916	2026-04-09	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
ibuprofen	IBUPROFEN	CVS Pharmacy	e28d0916-8165-431c-a19c-ef7d4bb6b8e6	2026-02-26	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
ibuprofen infants	IBUPROFEN	HyVee Inc	e8fcaf17-234a-4d64-b621-9ca505884b0a	2026-01-12	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Foster and Thrive Ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	bcfa45ac-63d6-49a7-aa1c-b9f1d6c571f3	2025-10-22	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
ibuprofen	IBUPROFEN	Meijer Distribution Inc	e28e64dc-5f4e-4260-953a-3de38a5eaa76	2025-09-15	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
INFANTS IBUPROFEN	IBUPROFEN	Safeway	6fed7c65-69a3-4899-a85d-23ea95f571a4	2025-07-21	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
profen ib infants	IBUPROFEN	Publix Super Markets Inc	84aea3fc-4f3b-4a76-a3a6-94ed6549dbea	2025-07-17	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Dg Health Ibuprofen	IBUPROFEN	Dolgencorp, LLC	9022e393-084e-499b-ac84-f35360d79592	2025-07-17	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
dg health ibuprofen	IBUPROFEN	Dolgencorp, LLC	d6dcbdee-7c0d-4b5c-b0c1-1e8f357f7f59	2025-05-15	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Equaline Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	c611afc0-5cde-4f01-908a-de52cb61ab02	2025-05-08	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
ibuprofen	IBUPROFEN	Major Pharmaceuticals	b4962985-47e6-4389-874f-76742b086e2f	2025-05-03	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
Topcare Infants Ibuprofen	IBUPROFEN	Topco Associates LLC	00d33273-e8c7-4d40-8e6f-a980f746fff2	2025-05-03	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
profen ib	IBUPROFEN	Publix Super Markets Inc	bee4b754-c476-4d0e-a1b4-4db8861af84a	2025-05-01	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
parents choice infants ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	a826d6cc-f582-4508-897d-0d637de0666c	2025-04-07	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217
up and up dye free infants concentrated ibuprofen	IBUPROFEN	Target Corporation	6cfdcd94-95cb-4447-a14b-cdb49a1e3114	2025-04-07	Warnings	Exact identifier application applno (ANDA): 075217 application number: ANDA075217

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
41250-057-10	41250005710	1 BOTTLE in 1 CARTON (41250-057-10) > 30 mL in 1 BOTTLE	1 bottle	2003-11-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Infants' Ibuprofen Drug Facts	Meijer Distribution Inc	2021-09-17	HUMAN OTC DRUG LABEL	6