Application 071002

Type: ANDA
Sponsor: BAYER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIDOL	IBUPROFEN	CAPSULE;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A071002-001	MIDOL	IBUPROFEN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1987-09-02

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1987-09-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1987-09-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1987-09-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1987-09-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1987-09-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1987-09-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1987-09-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1987-09-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1987-09-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`f41ea6bd6efb…`

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 19 of 47 · 940 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KOSHER MEDS	IBUPROFEN	Mollec Inc	c9c31326-6a19-9a9c-e053-2a95a90aed06	2025-10-29	Warnings	Name fallback generic name: IBUPROFEN
Kosher Meds Dye-Free Ibuprofen	IBUPROFEN	Mollec Inc	ba1a0bc2-0a28-4d73-9667-5a220b806e87	2025-10-29	Warnings	Name fallback generic name: IBUPROFEN
Up and Up Childrens Ibuprofen	IBUPROFEN	Target Corporation	17b3ca97-1bd6-4e76-a47f-2e35ef36b707	2025-10-28	Warnings	Name fallback generic name: IBUPROFEN
childrens ibuprofen 100	IBUPROFEN	Walgreen Company	7b798146-393f-422c-87f0-0bf800df0c71	2025-10-28	Warnings	Name fallback generic name: IBUPROFEN
careone childrens ibuprofen	IBUPROFEN	American Sales Company	bca90b40-7973-4f22-8647-44cce5a6036e	2025-10-28	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	8d5f7d2a-af48-4d47-8bf5-48f01c092d24	2025-10-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	4b75bd6f-5455-4237-991c-eacc0fdcf709	2025-10-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
childrens ibuprofen 100	IBUPROFEN	Walgreen Company	9b748f51-1d09-46ca-9dba-fec226c027e0	2025-10-26	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CVS Pharmacy	93f8101c-1cf7-4cb0-9c00-c57c9f9023c8	2025-10-26	Warnings	Name fallback generic name: IBUPROFEN
Up and Up Childrens Ibuprofen	IBUPROFEN	Target Corporation	eead7d57-dfd3-4007-a620-74afebc3d365	2025-10-26	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Family Dollar (FAMILY WELLNESS)	3a02af7e-7e69-45a6-97d7-ddc7d92b28b3	2025-10-22	Warnings	Name fallback generic name: IBUPROFEN
Foster and Thrive Ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	bcfa45ac-63d6-49a7-aa1c-b9f1d6c571f3	2025-10-22	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen Minis	IBUPROFEN	Family Dollar (FAMILY WELLNESS)	72f933d8-cf01-4bb6-a552-e3cdb297038b	2025-10-21	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	41351cc0-5ec6-2f4d-e063-6294a90a733a	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	Safeway	6dbf5acc-46a1-4d5b-a9a6-9b77f106d711	2025-10-14	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Direct_rx	1be33b4f-4987-580f-e063-6294a90a3103	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Coupler LLC	410f7320-4caa-8f88-e063-6394a90acf93	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	a85080d7-50b4-461b-9d77-d6fbab971c03	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Rite Aid Corporation	1dba3cb7-2e3d-4378-93cf-92db8f24f41f	2025-10-09	Warnings	Name fallback generic name: IBUPROFEN
RIGHT REMEDIES Ibuprofen 200 MG	IBUPROFEN	Strive Pharmaceuticals Inc.	5c155210-d16f-487e-983d-c7b0f97365c6	2025-10-08	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.