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001	MIDOL	IBUPROFEN	CAPSULE;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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A071002-001	MIDOL	IBUPROFEN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1987-09-02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A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`caaa826d4ba7…`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UTC	2026-02	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`011fe1cb6892…`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of this ZIP	2025-12	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`31067a03dcf5…`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UTC	2025-08	A071002-001	MIDOL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1987-09-02	`6a471c1ec25d…`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 22 of 47 · 940 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHILDRENS IBUPROFEN	IBUPROFEN	7-Eleven	af0ec23c-cefc-40a9-ab9a-03b8528d4e13	2025-09-01	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	Aurohealth LLC	0e1bcb06-be48-4efc-82e2-516582e02348	2025-09-01	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	KROGER COMPANY	15e72384-3a04-242d-e063-6294a90aa0fa	2025-09-01	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	7-Eleven	cf7b38fc-0590-126a-e053-2a95a90a3e78	2025-09-01	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	Chalkboard Health	c63eb5c6-adac-4d23-9661-1081ba4591ba	2025-09-01	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	Randob Labs., Ltd.	50d6bf9d-ae37-4af3-bfeb-cc0abf8cb094	2025-09-01	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	Aurohealth LLC	ad55d9b1-17b3-4a17-a4a3-d95ba2943959	2025-09-01	Warnings	Name fallback generic name: IBUPROFEN
careone childrens ibuprofen	IBUPROFEN	American Sales Company	bf88f91c-70ed-42be-b79c-ec60d4f0acda	2025-08-30	Warnings	Name fallback generic name: IBUPROFEN
Leader Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	5975c324-2906-4e71-9b88-2e772d9fbfde	2025-08-28	Warnings	Name fallback generic name: IBUPROFEN
Good Neighbor Pharmacy Childrens Ibuprofen	IBUPROFEN	Amerisource Bergen	f0a7070b-8acf-49f0-88c8-c841f73242d8	2025-08-28	Warnings	Name fallback generic name: IBUPROFEN
foster and thrive ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	cfa8578c-2bcc-4aa7-bb8c-0d0e193020ed	2025-08-28	Warnings	Name fallback generic name: IBUPROFEN
good neighbor pharmacy childrens ibuprofen	IBUPROFEN	Amerisource Bergen	7a314b7f-91d6-4196-bd96-2470ff7b0b25	2025-08-28	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Rite Aid Corporation	389454b7-c17d-4413-b1ab-dee9a13f81cf	2025-08-25	Warnings	Name fallback generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	Kroger Company	1b78bdeb-efb2-4f5a-af3f-d67d82090847	2025-08-22	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Publix Super Markets Inc	c5cd3843-8d72-4850-bebe-4ac54e4f43fa	2025-08-21	Warnings	Name fallback generic name: IBUPROFEN
equate ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	abef43bc-ee9b-4a9c-9cf9-36c323213909	2025-08-21	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Bryant Ranch Prepack	230fd746-92e0-40b6-9a90-595812bd8a18	2025-08-20	Warnings	Name fallback generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	Meijer Distribution Inc	d42f9f7c-fe4f-45eb-a455-bffb41295fdc	2025-08-20	Warnings	Name fallback generic name: IBUPROFEN
equaline childrens ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	3a166a74-cdc4-4620-b796-750464e15dc0	2025-08-20	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	BJWC (Berkley & Jensen / BJ's)	2f322afb-bfc8-9dab-e063-6394a90a08b5	2025-08-19	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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