Application 021472

Type: NDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIDOL LIQUID GELS	IBUPROFEN	CAPSULE;ORAL	200MG	Yes	Yes

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
N021472-001	MIDOL LIQUID GELS	IBUPROFEN	200MG	CAPSULE / ORAL		RLD, RS	2002-10-18

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021472-001	MIDOL LIQUID GELS	200MG	CAPSULE / ORAL	RLD, RS	2002-10-18	`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 46 of 46 · 917 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Bionpharma Inc.	d7d00fe3-c537-486e-8156-9b56b550bff5	2019-09-06	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Wal-Mart Stores, Inc	c100129d-3754-4d0e-b754-76440d55944a	2019-08-23	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen 200	IBUPROFEN	WALGREEN COMPANY	5fe0bdfa-1d5b-4657-a32b-f531b69bac0d	2019-08-13	Warnings	Name fallback generic name: IBUPROFEN
IBU	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	ffec2f44-1144-4729-b43a-1db40ea6a8d3	2019-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	b234d42e-1333-48a1-8565-35d9759e8085	2019-03-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Topco Associates LLC	4aef9935-2e36-4779-a8a8-5288060573af	2019-03-08	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	4a86a190-da5d-4b7a-a05f-e3e7ccbfa603	2019-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Care One ibuprofen childrens	IBUPROFEN	American Sales Company	703869c9-7f12-4556-a2af-8e68942834f2	2018-11-26	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Contract Pharmacal Corp.	237bcb87-64a0-415b-bd53-e9d3b8bf33b6	2018-11-07	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Geritrex LLC	ca9498ec-755d-4a09-9504-210dd48d6fed	2018-10-12	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Guardian Drug Company	694866ce-c419-4b4c-bfb2-4175703d89f1	2018-09-07	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen Childrens	IBUPROFEN	H E B	0a9a54ce-572f-4a96-922f-cc136d2d4aad	2018-06-07	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Breeden Brothers, LLC	e4314153-479d-4c0f-ba49-4d4efded304b	2018-04-06	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	acc4cbc8-085d-42f3-ad93-113e0b55631c	2017-11-09	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CVS PHARMACY, INC.	cdd5a402-df90-4a16-a38c-78eab7189998	2017-11-09	Warnings	Name fallback generic name: IBUPROFEN
Fast Pain Relief	IBUPROFEN	HealthLife of USA LLC	a3fcd34a-6aa9-477c-bbfb-2f6b36e06b65	2017-06-05	Warnings	Name fallback generic name: IBUPROFEN
Dye Free Ibuprofen	IBUPROFEN	Breeden Brothers, LLC	ba106f6f-2c6b-4c98-a10e-d27622b08b25	2017-02-15	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69810	SUPPL	2022-01-05
69074	SUPPL	2021-10-22
47594	SUPPL	2017-03-20
47574	SUPPL	2017-03-17
5469	SUPPL	2010-05-03
27883	SUPPL	2009-04-21
27882	SUPPL	2009-02-23
5468	SUPPL	2006-12-28
27880	SUPPL	2006-03-14
15547	SUPPL	2006-03-14
27881	SUPPL	2006-01-19
42184	ORIG	2004-11-22
15546	SUPPL	2004-02-03
27879	SUPPL	2004-02-02
27878	ORIG	2002-10-18