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 4 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	b81c6495-8b30-41ef-8a0f-4cbfd87f1eb4	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d8	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	57a1bf99-5aaf-432d-86ba-5f0e7cfab1a0	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	HyVee Inc	e7175dc9-db39-4452-a419-85af179de422	2026-07-16	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	9de61620-6750-4fb6-89a4-fe451ab8d99f	2026-07-15	Warnings	Name fallback generic name: IBUPROFEN
Ibuwin Forte	IBUPROFEN	OPMX LLC	0daf1be9-ea38-461e-e063-6394a90a7954	2026-07-15	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Strides Pharma Science Limited	38ebacc3-378f-483e-babc-76119677e7df	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	f1c88d74-09b0-4b14-baea-106fbbbc54bf	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	0387bfaa-daca-48ec-b718-0216a848c16a	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	ATLANTIC BIOLOGICALS CORP.	3ce7549f-e4db-9f89-e063-6294a90a126d	2026-07-10	Warnings	Name fallback generic name: IBUPROFEN
good sense ibuprofen	IBUPROFEN	Bryant Ranch Prepack	d6460cc3-c207-44e0-bf78-ad6fef055ed5	2026-07-09	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	St. Mary's Medical Park Pharmacy	0a98cce4-f5c0-12a8-e063-6294a90a4e7e	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	b6a6c940-daf6-4e0e-aefb-35cce87a9a55	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	421156d2-85dc-4680-b2b4-d15b67539e87	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Better Living Brands, LLC	45520969-7a2d-4469-ba25-7db160d50ccf	2026-07-06	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	c0156053-add5-4bd5-b89f-f90df2e73be4	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	20078671-536f-4b0b-a079-f90ac186a670	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
ADVIL	IBUPROFEN	Select Consumer Group	3ca752d8-957c-21b4-e063-6294a90a5285	2026-07-03	Warnings	Name fallback generic name: IBUPROFEN
Advil Liquigel	IBUPROFEN	Select Consumer Group	3ca6bc9d-090f-e412-e063-6394a90a6876	2026-07-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	34a9b94f-93ba-4a7c-92eb-d0b4b530d887	2026-07-02	Boxed warning, Warnings, Adverse reactions	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