Home Applications 021472 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 Product TE source text 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 43 of 46 · 917 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Proficient Rx LP 2dc3108f-d917-40c6-865d-c900cf055d1c 2022-04-01 Boxed warning, Warnings, Adverse reactions Name fallback generic name: IBUPROFEN ibuprofen IBUPROFEN Proficient Rx LP 798d33b0-5d7a-4445-8a51-2a3d336f744a 2022-04-01 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Proficient Rx LP 444b2ea0-ec42-4bcf-b8d2-38b4b297ada0 2022-04-01 Boxed warning, Warnings, Adverse reactions Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Aurohealth LLC 1100648c-6b9f-49c9-94d0-c40f24fe5c27 2022-03-23 Warnings Name fallback generic name: IBUPROFEN basic care ibuprofen IBUPROFEN Amazon.com Services LLC 9bbbedb3-e0b2-4645-8105-98800096cfed 2022-03-09 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Aurohealth LLC 3b0e77a1-b49d-4c67-81dd-66450dabcf3b 2022-03-04 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Aurohealth LLC 0ade8ee2-7c74-4b05-925e-d92742fc2b90 2022-03-03 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Aurohealth LLC cf6fbf3b-a0f3-4e08-a981-d183fa285758 2022-03-03 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC 91723661-d0bb-4498-ac59-59bbdc334230 2022-01-27 Boxed warning, Warnings, Adverse reactions Name fallback generic name: IBUPROFEN Pain Relief - Ibuprofen 200 mg IBUPROFEN Health Pharma USA LLC d60a6a11-8c06-cede-e053-2a95a90af7f9 2022-01-20 Warnings Name fallback generic name: IBUPROFEN Concentrated ibuprofen infants IBUPROFEN Wal-Mart Stores, Inc. 00b7fc71-8cf0-4c12-a479-146408f7f91b 2022-01-11 Warnings Name fallback generic name: IBUPROFEN IBUPROFEN IBUPROFEN RITE AID CORPORATION a7aa790a-6d6c-7929-e053-2995a90a1cf8 2022-01-04 Warnings Name fallback generic name: IBUPROFEN IBUPROFEN IBUPROFEN RITE AID a7abf95e-d444-42da-e053-2995a90a88d3 2022-01-03 Warnings Name fallback generic name: IBUPROFEN IBUPROFEN IBUPROFEN RITE AID a7ac8b55-2758-400e-e053-2995a90a0eed 2022-01-03 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN MARKSANS PHARMA LIMITED 3c8df1e5-61bc-4e70-b6b9-8973986ad589 2021-12-21 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN MARKSANS PHARMA LIMITED 859d7190-586f-4766-a7e7-9e800a72d58b 2021-12-21 Warnings Name fallback generic name: IBUPROFEN basic care childrens ibuprofen IBUPROFEN Amazon.com Services LLC 0dec2df9-ba8b-4bc7-b617-773aa08f9273 2021-12-20 Warnings Name fallback generic name: IBUPROFEN Ibuprofen 200 mg IBUPROFEN Allegiant Health 8ba06ba0-bfe9-4626-af65-dae4d6a3a2ad 2021-12-06 Warnings Name fallback generic name: IBUPROFEN basic care childrens ibuprofen IBUPROFEN Amazon.com Services LLC b2a14686-6083-46a1-885c-9f7c30e9c647 2021-11-30 Warnings Name fallback generic name: IBUPROFEN Ibuprofen 200mg IBUPROFEN Allegiant Health f3f12b86-89dc-427e-a26f-728be6f73e7b 2021-11-16 Warnings Name fallback generic name: IBUPROFEN
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.