Home NDC 57483-175 REGOXIDINE (FOR WOMEN)
Product NDC 57483-175
11-digit product format 574830175
Labeler code 57483
Product ID 57483-175_40d86d45-ccc6-4b7e-a152-453469b21379
Type HUMAN OTC DRUG
Nonproprietary name MINOXIDIL
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler INNOVUS PHARMACEUTICALS, INC.
Application ANDA218616
Marketing category ANDA
Marketing start 2025-05-03
Substance MINOXIDIL
Active strength 50 mg/g
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218616-001 MINOXIDIL (FOR MEN) MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2024-04-22 A218616-002 MINOXIDIL (FOR WOMEN) MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2024-04-22
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.
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 2026-08-18 06:07:40 2026-07 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base REGOXIDINE (FOR WOMEN)
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOXIDIL 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5965120SH1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 645146 Internal RxNorm lookup 2264763 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57483-175-01 REGOXIDINE (FOR WOMEN) 60 g in 1 CAN AEROSOL, FOAM 60 4 57483-175-11 REGOXIDINE (FOR WOMEN) 1 in 1 CARTON AEROSOL, FOAM 1 4 57483-175-12 REGOXIDINE (FOR WOMEN) 2 in 1 CARTON AEROSOL, FOAM 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57483-175 REGOXIDINE (FOR WOMEN) (MINOXIDIL) AEROSOL, FOAM [INNOVUS PHARMACEUTICALS, INC.] 1 Current NDC, 3 package rows 20250507_9c06c34d-5a09-47ed-b969-cc81f4ed61ab.zip
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 1 of 1 · 9 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 57483-175-01 57483017501 60 g in 1 CAN 60 g Historical 57483-175-11 57483017511 1 CAN in 1 CARTON (57483-175-11) / 60 g in 1 CAN (57483-175-01) 1 can 2025-11-14 No No Current 57483-175-12 57483017512 2 CAN in 1 CARTON (57483-175-12) / 60 g in 1 CAN (57483-175-01) 2 can 2025-05-03 No No Current