Home NDC 85524-2611 MINOXIDIL (FOR MEN)
Product NDC 85524-2611
11-digit product format 855242611
Labeler code 85524
Product ID 85524-2611_53793182-8a04-1b0f-e063-6294a90acca6
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form LIQUID
Route TOPICAL
Labeler FlexiGo Inc
Application ANDA218616
Marketing category ANDA
Marketing start 2026-06-08
Substance MINOXIDIL
Active strength 5 g/100g
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 43 .
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 2026-09-14 22:38:34 2026-08 A218616-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218616-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2024-04-22 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base MINOXIDIL (FOR MEN)
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOXIDIL 5 g/100g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 645146 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85524-2611-2 85524261102 3 BOTTLE in 1 BAG (85524-2611-2) / 60 g in 1 BOTTLE (85524-2611-1) 3 bottle 2026-06-08 No No Current