Home NDC 58602-614-23 MINOXIDIL 5% (FOR MEN)
Product NDC 58602-614
Requested package NDC 58602-614-23
11-digit product format 586020614
Labeler code 58602
Product ID 58602-614_92fa5802-c8f6-4751-bae6-e30d7492e208
Type HUMAN OTC DRUG
Nonproprietary name MINOXIDIL
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Aurohealth LLC
Application ANDA218616
Marketing category ANDA
Marketing start 2026-09-25
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 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 5% (FOR MEN)
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOXIDIL 50 mg/g
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 58602-614-23 58602061423 3 CAN in 1 CARTON (58602-614-23) / 60 g in 1 CAN 3 can 2026-09-25 No No Current