Home NDC 59640-000 minoxidil topical
Product NDC 59640-000
11-digit product format 596400000
Labeler code 59640
Product ID 59640-000_849cfecb-caff-4634-ab5d-9e944649ffb4
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form SOLUTION
Route TOPICAL
Labeler H E B
Application ANDA075357
Marketing category ANDA
Marketing start 2021-12-31
Substance MINOXIDIL
Active strength 2 g/100mL
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A075357-001 MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION / TOPICAL 1999-07-30 A075357-002 MINOXIDIL (FOR WOMEN) MINOXIDIL 2% SOLUTION / TOPICAL 1999-07-30
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base minoxidil topical
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOXIDIL 2 g/100mL
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 311723 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 59640-000-16 minoxidil topical 60 mL in 1 BOTTLE SOLUTION 60 3 59640-000-16 minoxidil topical 1 in 1 CARTON SOLUTION 1 3 59640-000-30 minoxidil topical 60 mL in 1 BOTTLE SOLUTION 60 3 59640-000-30 minoxidil topical 3 in 1 CARTON SOLUTION 3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59640-000 MINOXIDIL TOPICAL (MINOXIDIL) SOLUTION [H E B] 3 Current NDC, Legacy NDC, 4 package rows 20240718_c9da0a80-2737-4e36-bbef-f7c4ae046ad7.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 · 18 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59640-000-16 59640000016 1 BOTTLE in 1 CARTON (59640-000-16) / 60 mL in 1 BOTTLE 1 bottle 2021-12-31 0000-00-00 No No Current 59640-000-30 59640000030 3 BOTTLE in 1 CARTON (59640-000-30) / 60 mL in 1 BOTTLE 3 bottle 2022-01-06 0000-00-00 No No Current