Home NDC 57483-530 Regoxidine
Product NDC 57483-530
11-digit product format 574830530
Labeler code 57483
Product ID 57483-530_36bf641f-2d8d-44ee-a5db-36d1135eebeb
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Innovus Pharmaceuticals, Inc.
Application ANDA209074
Marketing category ANDA
Marketing start 2019-01-02
Substance MINOXIDIL
Active strength 50 mg/g
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 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 A209074-001 MINOXIDIL (FOR MEN) MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2018-12-31 A209074-002 MINOXIDIL (FOR WOMEN) MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2019-04-22
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.
Product history page 1 of 3 · 84 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 2026-08-18 06:07:40 2026-07 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209074-001 MINOXIDIL (FOR MEN) 5% AEROSOL, FOAM / TOPICAL 2018-12-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209074-002 MINOXIDIL (FOR WOMEN) 5% AEROSOL, FOAM / TOPICAL 2019-04-22 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base Regoxidine
Brand name suffix (For Men)
Listing expiration 2026-12-31 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57483-530-31 Regoxidine (For Men) 60 g in 1 CAN AEROSOL, FOAM 60 3 57483-530-31 Regoxidine (For Men) 3 in 1 PACKAGE AEROSOL, FOAM 3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57483-530 REGOXIDINE (FOR MEN) (MINOXIDIL) AEROSOL, FOAM [INNOVUS PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20230107_43b58fd3-81a7-4e64-81f3-9d9acfbf6819.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 2 · 22 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Minoxidil MINOXIDIL FOAM 5% (WOMENS) Clarity Cosmetics Inc. 1b54eca8-4a96-1b5e-e063-6394a90a7b94 2026-05-08 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (For Women) MINOXIDIL CVS Pharmacy b10eb8fd-8301-4c38-af4c-220fe5c3b592 2026-04-06 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (For Men) MINOXIDIL CVS Pharmacy f6d90382-dc51-480c-a46c-bad041915d07 2026-04-06 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil 5% (For Men) MINOXIDIL Sun Pharmaceutical Industries, Inc. 52210e2d-d87c-4b53-9b58-95c65c9d11fa 2026-03-10 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil For Women MINOXIDIL Sun Pharmaceutical Industries, Inc. 82d7a480-46b2-423b-8da0-a4fc252f7747 2026-03-10 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Gemachlich ZuHause Hair Growth Foam (Men) HAIR GROWTH FOAM (MEN) Guangdong Quadrant Ecological Technology Co., Ltd. 3abe6f17-17ed-e25c-e063-6294a90a4d4d 2025-07-25 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (for Women) MINOXIDIL Virtue Labs, LLC 85a9d343-1135-4296-96b5-fabab6b834f9 2025-07-17 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (for Men) MINOXIDIL RESTORATION HOLDINGS, LLC e18223ad-642e-81a5-e053-2a95a90a0752 2024-12-11 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (for Women) MINOXIDIL SCIENTIFIC HAIR RESEARCH, LLC 19603dd4-2099-479d-9e6e-14c5d1c49928 2024-07-03 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (for Men) MINOXIDIL SCIENTIFIC HAIR RESEARCH, LLC 5b8fe2d9-c7c5-4563-82f2-3d6bff08b830 2024-07-03 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (For Men) MINOXIDIL TARGET Corporation 5505e1b2-8c9b-457c-8291-cb8a9c1f6b10 2024-05-17 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (For Women) MINOXIDIL TARGET Corporation 3a6bef39-1d8e-4ce3-9484-becd294566da 2024-04-16 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (For Men) MINOXIDIL SPAZI INC. 2b6abc4d-3596-4411-a9f8-77c338c99a5d 2024-01-23 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (For Women) MINOXIDIL SPAZI INC. facdb1c2-c36e-4bcc-a821-f8bad8bb17aa 2024-01-23 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Regoxidine (For Men) MINOXIDIL Innovus Pharmaceuticals, Inc. 43b58fd3-81a7-4e64-81f3-9d9acfbf6819 2022-12-16 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 57483-530 Regoxidine (For Women) MINOXIDIL Innovus Pharmaceuticals, Inc. b60cc177-700c-4007-be1a-2cb74824e657 2022-12-16 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (For Women) MINOXIDIL Kroger Company c443fadd-669e-4d29-8b11-ef3c022ca6f4 2022-10-25 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil 5% (For Men) MINOXIDIL Kroger Company 8346788b-88b3-45c6-8c27-b34a810154fb 2022-10-24 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (For Men) MINOXIDIL Walgreen Company 39526f7d-5e39-4e2e-8689-94b76ddbc462 2022-10-10 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074 Minoxidil (For Women) MINOXIDIL Walgreen Company 8a32828d-1591-478d-aed3-5159232675b4 2022-10-10 Warnings Exact identifier application applno (ANDA): 209074 application number: ANDA209074
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 57483-530-31 57483053031 3 CAN in 1 PACKAGE (57483-530-31) / 60 g in 1 CAN 3 can 2019-11-12 0000-00-00 No No Current