Home NDC 83091-002 MEN S EXTRA STRENGTH Minoxidil Hair Regrowth Treatment
Product NDC 83091-002
11-digit product format 830910002
Labeler code 83091
Product ID 83091-002_5af6906c-9ca4-c2e8-e063-6294a90a5e85
Type HUMAN OTC DRUG
Nonproprietary name MEN S EXTRA STRENGTH Minoxidil Hair Regrowth Treatment
Dosage form SOLUTION
Route TOPICAL
Labeler Anhui Cao coral biology science and technology co., ltd
Application ANDA076239
Marketing category ANDA
Marketing start 2026-09-08
Substance MINOXIDIL
Active strength 5 g/100mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076239-001 THEROXIDIL MINOXIDIL 5% SOLUTION / TOPICAL 2004-08-24
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 2 · 43 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 2026-09-14 22:38:34 2026-08 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076239-001 THEROXIDIL 5% SOLUTION / TOPICAL 2004-08-24 f41ea6bd6efb…
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 MEN S EXTRA STRENGTH Minoxidil Hair Regrowth Treatment
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOXIDIL 5 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 311724 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 2 of 2 · 31 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Minoxidil Extra Strength for Men MINOXIDIL Roman Health Ventures Inc. a568aba1-1016-4380-e053-2a95a90a396d 2025-01-08 Warnings Exact identifier application applno (ANDA): 076239 application number: ANDA076239 Tomum Hair Growth Treatment For Men Minoxidil Unscented MINOXIDIL BELLEKA INC 4c0582a3-f2be-4e53-a174-12269f7ddad0 2024-12-04 Warnings Exact identifier application applno (ANDA): 076239 application number: ANDA076239 Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength MINOXIDIL ESALON.COM, LLC 69b01eab-df9f-4ae8-87e4-add18883874b 2024-11-05 Warnings Exact identifier application applno (ANDA): 076239 application number: ANDA076239 Elevate Hair Regrowth Treatment 5 MINOXIDIL VAPOR PRO SHOPPE, LLC 0d5e4258-a58d-4378-9be8-631114588cdb 2024-10-31 Warnings Exact identifier application applno (ANDA): 076239 application number: ANDA076239 DAVV Minoxidil Topical Solution Mens Hair Regrowth Treatment MINOXIDIL Good Manager Holdings Inc 16b36a38-72c3-4a19-a28c-757ae02e097a 2024-10-28 Warnings Exact identifier application applno (ANDA): 076239 application number: ANDA076239 Elevate Hair Regrowth Treatment 5 Minoxidil Solution MINOXIDIL VAPOR PRO SHOPPE, LLC 12737299-1052-4c93-afab-20016b9d9001 2024-07-22 Warnings Exact identifier application applno (ANDA): 076239 application number: ANDA076239 GROWELL Mens Hair Regrowth Treatment 5 Minoxidil MINOXIDIL APIRA SCIENCE, INC. 8cd4a3a9-94ba-48c7-8516-b50504c2c440 2024-05-16 Warnings Exact identifier application applno (ANDA): 076239 application number: ANDA076239 BOSLEY Minoxidil Topical Solution 5 (for men) MINOXIDIL Scientific Hair Research, LLC 90d96eb1-a478-42ce-9389-642c57bbf280 2024-05-01 Warnings Exact identifier application applno (ANDA): 076239 application number: ANDA076239 BOSLEY Man 5 Minoxidil Topical Solution MINOXIDIL Scientific Hair Research, LLC c692b47d-12c3-4225-9eee-b08ca76e4daa 2023-10-26 Warnings Exact identifier application applno (ANDA): 076239 application number: ANDA076239 SUAVECITO 5% Minoxidil Solution MINOXIDIL SUAVECITO, INC. a6d3c488-f943-4edf-9d6b-21a3dee92d78 2023-07-18 Warnings Exact identifier application applno (ANDA): 076239 application number: ANDA076239 Regenpure Precision MINOXIDIL Salonceuticals, Inc. 4a113921-b2a9-42cc-e054-00144ff8d46c 2017-03-06 Warnings Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83091-002-01 83091000201 2 BOTTLE in 1 BOX (83091-002-01) / 60 mL in 1 BOTTLE 2 bottle 2026-09-08 No No Current