FDA.reportPublic FDA data

Minoxidil

Manufacturer
FlexiGo Inc
Effective date
2026-09-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-24 01:01:38

Label at a glance#

ProductMINOXIDIL EXTRA STRENGTH (FOR MEN)
Active ingredientMINOXIDIL
Label structure14 sections

Dosage and administration

DIRECTIONS

Storage and handling

STORAGE AND HANDLING

Label contents#

Full prescribing information#

Minoxidil

OTC - ACTIVE INGREDIENT SECTION

Minoxidil MinoxidilMinoxidil

ask a doctor

OTC - ASK DOCTOR SECTION

ask a doctor ask a doctorask a doctor

Do not use if

OTC - DO NOT USE SECTION

Do not use if Do not use ifDo not use if

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDRENKEEP OUT OF REACH OF CHILDREN

purpose

OTC - PURPOSE SECTION

purpose purposepurpose

questions

OTC - QUESTIONS SECTION

questions questionsquestions

stop use and ask a doctor if

OTC - STOP USE SECTION

stop use and ask a doctor if stop usestop use

when using this product

OTC - WHEN USING SECTION

when using this product when using this productwhen using this product

Warnings

WARNINGS SECTION

Warnings WarningsWarnings

Inactive ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredient Inactive ingredientInactive ingredient

STORAGE AND HANDLING

STORAGE AND HANDLING SECTION

STORAGE AND HANDLING STORAGE AND HANDLINGSTORAGE AND HANDLING

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS DIRECTIONSDIRECTIONS

Drug facts

INDICATIONS & USAGE SECTION

Drug facts UsesUses

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85524-261585524-2615-1, 85524-2615-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINOXIDIL5965120SH1ACTIB
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)MINOXIDIL5%SOLUTION / TOPICAL2001-06-13

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1384e616aacf4f…
2026-08-18 06:07:402026-07A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-133f01610625f2…
2019-09-15 20:21 UTC2019-09A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075598-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2001-06-13f41ea6bd6efb…

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 13 · 253 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MINOXIDIL EXTRA STRENGTH (FOR MEN)MINOXIDILFlexiGo Inc5406743a-b688-346e-e063-6294a90a2caf2026-09-20WarningsName fallback
brand name: MINOXIDIL EXTRA STRENGTH (FOR MEN)
generic name: MINOXIDIL
HAIR REGROWTH TREATMENTMINOXIDILAmazon.com Services LLC0ce77e6b-c4cf-49e2-8fd9-183286c26f8a2026-09-08WarningsName fallback
generic name: MINOXIDIL
EITIKO Minoxidil Hair Regrowth TreatmentMINOXIDILGuangzhou Ariel Medical Technology Co., Ltd.5aa2a552-f8b5-f11a-e063-6394a90abb1a2026-09-04WarningsName fallback
generic name: MINOXIDIL
5% Minoxidil FoamMINOXIDILHONG KONG YUEJIE INTERNATIONAL TRADING LIMITED5a7b2dec-4879-7491-e063-6394a90a874f2026-09-02WarningsName fallback
generic name: MINOXIDIL
HAIR REGROWTH TREATMENTMINOXIDILAmazon.com Services LLC728db7d9-3f38-4006-8024-018f0d9c96da2026-08-31WarningsName fallback
generic name: MINOXIDIL
MINOXIDIL 5% (FOR MEN)MINOXIDILBetter Living Brands, LLC53e33414-2aa4-3dbd-e063-6294a90a06b52026-08-27WarningsName fallback
generic name: MINOXIDIL
MINOXIDIL 5% TOPICAL AEROSOL60gMINOXIDILShenzhen Joyuflsh Technology Co.,Ltd.5a03675b-0bfd-7058-e063-6294a90acf4d2026-08-27WarningsName fallback
generic name: MINOXIDIL
MinoxidilMINOXIDILWalgreens97d4d3ce-316c-4d58-b4dc-28d662b0fb4a2026-08-27WarningsName fallback
generic name: MINOXIDIL
MinoxidilMINOXIDILAmerican Health Packaging0b4fc036-9497-442b-b629-c4b3869327892026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MINOXIDIL
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b4f9e3-c241-6a70-e063-6294a90a364f2026-08-23WarningsName fallback
generic name: MINOXIDIL
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b52a52-dab0-87b5-e063-6294a90a05962026-08-23WarningsName fallback
generic name: MINOXIDIL
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b67ce0-3546-c18a-e063-6394a90ae50a2026-08-23WarningsName fallback
generic name: MINOXIDIL
5% Minoxidil hair growth SerumMINOXIDILGuangzhou Huanmei Cosmetics Co., Ltd.597582b0-cfcc-f7b7-e063-6394a90a0e9a2026-08-20WarningsName fallback
generic name: MINOXIDIL
MinoxidilMINOXIDILBryant Ranch Prepack75b2832c-0a6c-4125-9514-19a6d8dbf6cf2026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MINOXIDIL
MinoxidilMINOXIDILBryant Ranch Prepack8ccd07ab-07ed-4b42-b182-3d22b98abca72026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MINOXIDIL
KIRKLAND SIGNATURE MINOXIDILMINOXIDILCostco Wholesale Company90137bb7-f0e3-4c3c-9cfb-d4d5eed13a9c2026-08-20WarningsName fallback
generic name: MINOXIDIL
apgwgzminoxidil5%MINOXIDILGuangdong Jiaoyu Biotechnology Co., Ltd596d0b43-5cb1-be25-e063-6394a90abbed2026-08-19WarningsName fallback
generic name: MINOXIDIL
apgwgzminoxidil2%MINOXIDILGuangdong Jiaoyu Biotechnology Co., Ltd5957c990-e274-6278-e063-6394a90af2b72026-08-18WarningsName fallback
generic name: MINOXIDIL
MinoxidilMINOXIDILKeranique4af782f4-68d5-4338-a0a6-85d11a23ce982026-08-18WarningsName fallback
generic name: MINOXIDIL
Olivita Extra Strength MinoxidilMINOXIDILOlivita Beauty Incb2da549b-eb79-46ed-aaec-87326c4a1fbe2026-08-17WarningsName fallback
generic name: MINOXIDIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.