FDA.reportPublic FDA data

MINOXIDIL (FOR MEN) - FlexiGo Inc

Manufacturer
FlexiGo Inc
Effective date
2026-11-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-11-05 03:01:35

Label at a glance#

ProductMINOXIDIL (FOR MEN)
Active ingredientMINOXIDIL
Label structure11 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTIONDOSAGE & ADMINISTRATION SECTION

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTIONINACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC-ACTIVE INGREDIENT SECTIONOTC-ACTIVE INGREDIENT SECTION

OTC - DO NOT USE SECTION

OTC-DO NOT USE SECTIONOTC-DO NOT USE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC-KEEP OUT OF REACH OF CHILDRENOTC-KEEP OUT OF REACH OF CHILDREN

OTC - PURPOSE SECTION

OTC-PURPOSE SECTIONOTC-PURPOSE SECTION

OTC - STOP USE SECTION

OTC-STOP USE SECTIONOTC-STOP USE SECTION

OTC - WHEN USING SECTION

OTC-WHEN USINGOTC-WHEN USING

WARNINGS SECTION

WARNINGS SECTIONWARNINGS SECTION

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTIONINDICATIONS & USAGE SECTION

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 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85524-261285524-2612-1, 85524-2612-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINOXIDIL5965120SH1ACTIB
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 60CAL22UVI4MIACT
BUTANE6LV4FOR43RIACT
WATER059QF0KO0RIACT
PROPANET75W9911L6IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETYL ALCOHOL936JST6JCNIACT
ISOBUTANEBXR49TP611IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-09-20daily-update2026-09-24 01:01:06
12026-06-11daily-update2026-06-16 05:10:25

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 45.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218616-001MINOXIDIL (FOR MEN)MINOXIDIL5%AEROSOL, FOAM / TOPICAL2024-04-22
A218616-002MINOXIDIL (FOR WOMEN)MINOXIDIL5%AEROSOL, FOAM / TOPICAL2024-04-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-11-14 07:37:172026-10A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22d4dbc9d85df4…
2026-11-14 07:37:172026-10A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22d4dbc9d85df4…
2026-10-15 13:18:302026-09A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22c2088c7a36db…
2026-10-15 13:18:302026-09A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22c2088c7a36db…
2026-09-14 22:38:342026-08A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-2284e616aacf4f…
2026-08-18 06:07:402026-07A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-228072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218616-001MINOXIDIL (FOR MEN)5%AEROSOL, FOAM / TOPICAL2024-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218616-002MINOXIDIL (FOR WOMEN)5%AEROSOL, FOAM / TOPICAL2024-04-22a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5bf6f828-e3d3-858d-e063-6294a90ad4725406743a-b688-346e-e063-6294a90a2caf2026-09-20WarningsExact identifier
spl set id: 5406743a-b688-346e-e063-6294a90a2caf

Reported adverse events (FAERS/openFDA)#

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