FDA.reportPublic FDA data

MINOXIDIL (FOR MEN) - FlexiGo Inc

Manufacturer
FlexiGo Inc
Effective date
2026-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-11 05:11:18

Label at a glance#

ProductMINOXIDIL (FOR MEN)
Active ingredientMINOXIDIL
Label structure12 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

DOSAGE&ADMINISTRATION SECTIONDOSAGE&ADMINISTRATION SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC-ACTIVE INGREDIENT SECTIONOTC-ACTIVE INGREDIENT SECTION

OTC - ASK DOCTOR SECTION

OTC-ASK DOCTOR SECTIONOTC-ASK DOCTOR 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 CHILDREN SECTIONOTC-KEEP OUT OF REACH OF CHILDREN SECTION

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 USING SECTIONOTC-WHEN USING SECTION

WARNINGS SECTION

WARNINGS SECTIONWARNINGS SECTION

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTIONINACTIVE INGREDIENT SECTION

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTIONINDICATIONS & USAGE SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANLPACKAGE LABEL.PRINCIPAL DISPLAY PANL

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
85524-261185524-2611-1, 85524-2611-2

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
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
ISOBUTANEBXR49TP611IACT
WATER059QF0KO0RIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
PROPANET75W9911L6IACT
BUTANE6LV4FOR43RIACT
POLYSORBATE 60CAL22UVI4MIACT
STEARYL ALCOHOL2KR89I4H1YIACT
MINOXIDIL5965120SH1ACTIB

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 44.

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
2026-10-15 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
MINOXIDIL (FOR MEN)MINOXIDILFlexiGo Inc53793182-8a03-1b0f-e063-6294a90acca62026-06-04WarningsExact identifier
ndc (package): 85524-2611-1
ndc (package): 85524-2611-2
ndc (product): 85524-2611
ndc11 (package): 85524261102
ndc11 (package): 85524261101
spl id: 53793182-8a04-1b0f-e063-6294a90acca6
spl set id: 53793182-8a03-1b0f-e063-6294a90acca6

Reported adverse events (FAERS/openFDA)#

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