FDA.reportPublic FDA data

MINOXIDIL

Manufacturer
FlexiGo Inc
Effective date
2025-09-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:14:00

Label at a glance#

ProductMINOXIDIL
Active ingredientMINOXIDIL
Label structure10 sections

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

OTC-Active IngredientOTC-Active IngredientOTC Active IngredientOTC Active Ingredient

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-PurposeOTC-Purpose

DOSAGE & ADMINISTRATION SECTION

DIRECTIONSDIRECTIONS

INDICATIONS & USAGE SECTION

UsesUses

OTC - WHEN USING SECTION

OTC-When usingOTC-When using

OTC - STOP USE SECTION

OTC-STOP USE SECTIONOTC-STOP USE SECTION

STORAGE AND HANDLING SECTION

OTHER INFORMATIONOTHER INFORMATION

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTSINACTIVE INGREDIENTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Heading Package LabelHeading Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1537948minoxidil 5 % Topical SprayPSN2
1537948minoxidil 50 MG/ML Topical SpraySCD2
1537948minoxidil 5 % Topical SpraySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MINOXIDIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85524-2509-6MINOXIDIL60 mL in 1 BOTTLELIQUID602

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
85524-250985524-2509-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MINOXIDIL5965120SH1ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
GINGERC5529G5JPQIACT
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
XANTHAN GUMTTV12P4NEEIACT
CASTOR OILD5340Y2I9GIACT
ROSEMARY OIL8LGU7VM393IACT
PANAX NOTOGINSENG ROOTGQX1C1175UIACT
BIOTIN6SO6U10H04IACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

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
3e1b966f-8389-ef03-e063-6294a90a83303a6ed11d-1ac5-1211-e063-6394a90a518b2025-09-06Exact identifier
spl id: 3e1b966f-8389-ef03-e063-6294a90a8330
spl set id: 3a6ed11d-1ac5-1211-e063-6394a90a518b

Reported adverse events (FAERS/openFDA)#

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