Hair regrowth treatment

Product NDC
81653-005
11-digit product format
816530005
Labeler code
81653
Product ID
81653-005_529d3660-75b4-6036-e063-6294a90a3170
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangzhou Jianyuan Biological Technology.Co.,Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-20
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hair regrowth treatmentMINOXIDILGuangzhou Jianyuan Biological Technology.Co.,Ltdeb87ff2d-7708-4c4d-e053-2a95a90ac72b2026-05-24WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

For external use only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application. May be harmful if used when pregnant or breast-feeding.

warnings and cautions

When using this product do not apply on other parts of the body avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. Results may occur at 2 months with twice a day usage.For some men, youmay need to use this product for at least 4 months before you see results. the amount of hair regrowth is different for each person. This product will not work for all men and women

Additional Listing Data#

Finished product
Yes
Brand name base
Hair regrowth treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui645146

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81653-005-01Hair regrowth treatment3 in 1 BOXLIQUID34
81653-005-01Hair regrowth treatment60 mL in 1 BOTTLE, SPRAYLIQUID604
81653-005-02Hair regrowth treatment60 mL in 1 BOTTLE, SPRAYLIQUID604
81653-005-02Hair regrowth treatment3 in 1 BOXLIQUID34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81653-005HAIR REGROWTH TREATMENT (MINOXIDIL) LIQUID [GUANGZHOU JIANYUAN BIOLOGICAL TECHNOLOGY.CO.,LTD]3Current NDC, Legacy NDC, 4 package rows20250212_eb87ff2d-7708-4c4d-e053-2a95a90ac72b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSNeb87ff2d-7708-4c4d-e053-2a95a90ac72b4
645146minoxidil 50 MG/ML Topical FoamSCDeb87ff2d-7708-4c4d-e053-2a95a90ac72b4
645146minoxidil 5 % Topical FoamSYeb87ff2d-7708-4c4d-e053-2a95a90ac72b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81653-005-01816530005013 BOTTLE, SPRAY in 1 BOX (81653-005-01) / 60 mL in 1 BOTTLE, SPRAY2022-10-250000-00-00NoNoCurrent
81653-005-02816530005023 BOTTLE, SPRAY in 1 BOX (81653-005-02) / 60 mL in 1 BOTTLE, SPRAY2022-10-250000-00-00NoNoCurrent