Minoxidil

Product NDC
80855-201
11-digit product format
808550201
Labeler code
80855
Product ID
80855-201_3a228a78-03ce-991c-e063-6394a90adfa8
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Virtue Labs, LLC
Application
ANDA209074
Marketing category
ANDA
Marketing start
2020-12-23
Substance
MINOXIDIL
Active strength
50 mg/g
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Minoxidil
Brand name suffix
(for Women)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui645146

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80855-201-05Minoxidil (for Women)60 g in 1 CANAEROSOL, FOAM602
80855-201-05Minoxidil (for Women)1 in 1 PACKAGEAEROSOL, FOAM12
80855-201-06Minoxidil (for Women)2 in 1 PACKAGEAEROSOL, FOAM22
80855-201-06Minoxidil (for Women)60 g in 1 CANAEROSOL, FOAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80855-201MINOXIDIL (FOR WOMEN) (MINOXIDIL) AEROSOL, FOAM [VIRTUE LABS, LLC]1Current NDC, Legacy NDC, 4 package rows20210121_85a9d343-1135-4296-96b5-fabab6b834f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSN85a9d343-1135-4296-96b5-fabab6b834f92
645146minoxidil 50 MG/ML Topical FoamSCD85a9d343-1135-4296-96b5-fabab6b834f92
645146minoxidil 5 % Topical FoamSY85a9d343-1135-4296-96b5-fabab6b834f92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80855-201-05808550201051 CAN in 1 PACKAGE (80855-201-05) / 60 g in 1 CAN1 can2020-12-230000-00-00NoNoCurrent
80855-201-06808550201062 CAN in 1 PACKAGE (80855-201-06) / 60 g in 1 CAN2 can2020-12-230000-00-00NoNoCurrent