Minoxidil

Product NDC
70550-116
11-digit product format
705500116
Labeler code
70550
Product ID
70550-116_9a10e5d1-3def-4521-bf64-a8e3029a73a2
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Keranique
Application
ANDA208092
Marketing category
ANDA
Marketing start
2024-03-15
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui645146

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70550-116-02Minoxidil1 in 1 PACKAGEAEROSOL, FOAM16
70550-116-02Minoxidil60 g in 1 CANAEROSOL, FOAM606
70550-116-20Minoxidil60 g in 1 CANAEROSOL, FOAM606
70550-116-20Minoxidil2 in 1 PACKAGEAEROSOL, FOAM26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70550-116MINOXIDIL AEROSOL, FOAM [PROFECTUS BEAUTY, LLC]5Current NDC, 4 package rows20240316_4af782f4-68d5-4338-a0a6-85d11a23ce98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSN4af782f4-68d5-4338-a0a6-85d11a23ce986
645146minoxidil 50 MG/ML Topical FoamSCD4af782f4-68d5-4338-a0a6-85d11a23ce986
645146minoxidil 5 % Topical FoamSY4af782f4-68d5-4338-a0a6-85d11a23ce986

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70550-116-02705500116021 CAN in 1 PACKAGE (70550-116-02) / 60 g in 1 CAN1 can2024-03-15NoNoHistorical
70550-116-20705500116202 CAN in 1 PACKAGE (70550-116-20) / 60 g in 1 CAN2 can2024-03-15NoNoHistorical