RootVive Mens Hair Regrowth Treatment Extra Strength Minoxidil

Product NDC
87663-962
11-digit product format
876630962
Labeler code
87663
Product ID
87663-962_5124055f-976e-d787-e063-6394a90aac51
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
TrueRoot Labs LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2026-04-17
Substance
MINOXIDIL
Active strength
50 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RootVive Mens Hair Regrowth Treatment Extra Strength Minoxidil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87663-962-00RootVive Mens Hair Regrowth Treatment Extra Strength Minoxidil1 in 1 BOXSOLUTION11
87663-962-00RootVive Mens Hair Regrowth Treatment Extra Strength Minoxidil60 mL in 1 BOTTLE, DROPPERSOLUTION601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNde865d37-d99f-4f9d-8c09-472a308e2e911
311724minoxidil 50 MG/ML Topical SolutionSCDde865d37-d99f-4f9d-8c09-472a308e2e911
311724minoxidil 3 GM per 60 ML Topical SolutionSYde865d37-d99f-4f9d-8c09-472a308e2e911
311724minoxidil 5 % Topical SolutionSYde865d37-d99f-4f9d-8c09-472a308e2e911
311724minoxidil 5 GM per 100 ML Topical SolutionSYde865d37-d99f-4f9d-8c09-472a308e2e911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87663-962-00876630962001 BOTTLE, DROPPER in 1 BOX (87663-962-00) / 60 mL in 1 BOTTLE, DROPPER2026-04-17NoNoHistorical