Mens Extra Strength Minoxidil Hair Growth Treatment

Product NDC
87616-969
11-digit product format
876160969
Labeler code
87616
Product ID
87616-969_50ab4a95-ef37-f7ca-e063-6394a90a61b8
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Hairmax International, LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2026-03-09
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
Mens Extra Strength Minoxidil Hair Growth Treatment
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
87616-969-00Mens Extra Strength Minoxidil Hair Growth Treatment60 mL in 1 BOTTLE, DROPPERSOLUTION602
87616-969-00Mens Extra Strength Minoxidil Hair Growth Treatment1 in 1 BOXSOLUTION12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN7ee426fe-7a13-4327-b333-9651d6871a732
311724minoxidil 50 MG/ML Topical SolutionSCD7ee426fe-7a13-4327-b333-9651d6871a732
311724minoxidil 3 GM per 60 ML Topical SolutionSY7ee426fe-7a13-4327-b333-9651d6871a732
311724minoxidil 5 % Topical SolutionSY7ee426fe-7a13-4327-b333-9651d6871a732
311724minoxidil 5 GM per 100 ML Topical SolutionSY7ee426fe-7a13-4327-b333-9651d6871a732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87616-969-00876160969001 BOTTLE, DROPPER in 1 BOX (87616-969-00) / 60 mL in 1 BOTTLE, DROPPER2026-03-09NoNoHistorical