5%MinoxidilHairgrowthSpray

Product NDC
84778-109
11-digit product format
847780109
Labeler code
84778
Product ID
84778-109_425d93d4-e5b1-3635-e063-6394a90a24f1
Type
HUMAN OTC DRUG
Nonproprietary name
5%MinoxidilHairgrowthSpray
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Guangzhou Yixin Cross-border E-commerce Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-22
Substance
MINOXIDIL
Active strength
5 mg/100mL
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
5%MinoxidilHairgrowthSpray
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84778-109-015%MinoxidilHairgrowthSpray1 in 1 BOXSHAMPOO13
84778-109-015%MinoxidilHairgrowthSpray60 mL in 1 BOTTLESHAMPOO603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84778-109-01847780109011 BOTTLE in 1 BOX (84778-109-01) / 60 mL in 1 BOTTLE1 bottle2025-08-22NoNoHistorical