5% Minoxidil Hair Growth Topical Solution

Product NDC
85304-018
11-digit product format
853040018
Labeler code
85304
Product ID
85304-018_3e6949f0-7c67-1d5b-e063-6294a90a239a
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangzhou Borderless Technology Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-09
Substance
BIOTIN; MINOXIDIL
Active strength
.5; 5 g/100mL; g/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% Minoxidil Hair Growth Topical Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIOTIN.5 g/100mL
MINOXIDIL5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6SO6U10H04, 5965120SH1
Rxcui2691097

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85304-018-015% Minoxidil Hair Growth Topical Solution3 in 1 PACKAGELIQUID32
85304-018-015% Minoxidil Hair Growth Topical Solution80 mL in 1 BOTTLELIQUID802
85304-018-025% Minoxidil Hair Growth Topical Solution6 in 1 PACKAGELIQUID62
85304-018-025% Minoxidil Hair Growth Topical Solution80 mL in 1 BOTTLELIQUID802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691097biotin 0.5 % / minoxidil 5 % Topical SolutionPSN3e569e69-55b9-1d01-e063-6294a90a88ed2
2691097biotin 5 MG/ML / minoxidil 50 MG/ML Topical SolutionSCD3e569e69-55b9-1d01-e063-6294a90a88ed2
2691097biotin 0.5 % / minoxidil 5 % Topical SolutionSY3e569e69-55b9-1d01-e063-6294a90a88ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85304-018-01853040018013 BOTTLE in 1 PACKAGE (85304-018-01) / 80 mL in 1 BOTTLE3 bottle2025-09-09NoNoCurrent
85304-018-02853040018026 BOTTLE in 1 PACKAGE (85304-018-02) / 80 mL in 1 BOTTLE6 bottle2025-09-09NoNoCurrent