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
MINOXIDIL; BIOTIN
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
MINOXIDIL5 g/100mL
BIOTIN.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5965120SH1Internal UNII lookup
6SO6U10H04Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2691097Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e569e69-55b9-1d01-e063-6294a90a88edAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5% Minoxidil Hair Growth Topical SolutionMINOXIDILGuangzhou Borderless Technology Co., Ltd.3e569e69-55b9-1d01-e063-6294a90a88ed2025-09-09WarningsExact identifier
ndc (product): 85304-018

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