FDA.reportPublic FDA data

5% Minoxidil with Biotin

Product NDC
85304-001
Requested package NDC
85304-001-06
11-digit product format
853040001
Labeler code
85304
Product ID
85304-001_300bc4e7-e796-4f32-e063-6394a90a1e67
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Guangzhou Borderless Technology Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-11
Substance
BIOTIN; MINOXIDIL
Active strength
.2; 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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5% Minoxidil with BiotinMINOXIDILGuangzhou Borderless Technology Co., Ltd.300bc4e7-e795-4f32-e063-6394a90a1e672025-03-11WarningsExact identifier
ndc (package): 85304-001-06
ndc (product): 85304-001
ndc11 (package): 85304000106

Additional Listing Data#

Finished product
Yes
Brand name base
5% Minoxidil with Biotin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIOTIN.2 g/100mL
MINOXIDIL5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2707693Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
300bc4e7-e795-4f32-e063-6394a90a1e67Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85304-001-025% Minoxidil with Biotin2 in 1 BOXSOLUTION21
85304-001-025% Minoxidil with Biotin60 mL in 1 BOTTLESOLUTION601
85304-001-045% Minoxidil with Biotin4 in 1 BOXSOLUTION41
85304-001-045% Minoxidil with Biotin60 mL in 1 BOTTLESOLUTION601
85304-001-065% Minoxidil with Biotin60 mL in 1 BOTTLESOLUTION601
85304-001-065% Minoxidil with Biotin6 in 1 BOXSOLUTION61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85304-0015% MINOXIDIL WITH BIOTIN (MINOXIDIL) SOLUTION [GUANGZHOU BORDERLESS TECHNOLOGY CO., LTD.]1Current NDC, 6 package rows20250312_300bc4e7-e795-4f32-e063-6394a90a1e67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2707693biotin 0.2 % / minoxidil 5 % Topical SolutionPSN300bc4e7-e795-4f32-e063-6394a90a1e671
2707693biotin 2 MG/ML / minoxidil 50 MG/ML Topical SolutionSCD300bc4e7-e795-4f32-e063-6394a90a1e671
2707693biotin 0.2 % / minoxidil 5 % Topical SolutionSY300bc4e7-e795-4f32-e063-6394a90a1e671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85304-001-06853040001066 BOTTLE in 1 BOX (85304-001-06) / 60 mL in 1 BOTTLE6 bottle2025-03-11NoNoCurrent