AGIKENB 5% minoxidil with biotin topical solution

Product NDC
85304-029
11-digit product format
853040029
Labeler code
85304
Product ID
85304-029_4dc2be0b-59f2-50fd-e063-6294a90a6f54
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
2026-03-24
Substance
BIOTIN; MINOXIDIL
Active strength
.005; .05 g/mL; g/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
AGIKENB 5% minoxidil with biotin topical solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIOTIN.005 g/mL
MINOXIDIL.05 g/mL

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
2715603Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4dc2be0b-59f1-50fd-e063-6294a90a6f54Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85304-029-01AGIKENB 5% minoxidil with biotin topical solution4 in 1 PACKAGESOLUTION41
85304-029-01AGIKENB 5% minoxidil with biotin topical solution60 mL in 1 BOTTLESOLUTION601
85304-029-02AGIKENB 5% minoxidil with biotin topical solution8 in 1 PACKAGESOLUTION81
85304-029-02AGIKENB 5% minoxidil with biotin topical solution60 mL in 1 BOTTLESOLUTION601

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
AGIKENB 5% minoxidil with biotin topical solutionMINOXIDILGuangzhou Borderless Technology Co., Ltd.4dc2be0b-59f1-50fd-e063-6294a90a6f542026-03-24WarningsExact identifier
ndc (product): 85304-029

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2715603biotin 0.5 % / minoxidil 5 % Topical SprayPSN4dc2be0b-59f1-50fd-e063-6294a90a6f541
2715603biotin 5 MG/ML / minoxidil 50 MG/ML Topical SpraySCD4dc2be0b-59f1-50fd-e063-6294a90a6f541
2715603biotin 0.5 % / minoxidil 5 % Topical SpraySY4dc2be0b-59f1-50fd-e063-6294a90a6f541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85304-029-01853040029014 BOTTLE in 1 PACKAGE (85304-029-01) / 60 mL in 1 BOTTLE4 bottle2026-03-24NoNoCurrent
85304-029-02853040029028 BOTTLE in 1 PACKAGE (85304-029-02) / 60 mL in 1 BOTTLE8 bottle2026-03-24NoNoCurrent