NALIOPI 5% minoxidil with biotin topical solution

Product NDC
85304-026
11-digit product format
853040026
Labeler code
85304
Product ID
85304-026_4b9e16f0-3e3a-03f2-e063-6394a90a19df
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
2026-02-25
Substance
BIOTIN; MINOXIDIL
Active strength
.002; .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

Additional Listing Data#

Finished product
Yes
Brand name base
NALIOPI 5% minoxidil with biotin topical solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIOTIN.002 g/mL
MINOXIDIL.05 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6SO6U10H04, 5965120SH1
Rxcui2707693

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85304-026-01NALIOPI 5% minoxidil with biotin topical solution3 in 1 PACKAGELIQUID31
85304-026-01NALIOPI 5% minoxidil with biotin topical solution60 mL in 1 BOTTLELIQUID601
85304-026-02NALIOPI 5% minoxidil with biotin topical solution6 in 1 PACKAGELIQUID61
85304-026-02NALIOPI 5% minoxidil with biotin topical solution60 mL in 1 BOTTLELIQUID601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2707693biotin 0.2 % / minoxidil 5 % Topical SolutionPSN4b9e16f0-3e39-03f2-e063-6394a90a19df1
2707693biotin 2 MG/ML / minoxidil 50 MG/ML Topical SolutionSCD4b9e16f0-3e39-03f2-e063-6394a90a19df1
2707693biotin 0.2 % / minoxidil 5 % Topical SolutionSY4b9e16f0-3e39-03f2-e063-6394a90a19df1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85304-026-01853040026013 BOTTLE in 1 PACKAGE (85304-026-01) / 60 mL in 1 BOTTLE3 bottle2026-02-25NoNoCurrent
85304-026-02853040026026 BOTTLE in 1 PACKAGE (85304-026-02) / 60 mL in 1 BOTTLE6 bottle2026-02-25NoNoCurrent