FDA.reportPublic FDA data

5% Minoxidil Hair Growth Foam

Product NDC
85304-019
11-digit product format
853040019
Labeler code
85304
Product ID
85304-019_3feb9ac0-2cd2-9db2-e063-6394a90acab9
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Guangzhou Borderless Technology Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-29
Substance
BIOTIN; MINOXIDIL
Active strength
.5; 5 g/100g; g/100g
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 Foam
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6SO6U10H04, 5965120SH1
Rxcui2723100

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85304-019-015% Minoxidil Hair Growth Foam60 g in 1 BOTTLEAEROSOL, FOAM601
85304-019-015% Minoxidil Hair Growth Foam4 in 1 PACKAGEAEROSOL, FOAM41
85304-019-025% Minoxidil Hair Growth Foam8 in 1 PACKAGEAEROSOL, FOAM81
85304-019-025% Minoxidil Hair Growth Foam60 g in 1 BOTTLEAEROSOL, FOAM601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723100biotin 0.5 % / minoxidil 5 % Topical FoamPSN3feb9ac0-2cd1-9db2-e063-6394a90acab91
2723100biotin 5 MG/ML / minoxidil 50 MG/ML Topical FoamSCD3feb9ac0-2cd1-9db2-e063-6394a90acab91
2723100biotin 0.5 % / minoxidil 5 % Topical FoamSY3feb9ac0-2cd1-9db2-e063-6394a90acab91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85304-019-01853040019014 BOTTLE in 1 PACKAGE (85304-019-01) / 60 g in 1 BOTTLE4 bottle2025-09-29NoNoCurrent
85304-019-02853040019028 BOTTLE in 1 PACKAGE (85304-019-02) / 60 g in 1 BOTTLE8 bottle2025-09-29NoNoCurrent