FDA.reportPublic FDA data

5% Minoxidil Hair Growth Foam

Product NDC
85304-019
Requested package NDC
85304-019-02
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
MINOXIDIL.5 g/100g
BIOTIN5 g/100g

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
2723100Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3feb9ac0-2cd1-9db2-e063-6394a90acab9Available on FDA.report

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

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 FoamMINOXIDILGuangzhou Borderless Technology Co., Ltd.3feb9ac0-2cd1-9db2-e063-6394a90acab92025-09-29WarningsExact identifier
ndc (package): 85304-019-02
ndc (product): 85304-019
ndc11 (package): 85304001902

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
85304-019-02853040019028 BOTTLE in 1 PACKAGE (85304-019-02) / 60 g in 1 BOTTLE8 bottle2025-09-29NoNoCurrent