FDA.reportPublic FDA data

2% Minoxidil Hair Regrowth Foam

Product NDC
85038-004
11-digit product format
850380004
Labeler code
85038
Product ID
85038-004_4e77eea7-889c-be81-e063-6294a90a2697
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Lianjiang Shanlilai E-commerce Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-11
Substance
BIOTIN; MINOXIDIL
Active strength
.5; 2 g/100g; g/100g
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
2% Minoxidil Hair Regrowth Foam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIOTIN.5 g/100g
MINOXIDIL2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6SO6U10H04, 5965120SH1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85038-004-012% Minoxidil Hair Regrowth Foam1 in 1 PACKAGEAEROSOL, FOAM12
85038-004-012% Minoxidil Hair Regrowth Foam60 g in 1 BOTTLEAEROSOL, FOAM602
85038-004-022% Minoxidil Hair Regrowth Foam2 in 1 PACKAGEAEROSOL, FOAM22
85038-004-022% Minoxidil Hair Regrowth Foam60 g in 1 BOTTLEAEROSOL, FOAM602
85038-004-032% Minoxidil Hair Regrowth Foam3 in 1 PACKAGEAEROSOL, FOAM32
85038-004-032% Minoxidil Hair Regrowth Foam60 g in 1 BOTTLEAEROSOL, FOAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85038-0042% MINOXIDIL HAIR REGROWTH FOAM (MINOXIDIL) AEROSOL, FOAM [LIANJIANG SHANLILAI E-COMMERCE CO., LTD.]1Current NDC, 6 package rows20241213_28fcc94f-5206-5f7d-e063-6394a90a7bcc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85038-004-01850380004011 BOTTLE in 1 PACKAGE (85038-004-01) / 60 g in 1 BOTTLE1 bottle2024-12-11NoNoHistorical
85038-004-02850380004022 BOTTLE in 1 PACKAGE (85038-004-02) / 60 g in 1 BOTTLE2 bottle2024-12-11NoNoHistorical
85038-004-03850380004033 BOTTLE in 1 PACKAGE (85038-004-03) / 60 g in 1 BOTTLE3 bottle2024-12-11NoNoHistorical