FDA.reportPublic FDA data

Minoxidil Hair Regrowth Solution

Product NDC
85038-007
11-digit product format
850380007
Labeler code
85038
Product ID
85038-007_384db88f-95fd-3642-e063-6394a90a9123
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Lianjiang Shanlilai E-commerce Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-24
Substance
MINOXIDIL
Active strength
5 g/100mL
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
Minoxidil Hair Regrowth Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311724

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
85038-007-01Minoxidil Hair Regrowth Solution60 mL in 1 BOTTLESOLUTION601
85038-007-01Minoxidil Hair Regrowth Solution1 in 1 PACKAGESOLUTION11
85038-007-02Minoxidil Hair Regrowth Solution60 mL in 1 BOTTLESOLUTION601
85038-007-02Minoxidil Hair Regrowth Solution2 in 1 PACKAGESOLUTION21
85038-007-03Minoxidil Hair Regrowth Solution60 mL in 1 BOTTLESOLUTION601
85038-007-03Minoxidil Hair Regrowth Solution3 in 1 PACKAGESOLUTION31
85038-007-04Minoxidil Hair Regrowth Solution60 mL in 1 BOTTLESOLUTION601
85038-007-04Minoxidil Hair Regrowth Solution4 in 1 PACKAGESOLUTION41

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN384db88f-95fc-3642-e063-6394a90a91231
311724minoxidil 50 MG/ML Topical SolutionSCD384db88f-95fc-3642-e063-6394a90a91231
311724minoxidil 3 GM per 60 ML Topical SolutionSY384db88f-95fc-3642-e063-6394a90a91231
311724minoxidil 5 % Topical SolutionSY384db88f-95fc-3642-e063-6394a90a91231
311724minoxidil 5 GM per 100 ML Topical SolutionSY384db88f-95fc-3642-e063-6394a90a91231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85038-007-01850380007011 BOTTLE in 1 PACKAGE (85038-007-01) / 60 mL in 1 BOTTLE1 bottle2025-06-24NoNoHistorical
85038-007-02850380007022 BOTTLE in 1 PACKAGE (85038-007-02) / 60 mL in 1 BOTTLE2 bottle2025-06-24NoNoHistorical
85038-007-03850380007033 BOTTLE in 1 PACKAGE (85038-007-03) / 60 mL in 1 BOTTLE3 bottle2025-06-24NoNoHistorical
85038-007-04850380007044 BOTTLE in 1 PACKAGE (85038-007-04) / 60 mL in 1 BOTTLE4 bottle2025-06-24NoNoHistorical