FDA.reportPublic FDA data

Minoxidil Hair Regrowth Treatment

Product NDC
85636-024
Requested package NDC
85636-024-01
11-digit product format
856360024
Labeler code
85636
Product ID
85636-024_5278ed66-2937-3cac-e063-6394a90aa644
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Shenzhen Earth Surface Trading Co., Ltd.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-01
Substance
MINOXIDIL
Active strength
5 g/100mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Minoxidil Hair Regrowth Treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5965120SH1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1537948Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
527902b1-2018-4546-e063-6394a90a7052Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85636-024-01Minoxidil Hair Regrowth Treatment60 mL in 1 BOTTLELIQUID601

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 14 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders Itchy Scalp 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company157c3f81-f37e-4dab-b724-50fe0d9e1a262025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Conditioner Smooth and SilkyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company41709710-539c-3119-e054-00144ff88e882025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Dry Scalp Care Hair and Scalp ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company42620236-17ef-5c70-e054-00144ff88e882025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Hair and Scalp Conditioner Green ApplePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4534c7a7-bc4b-3851-e054-00144ff88e882025-12-18WarningsExact identifier
application number: M032
Head and Shoulders MEN Old Spice Pure SportPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7bbfc667-bf9b-08c2-e053-2a91aa0a80092025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Royal Oils Daily Moisture ScalpPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7b1f81e1-1fee-5be2-e053-2a91aa0aa0632025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Royal Oils Instant Soothe ScalpPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a2025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Coconut Daily Hair and Scalp ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7cc10c1b-fe0b-7d4c-e053-2a91aa0a23772025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Men Advanced Series Swagger Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7d3cdf44-ae1d-fed5-e053-2a91aa0a30212025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Supreme Detox and HydratePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company8659218e-cb8d-bb44-e053-2a91aa0ae37b2025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Supreme Soothe and StrengthenPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86972263-dcef-358f-e053-2991aa0a734f2025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Supreme Color ProtectPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company8697a03b-7050-3a49-e053-2a91aa0a72712025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Supreme Detox and Hydrate ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86ab72bc-4e9d-0075-e053-2a91aa0a11352025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Supreme Soothe and Strengthen ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86abfdc2-d55b-4adb-e053-2991aa0a54b12025-12-18WarningsExact identifier
application number: M032
Head and Shoulders MEN Advanced Series Bourbon 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company98480eaa-6798-4efe-e053-2a95a90a869f2025-12-18WarningsExact identifier
application number: M032
Head and Shoulders MEN Advanced Series Sandalwood 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company9858f681-1aca-e481-e053-2a95a90a869d2025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Apple Cider Vinegar 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyb698b310-a794-e7f3-e053-2a95a90a47c42025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Clinical Dandruff Defense Dry Scalp RescuePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc7bc3942-6943-2ea5-e053-2a95a90a42a92025-12-18WarningsExact identifier
application number: M032
Royal Oils by head and shoulders Moisture Renewal Scalp Balancing ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc95e82e4-74fb-9dbf-e053-2a95a90a93e52025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Moisturizing Avocado OilPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyd08969cb-24ca-c49c-e053-2a95a90a71d12025-12-18WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1537948minoxidil 5 % Topical SprayPSN527902b1-2018-4546-e063-6394a90a70521
1537948minoxidil 50 MG/ML Topical SpraySCD527902b1-2018-4546-e063-6394a90a70521
1537948minoxidil 5 % Topical SpraySY527902b1-2018-4546-e063-6394a90a70521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85636-024-018563600240160 mL in 1 BOTTLE (85636-024-01) 60 ml2026-05-01NoNoCurrent