FDA.reportPublic FDA data

Anti Dandruff

Product NDC
85593-121
11-digit product format
855930121
Labeler code
85593
Product ID
85593-121_599f2cce-0c28-d425-e063-6394a90a1565
Type
HUMAN OTC DRUG
Nonproprietary name
Ketoconazole
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Guangzhou ChuanMa International Trading Co.,Ltd.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-22
Substance
KETOCONAZOLE
Active strength
1 g/100mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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
Anti Dandruff
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R9400W927IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240812Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
599f2cce-0c27-d425-e063-6394a90a1565Available on FDA.report

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85593-121-0185593012101230 mL in 1 BOTTLE (85593-121-01) 230 ml2026-08-22NoNoCurrent