FDA.reportPublic FDA data

Anti Dandruff

Product NDC
85593-033
11-digit product format
855930033
Labeler code
85593
Product ID
85593-033_55a48fc6-194b-66ea-e063-6294a90a3501
Type
HUMAN OTC DRUG
Nonproprietary name
KETOCONAZOLE
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Guangzhou ChuanMa International Trading Co.,Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-14
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
4cfe234c-49c0-18e8-e063-6294a90a0b1dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85593-033-01Anti Dandruff200 mL in 1 BOTTLESHAMPOO2001

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 30 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TolnaftateFOOT ODOR CONTROL SPRAYHEBc585605b-ecb8-4dd8-9205-a9be02d751fa2025-11-03WarningsExact identifier
application number: M005
Premier Solutions Antifungal Tolnaftate LiquidTOLNAFTATEPremier Brands of America, Inc.e1971c1c-5687-577b-e053-2a95a90ad95f2025-11-03WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYPremier Brands of America Inc.3803c643-35d1-06d4-e063-6294a90ac6f62025-11-03WarningsExact identifier
application number: M005
Anti-fungal Powder Miconazole NitrateMICONAZOLE NITRATEMeijer Distribution Inc03fd069d-685d-b8ac-e063-6394a90a31f82025-10-31WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYPremier Brands of America Inc.7a6a63cd-e87d-4229-8acf-b65d63909eb62025-10-31WarningsExact identifier
application number: M005
AzolenMICONAZOLE NITRATEStratus Pharmaceuticals, Inc.9c2574f3-3be4-405a-9c87-943dc6ef87772025-10-30WarningsExact identifier
application number: M005
Family Care AntifungalCLOTRIMAZOLEUnited Exchange Corp.63255079-ecf1-1e77-e053-2a91aa0a7b6c2025-10-30WarningsExact identifier
application number: M005
Miconazorb AFMICONAZOLE NITRATEAmerisourceBergen Drug Corporation13a20d21-42d5-fe56-e063-6394a90aaf572025-10-30WarningsExact identifier
application number: M005
Antifungal Liquid ContinuousMICONAZOLE NITRATEFamily Dollar Services, Inc17cc4601-f946-df8b-e063-6394a90a38972025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYARMY & AIR FORCE EXCHANGE SERVICE932b1be8-3dbb-49ae-822a-c44a24fbe36a2025-10-30WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYGEISS, DESTIN AND DUNN, INC.c367c2e8-5423-bf01-e053-2a95a90ab8e92025-10-30WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYHarris Teeter, LLC636b0d6f-4e36-4c96-9e71-7bfdebb7f3cb2025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYHarris Teeter, LLCf140e9bb-507b-4048-8b7b-8cc51b6a497d2025-10-30WarningsExact identifier
application number: M005
HEB Athlete Foot AntifungalMICONAZOLE NITRATEHEB2e204111-b5d3-0220-e063-6294a90a67bb2025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL SPRAY LIQUIDKroger Co.0cfebac3-684d-4599-b75f-9a82708db7172025-10-30WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYKroger Co.86bdf8a6-3a1f-457b-e053-2991aa0a58102025-10-30WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATE POWDER SPRAYKroger Co.f5c8dccd-8e69-6a01-e053-2a95a90a69722025-10-30WarningsExact identifier
application number: M005
TolnafateFOOT AND SNEAKER SPRAYKroger Co.72243b08-47cf-4db3-b834-b762b7f0ccf92025-10-30WarningsExact identifier
application number: M005
Anti-Fungal PowderMICONAZOLE NITRATEThe Kroger Co.209cd0ed-3029-9137-e063-6394a90aa93d2025-10-30WarningsExact identifier
application number: M005
Antifungal Miconazole Liquid ContinuousMICONAZOLE NITRATEMeijer Distribution Inc030f2a31-334b-a6d8-e063-6394a90a98fc2025-10-30WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240812ketoconazole 1 % Medicated ShampooPSN4cfe234c-49c0-18e8-e063-6294a90a0b1d1
240812ketoconazole 10 MG/ML Medicated ShampooSCD4cfe234c-49c0-18e8-e063-6294a90a0b1d1
240812ketoconazole 1 % Medicated ShampooSY4cfe234c-49c0-18e8-e063-6294a90a0b1d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85593-033-0185593003301200 mL in 1 BOTTLE (85593-033-01) 200 ml2026-03-14NoNoCurrent