FDA.reportPublic FDA data

Anti Dandruff

Product NDC
85593-033
11-digit product format
855930033
Labeler code
85593
Product ID
85593-033_4cfe234c-49c1-18e8-e063-6294a90a0b1d
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

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 1 of 52 · 1,022 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DrAny NAIL FUNGUS TREATMENTUNDECYLENIC ACID, TOLNAFTATEHong Kong Juxin Negosyo Kag Komersyo Co., Limited59ef412b-fc7b-0a84-e063-6394a90abf252026-08-26WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
application number: M005
Okkazhie WART REMOVER40% SALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.59c2d759-d1e9-6c9d-e063-6294a90a04db2026-08-23WarningsExact identifier
application number: M005
1% ketoconazole anti dandruff1% KETOCONAZOLE ANTI DANDRUFF SHAMPOOFast Sold LLC7bb3598c-9597-4f3d-9a68-bd95657379282026-08-22WarningsExact identifier
application number: M005
JELVOXA ANTIFUNGALUNDECYLENIC ACIDWuhan Ruihengjie Technology Co., Ltd.59a2f16e-ef72-f1cb-e063-6394a90abb282026-08-22WarningsExact identifier
application number: M005
Viachs ANTIFUNGAL CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.598b7e0c-c76d-2f56-e063-6394a90a70532026-08-21WarningsExact identifier
application number: M005
BlissCare tea tree oil antifungalTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58f9ff8c-d75a-ad1d-e063-6294a90af3dc2026-08-21WarningsExact identifier
application number: M005
GPPEE TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.598d05bc-459d-71cf-e063-6394a90a19322026-08-21WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATEGentell LLC596d590b-e7ff-4be3-e063-6294a90a871d2026-08-20WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f9f2a-7857-0752-e063-6394a90af8de2026-08-19WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595fd84a-fead-3818-e063-6394a90aa4f12026-08-19WarningsExact identifier
application number: M005
WISH HAND SANITIZER vanilla creamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594bb903-2406-abb9-e063-6294a90a1cee2026-08-18WarningsExact identifier
application number: M005
WISH HAND SANITIZER rose petalALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594befe7-1701-02a2-e063-6294a90a236c2026-08-18WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER SWEETR GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594c32b7-6905-4ab9-e063-6294a90a1db32026-08-18WarningsExact identifier
application number: M005
BYT BANGYTONG FOLLICULITIS5% BENZOYL PEROXIDE FOLLICULITISShenzhen Jindali Technology Co., Ltd595363f9-6aee-93a5-e063-6394a90a0f0e2026-08-18WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLEShield Line LLC9ddb13cd-34ed-2d63-e053-2a95a90ad9da2026-08-18WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f0c9f-645d-a047-e063-6294a90a996a2026-08-18WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESTOLNAFTATEYunqi Cosmetics (Shenzhen) Co., Ltd5939c492-6481-ddae-e063-6294a90a40bb2026-08-17WarningsExact identifier
application number: M005
WISH HAND SANITIZER cherry rougeALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593a7fc9-8d56-f9cb-e063-6294a90a3dae2026-08-17WarningsExact 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