FDA.reportPublic FDA data

dandRX 1% Ketoconazole Anti-Dandruff

Manufacturer
dandRX LLC
Effective date
2025-04-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:53

Label at a glance#

ProductdandRX 1% Ketoconazole Anti-Dandruff
Active ingredientKETOCONAZOLE
Label structure12 sections

Dosage and administration

Directions: for best results, use every other day or as directed by a doctor. ■ Wet hair thoroughly ■ Massage a liberal amount into your scalp. ■ Leave lather on scalp for several minutes ■ Rinse and repeat

Storage and handling

Other information: store at room temperature between 68-78°F(20-25°C). Do not expose to excessive heat.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

KETOCONAZOLE 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Use

INDICATIONS & USAGE SECTION

Use: for the control of the symptoms of dandruff and or seborrheic dermatitis.

Warnings

WARNINGS SECTION

for external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use on open skin wounds

OTC - WHEN USING SECTION

When using this product avoid contact witheyes,if contact occurs. rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: for best results, use every other day or as directed by a doctor.

■ Wet hair thoroughly
■ Massage a liberal amount into your scalp.
■ Leave lather on scalp for several minutes
■ Rinse and repeat

Other information

STORAGE AND HANDLING SECTION

Other information: store at room
temperature between 68-78°F(20-25°C).
Do not expose to excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Aloe Vera Leaf, Sodium Cocoyl Isethion-ate, Sodium LauroyI Methyl Isethionate, Co-
camidopropyl Hydroxysultaine, Oatmeal, Pan-thenol, Chamomile, Green Tea Leaf, Calendula
Officinalis Flower, Glycerin, Squalane, Cocos Nucifera (Coconut) Oil, Melaleuca Alternifolia
(Tea Tree) Leaf Oil, Azadirachta Indica Flower, Leuconostoc/Radish Root Ferment Filtrate, So-
dium Benzoate, Citric Acid

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240812ketoconazole 1 % Medicated ShampooPSN1
240812ketoconazole 10 MG/ML Medicated ShampooSCD1
240812ketoconazole 1 % Medicated ShampooSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

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
85521-001-01dandRX 1% Ketoconazole Anti-Dandruff236 mL in 1 BOTTLELIQUID2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85521-001DANDRX 1% KETOCONAZOLE ANTI-DANDRUFF (DANDRX 1% KETOCONAZOLE ANTI-DANDRUFF SHAMPOO) LIQUID [DANDRX LLC]11 package rows20250410_324fb7bb-4b8e-e6e6-e063-6394a90adae1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85521-00185521-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
AQUA059QF0KO0RIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
SODIUM LAUROYL METHYL ISETHIONATEII6VCD3S6RIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
OATMEAL8PI54V663YIACT
PANTHENOLWV9CM0O67ZIACT
CHAMOMILEFGL3685T2XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
KETOCONAZOLER9400W927IACTIB
SODIUM BENZOATEOJ245FE5EUIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
AZADIRACHTA INDICA FLOWER3TE8A92UPMIACT
SQUALANEGW89575KF9IACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID2968PHW8QPIACT

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
56952802-ac83-fe46-e063-6394a90a5695324fb7bb-4b8e-e6e6-e063-6394a90adae12026-07-14WarningsExact identifier
spl set id: 324fb7bb-4b8e-e6e6-e063-6394a90adae1

Reported adverse events (FAERS/openFDA)#

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