FDA.reportPublic FDA data

dandRX 1% Ketoconazole Anti-Dandruff

Product NDC
85521-001
11-digit product format
855210001
Labeler code
85521
Product ID
85521-001_324fb7bb-4b8f-e6e6-e063-6394a90adae1
Type
HUMAN OTC DRUG
Nonproprietary name
dandRX 1% Ketoconazole Anti-Dandruff Shampoo
Dosage form
LIQUID
Route
TOPICAL
Labeler
dandRX LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-09
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
dandRX 1% Ketoconazole Anti-Dandruff
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR9400W927I
Rxcui240812

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]1Current NDC, 1 package rows20250410_324fb7bb-4b8e-e6e6-e063-6394a90adae1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240812ketoconazole 1 % Medicated ShampooPSN324fb7bb-4b8e-e6e6-e063-6394a90adae11
240812ketoconazole 10 MG/ML Medicated ShampooSCD324fb7bb-4b8e-e6e6-e063-6394a90adae11
240812ketoconazole 1 % Medicated ShampooSY324fb7bb-4b8e-e6e6-e063-6394a90adae11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85521-001-0185521000101236 mL in 1 BOTTLE (85521-001-01) 236 ml2025-04-09NoNoHistorical