RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar

Product NDC
85424-008
11-digit product format
854240008
Labeler code
85424
Product ID
85424-008_3b98a83d-9c3c-9522-e063-6294a90a7033
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc 2%
Dosage form
SOAP
Route
TOPICAL
Labeler
RoyceDerm LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-31
Substance
PYRITHIONE ZINC
Active strength
4.52 g/226g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC4.52 g/226g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR953O2RHZ5
Rxcui283707

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-008-01RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar226 g in 1 CARTONSOAP2261

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283707zinc pyrithione 2 % Medicated Bar SoapPSN3b98a83d-9c3b-9522-e063-6294a90a70331
283707zinc pyrithione 0.02 MG/MG Medicated Bar SoapSCD3b98a83d-9c3b-9522-e063-6294a90a70331
283707zinc pyrithione 2 % Medicated Bar SoapSY3b98a83d-9c3b-9522-e063-6294a90a70331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-008-0185424000801226 g in 1 CARTON (85424-008-01) 226 g2025-08-31NoNoHistorical