RoyceDerm Antifungal Bar

Product NDC
85424-005
11-digit product format
854240005
Labeler code
85424
Product ID
85424-005_4e5e3a3a-ab41-10ca-e063-6294a90ace0e
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
SOAP
Route
TOPICAL
Labeler
RoyceDerm LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-08
Substance
CLOTRIMAZOLE
Active strength
2.32 g/232g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RoyceDerm Antifungal Bar
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE2.32 g/232g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui251267

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-005-01RoyceDerm Antifungal Bar232 g in 1 CARTONSOAP2322
85424-005-02RoyceDerm Antifungal Bar226 g in 1 CARTONSOAP2262

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251267clotrimazole 1 % Medicated Bar SoapPSN3abdc4a8-58dd-5bd0-e063-6294a90a1bca2
251267clotrimazole 0.01 MG/MG Medicated Bar SoapSCD3abdc4a8-58dd-5bd0-e063-6294a90a1bca2
251267clotrimazole 1 % Medicated Bar SoapSY3abdc4a8-58dd-5bd0-e063-6294a90a1bca2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-005-0185424000501232 g in 1 CARTON (85424-005-01) 232 g2025-08-08NoNoHistorical
85424-005-0285424000502226 g in 1 CARTON (85424-005-02) 226 g2026-04-20NoNoHistorical