RoyceDerm Tea Tree Oil Antifungal soap.

Product NDC
85424-004
11-digit product format
854240004
Labeler code
85424
Product ID
85424-004_4ab6a114-2227-d4de-e063-6294a90a9bf6
Type
HUMAN OTC DRUG
Nonproprietary name
Tea Tree Oil Antifungal soap
Dosage form
SOAP
Route
TOPICAL
Labeler
RoyceDerm LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-06
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 Tea Tree Oil Antifungal soap.
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
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-004-01RoyceDerm Tea Tree Oil Antifungal soap.232 g in 1 CARTONSOAP2324
85424-004-02RoyceDerm Tea Tree Oil Antifungal soap.232 g in 1 CARTONSOAP2324

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251267clotrimazole 1 % Medicated Bar SoapPSN3a6d1e32-a38b-3dde-e063-6394a90a88f34
251267clotrimazole 0.01 MG/MG Medicated Bar SoapSCD3a6d1e32-a38b-3dde-e063-6394a90a88f34
251267clotrimazole 1 % Medicated Bar SoapSY3a6d1e32-a38b-3dde-e063-6394a90a88f34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-004-0185424000401232 g in 1 CARTON232 gHistorical
85424-004-0285424000402232 g in 1 CARTON (85424-004-02) 232 g2026-01-01NoNoHistorical