FDA.reportPublic FDA data

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

Reported adverse events (FAERS/openFDA)#

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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251267Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3abdc4a8-58dd-5bd0-e063-6294a90a1bcaAvailable on FDA.report

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

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 20 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARMBANNER TINEA VERSICOLOR CreamTINEA VERSICOLOR CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3db832f4-630d-72a2-e063-6394a90a08dc2026-02-12WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREEChain Drug Consortium, LLC5f9edcf9-b99e-65a2-e053-2a91aa0af5652026-02-12WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYChain Drug Consortium, LLC5fafc16d-7257-fc88-e053-2991aa0a67c42026-02-12WarningsExact identifier
application number: M005
Kerova Miconazole NitrateMICONAZOLE NITRATEGuangzhou Bixiaoyu Trading Co., Ltd.3b8b5547-f8d1-9e48-e063-6294a90af4292026-02-12WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLCa980ff33-2b6d-3065-e053-2995a90ae9742026-02-11WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4a8265c5-9c69-a36a-e063-6294a90ab2922026-02-11WarningsExact identifier
application number: M005
Tuymec FUNGAL NAIL TREATMENT KitFUNGAL NAIL TREATMENT KITGuangzhou Jingliang Cosmetics Co., Ltd.4a983b42-9723-7a3a-e063-6394a90ae7b22026-02-11WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT SPRAYCVS Pharmacy1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c2026-02-10WarningsExact identifier
application number: M005
Kerova ANTIFUNGALCLOTRIMAZOLEGuangzhou Bixiaoyu Trading Co., Ltd.4a7b48cf-72c3-be63-e063-6394a90a1efe2026-02-10WarningsExact identifier
application number: M005
Kerova ClotrimazoleANTIFUNGALGuangzhou Bixiaoyu Trading Co., Ltd.4a7b9658-f411-299d-e063-6394a90af9ce2026-02-10WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLC3b1209fc-9d6b-2f55-e063-6394a90ac2ad2026-02-10WarningsExact identifier
application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete FeetNABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEETNabrace LLC0fdd1658-5759-8a42-e063-6394a90a72712026-02-10WarningsExact identifier
application number: M005
APUREE Nailtific Extra-Max Strength AntigungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH ANTIGUNGALGuangzhou Meixi Biotechnology Co., Ltd.4a633da8-dcba-349c-e063-6294a90a77022026-02-09WarningsExact identifier
application number: M005
Fungus Master Antifungal TreatmentMICONAZOLE NITRATEEbanel Laboratories, Incf7b011b2-11e5-46f1-afed-89f438985e002026-02-09WarningsExact identifier
application number: M005
OSIMOON Toenail Fungus TreatmentTOENAIL FUNGUS TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.4a7061a9-8ba2-72b8-e063-6294a90a4d9a2026-02-09WarningsExact identifier
application number: M005
CLOTRIMAZOLE 1%CLOTRIMAZOLEPHARMACY CHOICE INC43852cfb-6d28-e54f-e063-6394a90aa0902026-02-08WarningsExact identifier
application number: M005
ASSIELF ANTIFUNGAL PENUNDECYLENIC ACIDShenzhen Yuanbang International Logistics Co., Ltd4a5d8e86-6401-7556-e063-6394a90acce12026-02-08WarningsExact identifier
application number: M005
Dryello Dual Action Relief for Athlete FootTOLNAFTATEProPedix, Inc.359478dd-02c9-05e5-e063-6294a90a41ed2026-02-06WarningsExact identifier
application number: M005
HEALMUSZ ClotrimazoleCLOTRIMAZOLE1% MICONAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD4a326159-a6a7-c1d6-e063-6294a90a3b892026-02-06WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEWal-Mart Stores, Inc.17d0486e-e8b5-3afe-e063-6394a90aa3842026-02-04WarningsExact identifier
application number: M005

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 g2025-08-08NoNoCurrent
85424-005-0285424000502226 g in 1 CARTON (85424-005-02) 226 g2026-04-20NoNoCurrent