FDA.reportPublic FDA data

Ringworm Treatment Cream

Product NDC
85398-024
11-digit product format
853980024
Labeler code
85398
Product ID
85398-024_55675f82-4b8a-44de-e063-6294a90a567e
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate 2%
Dosage form
CREAM
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-24
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
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
Ringworm Treatment Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998483Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4805462b-aec6-78fe-e063-6394a90ae066Available 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
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-024-01Ringworm Treatment Cream100 g in 1 CARTONCREAM1002
85398-024-01Hermon Ringworm Treatment Kit100 g in 1 CARTONCREAM1 g in 1002 g in 100g1

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 48 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERLIT CARE Hand SanitizerETHYL ALCOHOLEVERLIT GLOBAL INC.b9909c59-02e7-4d6c-aa2b-206f1ab4d02c2023-11-14WarningsExact identifier
application number: M005
FLUSH Maximum Strength Antifungal formulaUNDECYLENIC ACIDTriple Point Group, LLC1d9e56ef-c7c9-4aff-ab9e-b163e566e3d52023-11-11WarningsExact identifier
application number: M005
SIMPLY VITAL Antifungal CreamCLOTRIMAZOLEALPHA PLANTS INCd3842de3-0d13-4dc2-920b-90a4b822bbb82023-11-11WarningsExact identifier
application number: M005
CLARUS AC Antifungal SolutionTOLNAFTATEClinical Therapeutic Solutions28ab9f1b-65cd-4405-a9a3-f3c9b836693d2023-11-10WarningsExact identifier
application number: M005
Signature Black Bottle Tea Tree Antifungal Foot and Body WashTOLNAFTATERestoration Rockstar, Llc (dba: Kroning Signature Black Bottle)2c966d97-30f5-4942-b64d-742884ce6a2f2023-11-10WarningsExact identifier
application number: M005
Smooth Gator Fungus EliminatorCLOTRIMAZOLESmooth Gator, LLC262b04f5-1b5d-4c67-a557-01f8b17113022023-11-10WarningsExact identifier
application number: M005
TOLNAFTATE ANTIFUNGALTOLNAFTATEGeri-Care Pharmaceuticals, Corpf9e60430-eec1-4bc2-9522-eb5aa527d90a2023-11-08WarningsExact identifier
application number: M005
Terrasil Jock Itch Treatment Maximum StrengthCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCc62fbf23-5d19-44ab-9c1a-e9b803192ed02023-11-08WarningsExact identifier
application number: M005
terrasil The Fungal Solution KitCLOTRIMAZOLEAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions9a5eb581-62a2-41fe-a174-e852fc47e2352023-11-08WarningsExact identifier
application number: M005
EmoniNail AntifungalUNDECYLENIC ACIDGG Healthworks Inc.84ace47a-d3ae-4735-87b6-dbbf1c40cf542023-11-06WarningsExact identifier
application number: M005
CIDACIN Antifungal TreatmentTOLNAFTATEPedicis Research LLCbd53a9e3-65c8-4834-8e23-a2a928b83a662023-11-05WarningsExact identifier
application number: M005
MacerRx WebMICONAZOLE NITRATEClinical Therapeutic Solutionsc9327f41-10f1-41f3-855b-838c701d67672023-11-05WarningsExact identifier
application number: M005
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions7e8897ff-67d1-4336-866e-cb76a36edddc2023-11-05WarningsExact identifier
application number: M005
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions308a91d1-3511-4e2d-a62f-a31d77d70e062023-11-05WarningsExact identifier
application number: M005
Human Science Antifungal Foot CareUNDECYLENIC ACIDHUMAN SCIENCE, LLC26b2519b-7d7b-4b33-b5d6-a41fe6f735382023-11-05WarningsExact identifier
application number: M005
HomeHealth AntifungalTOLNAFTATEHome Health895cd24c-3f78-4e2e-bf98-8bb6605798da2023-11-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEProficient Rx LP800a9dab-d287-427e-af6d-26996e0def412023-11-01WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE-IODINEDr Radows58e1757c-45ce-455e-bd64-a9e99cd3680f2023-10-30WarningsExact identifier
application number: M005
JOCK-EZECLOTRIMAZOLEBentlin Products LLCd3ff5bfb-2e0f-4daa-84b3-4a3016ca92802023-10-30WarningsExact identifier
application number: M005
TheraPlus PlusCLOTRIMAZOLEZhejiang Jingwei Pharmaceutical Co., Ltd.de75179d-1889-4823-9f39-4bebdf185d762023-10-27WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN4805462b-aec6-78fe-e063-6394a90ae0662
998483miconazole nitrate 20 MG/ML Topical CreamSCD4805462b-aec6-78fe-e063-6394a90ae0662
998483miconazole nitrate 2 % Topical CreamSY4805462b-aec6-78fe-e063-6394a90ae0662
251267clotrimazole 1 % Medicated Bar SoapPSN4a9d9c6e-0e0f-d539-e063-6294a90acb571
998483miconazole nitrate 2 % Topical CreamPSN4a9d9c6e-0e0f-d539-e063-6294a90acb571
251267clotrimazole 0.01 MG/MG Medicated Bar SoapSCD4a9d9c6e-0e0f-d539-e063-6294a90acb571
998483miconazole nitrate 20 MG/ML Topical CreamSCD4a9d9c6e-0e0f-d539-e063-6294a90acb571
251267clotrimazole 1 % Medicated Bar SoapSY4a9d9c6e-0e0f-d539-e063-6294a90acb571
998483miconazole nitrate 2 % Topical CreamSY4a9d9c6e-0e0f-d539-e063-6294a90acb571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85398-024-0185398002401100 g in 1 CARTON (85398-024-01) 100 g2026-01-24NoNoCurrent