FDA.reportPublic FDA data

Athlete Foot Treatment Kit

Product NDC
85398-008
11-digit product format
853980008
Labeler code
85398
Product ID
85398-008_5566fc4d-92a2-8e17-e063-6394a90aabe6
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride, Tolnaftate
Dosage form
KIT
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-20
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
Athlete Foot Treatment Kit
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992528Internal RxNorm lookup
1807715Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b3aa69f-4e73-cabc-e063-6294a90ab65bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-006-01Athlete Foot Treatment Kit60 g in 1 CARTONCREAM60 g1 g in 100g2
85398-007-01Athlete Foot Treatment Kit232 g in 1 CARTONSOAP232 g1 g in 100g2
85398-008-01Athlete Foot Treatment Kit1 in 1 CARTONKIT12

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 13 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Clotrimazole 1% ANTIFUNGAL CreamCLOTRIMAZOLEUnifirst First Aid Corporation522eeb91-8378-32f4-e063-6394a90aff432026-05-20WarningsExact identifier
application number: M005
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd47cf1251-5965-045a-e063-6394a90ab04f2026-05-19WarningsExact identifier
application number: M005
APUREE PRO Nailtific Maximum Strength Antifungal PatchesAPUREE PRO NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHESGuangzhou Meixi Biotechnology Co., Ltd.5218bd5d-53b4-107f-e063-6394a90ae7692026-05-18Exact identifier
application number: M005
APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal PenAPUREE PRO NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PENGuangzhou Meixi Biotechnology Co., Ltd.521a0e40-a218-fabb-e063-6294a90ae9a22026-05-18WarningsExact identifier
application number: M005
Beukow Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENJiangxi Yudexi Pharmaceutical Co., LTD511d1edf-dfda-477c-e063-6294a90aa4232026-05-17WarningsExact identifier
application number: M005
Nail Repair PenNAIL REPAIR PENShenzhen Earth Surface Trading Co., Ltd.520f6514-6660-d6a8-e063-6394a90adf822026-05-17WarningsExact identifier
application number: M005
Fungicure IntensiveCLOTRIMAZOLEKobayashi Healthcare International, Inc.1f1b413f-278e-434f-8590-4cf731663f5c2026-05-15WarningsExact identifier
application number: M005
Dr Scholls Fungal Nail Clear and Cure Tolnaftate AntifungalTOLNAFTATEScholl's Wellness Company LLC8abd6d8e-c69e-4374-ace8-d42b2d3e171e2026-05-14WarningsExact identifier
application number: M005
Dr.Scholl s Odor X Athlete s FootTOLNAFTATEScholl's Wellness Company LLC0e864882-5e00-491e-a008-0762c131637a2026-05-14WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATERugby Laboratories50c46cf5-3e64-9e0f-e063-6294a90a23172026-05-14WarningsExact identifier
application number: M005
TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse WipesTOSSOYA RAINFOREST SECRETGUARD ANTIBACTERIAL QUICK-CLEANSE WIPESShenzhen Shierjie Biological Engineering Co., LTD3d53463d-8d8e-9030-e063-6294a90ab4542026-05-13WarningsExact identifier
application number: M005
Anti-Fungal PowderMICONAZOLE NITRATECVS Pharmacy1651bdd7-ab15-7a2d-e063-6294a90a8b912026-05-11WarningsExact identifier
application number: M005
Lightning X Hand CleanserETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.51861f1e-8961-e876-e063-6394a90a2fd02026-05-11WarningsExact identifier
application number: M005
APUREE Nailtific Maximum Strength Antifungal Patches PROAPUREE NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES PROGuangzhou Meixi Biotechnology Co., Ltd5189ebc5-8ee5-1b2c-e063-6294a90af5c82026-05-11WarningsExact identifier
application number: M005
APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen ProAPUREE NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN PROGuangzhou Meixi Biotechnology Co., Ltd.518abf2b-6ac8-ab9b-e063-6294a90ae6932026-05-11WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories, Inc.2c60e631-5930-4420-886d-eb1990c720b62026-05-11WarningsExact identifier
application number: M005
TolfyraTOLNAFTATEOncora Pharma, LLCb28ee9f2-fc45-4336-b374-be7aa51d44e92026-05-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsc0f58a0d-a304-41f9-bbdf-c2e488230cf02026-05-11WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd5148b838-d26e-cf66-e063-6394a90ae4692026-05-09WarningsExact identifier
application number: M005
HuiPoLii NAIL PFLASTERTOLNAFTATE 1% NAIL PFLASTERJiangxi Yudexi Pharmaceutical Co., LTD514b1c2d-cecb-30a2-e063-6394a90af2662026-05-08WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSN3b3aa69f-4e73-cabc-e063-6294a90ab65b2
1807715tolnaftate 1 % Medicated Bar SoapPSN3b3aa69f-4e73-cabc-e063-6294a90ab65b2
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD3b3aa69f-4e73-cabc-e063-6294a90ab65b2
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD3b3aa69f-4e73-cabc-e063-6294a90ab65b2
992528terbinafine hydrochloride 1 % Topical CreamSY3b3aa69f-4e73-cabc-e063-6294a90ab65b2
1807715tolnaftate 1 % Medicated Bar SoapSY3b3aa69f-4e73-cabc-e063-6294a90ab65b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85398-006-018539800060160 g in 1 CARTON60 gHistorical
85398-007-0185398000701232 g in 1 CARTON232 gHistorical
85398-008-01853980008011 KIT in 1 CARTON (85398-008-01) * 60 g in 1 CARTON (85398-006-01) * 232 g in 1 CARTON (85398-007-01) 1 kit2025-08-20NoNoCurrent