FDA.reportPublic FDA data

Pharmlitalia Antifungal Medicated Body

Product NDC
84938-010
11-digit product format
849380010
Labeler code
84938
Product ID
84938-010_4341084c-b074-897d-e063-6294a90a01a6
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Foshan Sugar Max Cosmetics CO.,Ltd
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-30
Substance
TOLNAFTATE
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Pharmlitalia Antifungal Medicated Body
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2383335Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
399302d2-0da4-4167-8884-b34a9aba8686Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84938-010-01Pharmlitalia Antifungal Medicated Body3.5 mL in 1 PATCHCLOTH3.52
84938-010-01Pharmlitalia Antifungal Medicated Body40 in 1 BOTTLECLOTH402

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 26 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bee Venom Toenail Fungus TreatmentBEE VENOM TOENAIL FUNGUS TREATMENTShenzhen Earth Surface Trading Co., Ltd.457c705a-9c49-c8c5-e063-6394a90a6aa32025-12-08WarningsExact identifier
application number: M005
Tolnaftate Antifungal PowderTOLNAFTATESCHOLL'S WELLNESS COMPANY LLC2a0e006b-60b1-41b9-a5d2-ff0e34b48ff52025-12-06WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions1e7e74f6-9bca-48ab-804a-a7a81df3b6082025-12-05WarningsExact identifier
application number: M005
Oiangna Tea Tree Oil AntifungalCLOTRIMAZOLE 1%Guangzhou Huixue Biotechnology Co., Ltd.453452a7-c613-6111-e063-6294a90aca812025-12-05WarningsExact identifier
application number: M005
Tinactin AntifungalTOLNAFTATEBayer HealthCare LLC.5f95be36-6efa-4dfb-9a40-88f4ce1de2b32025-12-05WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLC.c3b715a9-233a-401a-ba60-f78c1ddf1ded2025-12-05WarningsExact identifier
application number: M005
LotriminCLOTRIMAZOLEBayer HealthCare LLC.b584e17f-ed43-43bd-b643-dfa48edd78c62025-12-05WarningsExact identifier
application number: M005
Fungicure Night CreamCLOTRIMAZOLEKobayashi Healthcare International, Inc.43029403-2afd-cfa1-e063-6394a90a99a32025-12-04WarningsExact identifier
application number: M005
Lotrimin Daily Prevention DeoTOLNAFTATEBayer HealthCare LLC.9e8bfb78-ad81-93d0-e053-2995a90aa41d2025-12-04WarningsExact identifier
application number: M005
Lotrimin AF Jock ItchMICONAZOLE NITRATEBayer Healthcare LLC.0c53cf0f-767e-a422-e063-6394a90ab7642025-12-04WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLC.0a80a5b0-3216-46f6-8801-7066ef59aee42025-12-04WarningsExact identifier
application number: M005
Lotrimin AntifungalCLOTRIMAZOLEBayer HealthCare LLC.f9536683-3f32-4c71-9b6a-70f8611e3dcf2025-12-04WarningsExact identifier
application number: M005
Lotrimin AF DeodorantMICONAZOLE NITRATEBayer HealthCare LLC.0bee54eb-df2f-15fe-e063-6294a90a2fd22025-12-04WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLC.0beda157-efd2-5245-e063-6394a90a69112025-12-04WarningsExact identifier
application number: M005
Lotrimin AFMICONAZOLE NITRATEBayer Healthcare LLC.163996c6-af54-21ac-e063-6394a90ac05c2025-12-04WarningsExact identifier
application number: M005
Lotrimin Daily Prevent DeodorantTOLNAFTATEBayer HealthCare LLC.1bb961cd-b6e6-3aff-e063-6394a90a432e2025-12-04WarningsExact identifier
application number: M005
Tinactin DeodorantTOLNAFTATEBayer HealthCare LLC.1751d576-e94a-d7d1-e063-6294a90a03ff2025-12-04WarningsExact identifier
application number: M005
Tinactin Jock ItchTOLNAFTATEBayer HealthCare LLC163ab4df-6e4a-6239-e063-6294a90a1cd02025-12-04WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLCbb878f31-2189-4427-aacf-5bce96d759782025-12-04WarningsExact identifier
application number: M005
LotriminCLOTRIMAZOLEBayer HealthCare LLCda948ef3-3709-4bfc-9d17-f6f1ea3253432025-12-04WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2383335tolnaftate 1 % Medicated PadPSN399302d2-0da4-4167-8884-b34a9aba86862
2383335tolnaftate 10 MG/ML Medicated PadSCD399302d2-0da4-4167-8884-b34a9aba86862
2383335tolnaftate 1 % Medicated PadSY399302d2-0da4-4167-8884-b34a9aba86862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84938-010-018493800100140 PATCH in 1 BOTTLE (84938-010-01) / 3.5 mL in 1 PATCH40 patch2025-10-30NoNoCurrent