FDA.reportPublic FDA data

TriTolnacide C

Product NDC
73352-561
11-digit product format
733520561
Labeler code
73352
Product ID
73352-561_93f89016-a625-43cc-9537-6b2411e5ef7e
Type
HUMAN OTC DRUG
Nonproprietary name
tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifluent Pharma LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-17
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
TriTolnacide C
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103951Internal RxNorm lookup
2685262Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
12b53c2a-b073-43db-88d9-ede8300626aaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73352-561-10TriTolnacide C37 mL in 1 BOTTLE, WITH APPLICATORCREAM374
73352-561-10TriTolnacide C1 in 1 POUCHCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-561-10ML - Milliliter73352-561b028f486-18bb-4901-8e33-76f36053d16b12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73352-561TRITOLNACIDE C (TOLNAFTATE) CREAM [TRIFLUENT PHARMA LLC]3Current NDC, 2 package rows20241122_12b53c2a-b073-43db-88d9-ede8300626aa.zip

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 43 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleDRS. CLOTRIMAZOLEOL PHARMA TECH,LLCb0e9fc77-6d5c-2472-e053-2995a90a3de42025-01-09WarningsExact identifier
application number: M005
Anti-Bacterial WipesBENZALKONIUM CHLORIDETongling Jieya Biological Technology Co., Ltd.d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d2025-01-04WarningsExact identifier
application number: M005
AVON HeXashield Athletes Foot CreamTOLNAFTATETai Guk Pharm. Co., Ltd.8f2b6a09-8cb0-0d17-e053-2995a90aa07f2025-01-01WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATE 1%Trifecta Pharmaceuticals USA, LLC091b907f-544a-86c9-e063-6294a90a5d872024-12-31WarningsExact identifier
application number: M005
terrasil Fungal TreatmentCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions278290f9-be14-81a8-e063-6294a90ad8cc2024-12-26WarningsExact identifier
application number: M005
DEO PEDICO ABOVE NEYMAR JR MENDEO PEDICO ABOVE NEYMAR JR MENBASTON INDUSTRIA DE AEROSSOIS LTDAed4a9844-f20b-da5d-e053-2995a90adc092024-12-26WarningsExact identifier
application number: M005
Vite20MICONAZOLE NITRATEBlaine Labs Inc.28a8d0dd-aab9-44ff-bab6-7ec4b5036a712024-12-24WarningsExact identifier
application number: M005
Vite20UNDECYLENIC ACIDBlaine Labs Inc.18f8ea1c-360e-43c0-98df-5816af4dec662024-12-24WarningsExact identifier
application number: M005
Tolnaftate Cream 1% ANTIFUNGALFAMILY WELLNESS TOLNAFTATETrifecta Pharmaceuticals USA, LLC915759af-0d7f-6a87-e053-2a95a90acbd62024-12-20WarningsExact identifier
application number: M005
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLERugby Laboratoriesa1365bc7-b376-adca-e053-2a95a90acf192024-12-20WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL MICONAZOLE POWDER SPRAYPremier Brands of America Inc.dc7a23bb-b246-89b1-e053-2995a90a9f2d2024-12-20WarningsExact identifier
application number: M005
Warrior Antifungal FootMICONAZOLE NITRATE 2%Derma Care Research Labs, LLCcf2e9dc1-275b-4454-e053-2995a90af2952024-12-20WarningsExact identifier
application number: M005
Tolnaftate Cream 1%TOLNAFTATEPharmacy Value Alliance, LLC.3abfd734-229b-1a0e-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M005
Dermatool Fungal Nail TreatmentTOLNAFTATE 1%Derma Care Research Labs, LLCfbc1a55e-b994-4962-e053-6394a90a13ba2024-12-19WarningsExact identifier
application number: M005
Novonail SolutionTOLNAFTATE 1%Derma Care Research Labs, LLC013d6107-e3b0-0264-e063-6394a90ae1e22024-12-19WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATERugbyf420de00-408f-9a2c-e053-2995a90adced2024-12-17WarningsExact identifier
application number: M005
Relispray Antifungal LiquidTOLNAFTATEMidas-Care Pharmaceuticals Pvt. Ltd.6522ad59-f810-408c-a9f9-9359d79302ce2024-12-17WarningsExact identifier
application number: M005
ClotrimazoleFAMILY WELLNESS CLOTRIMAZOLETrifecta Pharmaceuticals USA LLC915759af-0d7b-6a87-e053-2a95a90acbd62024-12-13WarningsExact identifier
application number: M005
Blistex Odor-Eaters PowderTOLNAFTATEBlistex Inc819edb2f-dda7-45c3-b0da-ebcae354154e2024-12-12WarningsExact identifier
application number: M005
Walgreens Athletes FootTOLNAFTATE SPRAYWalgreensc68ad65d-b016-0069-e053-2995a90ae7ef2024-12-11WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSN12b53c2a-b073-43db-88d9-ede8300626aa4
2685262TriTolnacide C 1 % Topical CreamPSN12b53c2a-b073-43db-88d9-ede8300626aa4
2685262tolnaftate 10 MG/ML Topical Cream [Tritolnacide]SBD12b53c2a-b073-43db-88d9-ede8300626aa4
103951tolnaftate 10 MG/ML Topical CreamSCD12b53c2a-b073-43db-88d9-ede8300626aa4
103951tolnaftate 1 % Topical CreamSY12b53c2a-b073-43db-88d9-ede8300626aa4
2685262Tritolnacide 1 % Topical CreamSY12b53c2a-b073-43db-88d9-ede8300626aa4
2685262Tritolnacide 10 MG/ML Topical CreamSY12b53c2a-b073-43db-88d9-ede8300626aa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73352-561-10733520561101 BOTTLE, WITH APPLICATOR in 1 POUCH (73352-561-10) / 37 mL in 1 BOTTLE, WITH APPLICATOR2024-06-17NoNoCurrent