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 47 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aidee198aa1-ad0d-9185-e053-2a95a90a65952024-01-15WarningsExact identifier
application number: M005
Ever Ready HAND SANITIZERETHYL ALCOHOLEver Ready First Aidec1af7ef-3c95-9c60-e053-2a95a90acf472024-01-15WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERETHYL ALCOHOLSled Distribution, LLCe7451738-75d5-5dc4-e053-2a95a90a7aee2024-01-15WarningsExact identifier
application number: M005
Medical SuperALCOHOLBeijing HKKY Medical Tech. Co., Ltd.ed2649c6-d971-4338-8745-cd0a40f7b0c22024-01-13WarningsExact identifier
application number: M005
ER Hand Sanitizer PacketsALCOHOLEVER READY FIRST AIDd0b6d09c-26e0-45c7-8d37-7d42143b2e312024-01-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEProficient Rx LPeeb241a3-93ee-4b74-8cbb-65713d15e7e02024-01-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEProficient Rx LPba1dc4a4-073f-4f30-bb9c-9ed0437004312024-01-01WarningsExact identifier
application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEProficient Rx LP7c64553b-589c-4e65-a6f0-b2847bbbe8a62024-01-01WarningsExact identifier
application number: M005
Dr. Scholls Instant Cool Athletes foot treatment with MentholTOLNAFTATEScholl's Wellness Companydad00745-e411-35b8-e053-2a95a90a10002023-12-21WarningsExact identifier
application number: M005
TINEACIDETOLNAFTATEBlaine Labs Inc.273eb424-5dc3-40c8-9ea7-2f732cbd11c92023-12-21WarningsExact identifier
application number: M005
TERPENICOL ANTIFUNGALUNDECYLENIC ACIDBlaine Labs Inc.a020334e-aac9-4ea5-a0ea-8e5b021fe2eb2023-12-21WarningsExact identifier
application number: M005
TERPENICOLUNDECYLENIC ACIDBlaine Labs Inc.efd99ed1-07d3-4862-ae47-883f7d1c91c62023-12-21WarningsExact identifier
application number: M005
sunmark antifungalTOLNAFTATEA-S Medication Solutions6f85fbb0-297c-4949-83f2-ed9a521721542023-12-16WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7a0ef38a-9584-4e67-ba86-c31f86da1ed02023-12-11WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7d284f6f-a970-49fe-b45a-d5c6c2688bc22023-12-11WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.2096e241-3ed3-49cd-88c4-71db1fd2934a2023-12-06WarningsExact identifier
application number: M005
Undecylenic AcidUNDECYLENIC ACIDChemco Corporation7391b53f-5567-1f45-e053-2991aa0a4fce2023-12-05WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.be92b480-56e8-4371-adbc-40fe74f6747c2023-12-01WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb4c4240f-f84c-ec5e-e053-2a95a90aa0822023-11-17WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb564f971-2a9b-a605-e053-2995a90aee692023-11-17WarningsExact 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