FDA.reportPublic FDA data

Tritolnacide S

Product NDC
73352-560
11-digit product format
733520560
Labeler code
73352
Product ID
73352-560_c2f1ce6f-ae52-4a32-9e7c-e7ca6d802240
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Trifluent Pharma LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-11
Substance
TOLNAFTATE
Active strength
.01 g/mL
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 S
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE.01 g/mL

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
313423Internal RxNorm lookup
2679333Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b69ba7c9-03c1-4f5e-aa93-3ea1f2db15d8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73352-560-01Tritolnacide S15 mL in 1 BOTTLE, WITH APPLICATORSOLUTION154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-560-01ML - Milliliter73352-560f3bf87b2-0ada-43ea-8555-2e8e58f9471812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73352-560TRITOLNACIDE S (TOLNAFTATE) SOLUTION [TRIFLUENT PHARMA LLC]3Current NDC, 1 package rows20241122_b69ba7c9-03c1-4f5e-aa93-3ea1f2db15d8.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 49 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Evercare Antifungal Treatment Super Absorbent PowderMICONAZOLE NITRATEPANEFFORT, LLCf91910f3-b461-43a4-9120-fda69483fffa2023-10-26WarningsExact identifier
application number: M005
Thera plus Antifungal ClotrimazoleCLOTRIMAZOLEFOURSTAR GROUP USA, INC.1265be99-8922-4b76-bd63-19bfb42c38962023-10-26WarningsExact identifier
application number: M005
Thera plus Antifungal TolnaftateTOLNAFTATEFOURSTAR GROUP USA, INC.c628dda8-7a6d-5f3a-e053-2995a90a35f82023-10-26WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltde1789944-3a41-4c86-b173-3a6993ae21412023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltd14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltdb82cea56-b09f-411d-a6cf-c53b3ce0e3b62023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd78131b57-1ffc-4eb8-821e-f7bb73300fe92023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltdeb30e5de-9074-4760-8e92-e1d1c127227d2023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltd0bd3de76-b726-41f1-87bc-14ab8a1eca8e2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltdbe85ec5b-eb49-4f1a-a87d-5c9705a20f232023-10-22WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.579c1ab5-50b4-4b5a-a189-c1e2827d0c3a2023-10-14WarningsExact identifier
application number: M005
Micomitin AntifungalCLOTRIMAZOLEPureTek Corporationdd05f5f9-2412-1295-e053-2995a90acb962022-02-14WarningsExact identifier
application number: M005
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313423tolnaftate 1 % Topical SolutionPSNb69ba7c9-03c1-4f5e-aa93-3ea1f2db15d84
2679333TriTolnacide S 1 % Topical SolutionPSNb69ba7c9-03c1-4f5e-aa93-3ea1f2db15d84
2679333tolnaftate 10 MG/ML Topical Solution [Tritolnacide]SBDb69ba7c9-03c1-4f5e-aa93-3ea1f2db15d84
313423tolnaftate 10 MG/ML Topical SolutionSCDb69ba7c9-03c1-4f5e-aa93-3ea1f2db15d84
313423tolnaftate 1 % Topical SolutionSYb69ba7c9-03c1-4f5e-aa93-3ea1f2db15d84
2679333Tritolnacide 1 % Topical SolutionSYb69ba7c9-03c1-4f5e-aa93-3ea1f2db15d84
2679333Tritolnacide 10 MG/ML Topical SolutionSYb69ba7c9-03c1-4f5e-aa93-3ea1f2db15d84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73352-560-017335205600115 mL in 1 BOTTLE, WITH APPLICATOR (73352-560-01) 15 ml2023-12-11NoNoCurrent