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 12 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Athletes FootMICONAZOLE NITRATEPremier Brands of America Inc52d0909a-f404-0af4-e063-6394a90a3d0c2026-06-01WarningsExact identifier
application number: M005
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd431483f6-2386-9f5c-e063-6294a90af1042026-06-01WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEWalgreens Company3f8d45e1-54a2-a658-e063-6294a90a6cbb2026-06-01WarningsExact identifier
application number: M005
Remedy NailsUNDECYLENIC ACIDAdwill Labs Inc4e87b76c-c430-466a-bc30-fe1785c7c6602026-06-01WarningsExact identifier
application number: M005
Anytalk Nail Fungus Treatment 15ml (1% Tonailate)TOLNAFTATE1%Guangzhou Huixue Biotechnology Co., Ltd.52f1f654-fba3-e90e-e063-6394a90a1df42026-05-29WarningsExact identifier
application number: M005
RoyceDerm Tea Tree Oil Antifungal .spray.CLOTRIMAZOLE 1%RoyceDerm LLC52da8be4-467c-c011-e063-6294a90a166f2026-05-28WarningsExact identifier
application number: M005
Terramed Just Think Comfort Jock Itch Antifungal TreatmentMICONAZOLE NITRATERida LLC2acb9027-8f20-4b77-9b45-17fe11622c7c2026-05-27WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL TEA TREETOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd52b3b0df-3f62-f9bc-e063-6394a90a52b32026-05-26WarningsExact identifier
application number: M005
ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b51877-e04c-569e-e063-6394a90a2fc92026-05-26WarningsExact identifier
application number: M005
NAIL EXTRA STRENGTH REPAIR PENUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6208d-53e4-eaa0-e063-6394a90abe7a2026-05-26WarningsExact identifier
application number: M005
Toenail Fungus Pen PreventativeUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6766f-948b-2602-e063-6294a90a03cf2026-05-26WarningsExact identifier
application number: M005
KDMANTOLNAFTATEDongguan Youmi Trading Co., Ltd52a4e836-2059-a49f-e063-6394a90a65562026-05-25WarningsExact identifier
application number: M005
PUTRIZENUNDECYLENIC ACID, TOLNAFTATEGuangzhou Lianbiquan Biological Technology co., Ltd52a58f24-2a11-4d34-e063-6394a90a29242026-05-25WarningsExact identifier
application number: M005
Eye CareSprayEYELID CLEANSING SPRAYShenzhen Shierjie Biological Engineering Co., LTD52aef5dd-ff33-cace-e063-6294a90a415a2026-05-25WarningsExact identifier
application number: M005
Saviland PRO Extra Strength Toenail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD5250003a-8d3a-818b-e063-6294a90aa6592026-05-21WarningsExact identifier
application number: M005
Saviland SSPro X Series Extra Strength Toenail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52506297-44d7-b2a7-e063-6394a90a0a3c2026-05-21WarningsExact identifier
application number: M005
SSPROTIP X Extra Strength Nail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52512e7e-5e28-4383-e063-6294a90a448a2026-05-21WarningsExact identifier
application number: M005
Vrenmol Extra Strength Nail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52516861-e386-d0cb-e063-6394a90a17d02026-05-21WarningsExact identifier
application number: M005
SSPROTIP X Extra Strength Toenail Renewal SolutionTOLNAFTATE,UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52519110-a3c9-21da-e063-6294a90abbce2026-05-21WarningsExact identifier
application number: M005
Fungal Nail Repair PenUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd523c32f7-b803-bf79-e063-6394a90aad5a2026-05-20WarningsExact 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