FDA.reportPublic FDA data

Fungi Nail Toe and Foot

Product NDC
55505-177
11-digit product format
555050177
Labeler code
55505
Product ID
55505-177_29be9a78-384b-4807-ab8b-1417d6e0e48f
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Kramer Laboratories
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-25
Substance
TOLNAFTATE
Active strength
10 mg/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
Fungi Nail Toe and Foot
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/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
2120579Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3ae043b-dc97-449b-b099-70bdf8e92482Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-177-24Fungi Nail Toe and Foot1 in 1 CARTONSOLUTION17
55505-177-24Fungi Nail Toe and Foot15 mL in 1 BOTTLE, WITH APPLICATORSOLUTION157
55505-177-26Fungi Nail Toe and Foot1 in 1 CARTONSOLUTION17
55505-177-26Fungi Nail Toe and Foot30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION307
55505-177-80Fungi Nail Toe and Foot1 in 1 CARTONSOLUTION17
55505-177-80Fungi Nail Toe and Foot30 mL in 1 BOTTLE, SPRAYSOLUTION307
55505-177-87Fungi Nail Toe and Foot2 in 1 PACKAGESOLUTION27
55505-177-87Fungi Nail Toe and Foot1 in 1 CARTONSOLUTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55505-177FUNGI NAIL TOE AND FOOT (TOLNAFTATE) SOLUTION [KRAMER LABORATORIES]6Current NDC, Legacy NDC, 8 package rows20250323_a3ae043b-dc97-449b-b099-70bdf8e92482.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 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Dr. Rainer s Vaginal CreamMICONAZOLE NITRATEPlexoris Health Care Products, Llc1f0ee635-c70d-4194-a01d-370ca5c22fcd2024-12-11WarningsExact identifier
application number: M005
BOA VIDA AntifungalMICONAZOLE NITRATECentral Solutions Inc69c5340d-9abd-43bf-a90b-9568d615f06f2024-12-09WarningsExact identifier
application number: M005
BLUESEA DISPOSABLE HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTD7a552be2-a9e1-4c6f-b1c2-79113a73bd2f2024-12-06WarningsExact identifier
application number: M005
U HAND SANITIZER CLASSICBENZALKONIUM CHLORIDEBLUE SEA AEROSOL & DAILY CARE CO., LTDfbc27a24-0e81-4907-b24f-881c4fe0ec442024-12-06WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2120579FUNGI-NAIL 1 % Topical Solution, Reformulated Mar 2019PSNa3ae043b-dc97-449b-b099-70bdf8e924827
313423tolnaftate 1 % Topical SolutionPSNa3ae043b-dc97-449b-b099-70bdf8e924827
2120579tolnaftate 10 MG/ML Topical Solution [Fungi-Nail Reformulated Mar 2019]SBDa3ae043b-dc97-449b-b099-70bdf8e924827
313423tolnaftate 10 MG/ML Topical SolutionSCDa3ae043b-dc97-449b-b099-70bdf8e924827
2120579Fungi-Nail Reformulated Mar 2019 1 % Topical SolutionSYa3ae043b-dc97-449b-b099-70bdf8e924827
2120579Fungi-Nail Reformulated Mar 2019 10 MG/ML Topical SolutionSYa3ae043b-dc97-449b-b099-70bdf8e924827
313423tolnaftate 1 % Topical SolutionSYa3ae043b-dc97-449b-b099-70bdf8e924827

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55505-177-24555050177241 BOTTLE, WITH APPLICATOR in 1 CARTON (55505-177-24) / 15 mL in 1 BOTTLE, WITH APPLICATOR2025-04-01NoNoCurrent
55505-177-26555050177261 BOTTLE, WITH APPLICATOR in 1 CARTON (55505-177-26) / 30 mL in 1 BOTTLE, WITH APPLICATOR2019-03-250000-00-00NoNoCurrent
55505-177-80555050177801 BOTTLE, SPRAY in 1 CARTON (55505-177-80) / 30 mL in 1 BOTTLE, SPRAY2022-12-100000-00-00NoNoCurrent
55505-177-87555050177872 CARTON in 1 PACKAGE (55505-177-87) / 1 BOTTLE, WITH APPLICATOR in 1 CARTON / 30 mL in 1 BOTTLE, WITH APPLICATOR2 carton2019-12-27NoNoCurrent