FDA.reportPublic FDA data

Tolfyra

Product NDC
85477-331
11-digit product format
854770331
Labeler code
85477
Product ID
85477-331_9a2daff0-df69-4dd4-9b2b-84d1b74de374
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
LIQUID
Route
TOPICAL
Labeler
Oncora Pharma, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-01
Substance
TOLNAFTATE
Active strength
.3 g/30mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Tolfyra
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE.3 g/30mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313423Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b28ee9f2-fc45-4336-b374-be7aa51d44e9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85477-331-01Tolfyra30 mL in 1 BOTTLE, WITH APPLICATORLIQUID306

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 31 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Antifungal LiquidTOLNAFTATEFSA Store Inc.fae36294-68b6-bf14-e053-6394a90aaacd2025-10-27WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.58dd955e-e68b-4fbd-90c8-a85b15c00dc72025-10-25WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLEVERLIT GLOBAL INC.1360cdd8-b2b2-4af9-b6ff-af1101d49e182025-10-25WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYBetter Living Brands LLCccff8d63-ee7d-eada-e053-2995a90ac5dd2025-10-24WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYBetter Living Brands LLCccff4830-6d81-2a0d-e053-2a95a90a154c2025-10-24WarningsExact identifier
application number: M005
Liquid Antifungal TreatmentTOLNAFTATEHudson Health LLC14a9efd8-e49f-12fa-e063-6394a90aa8a02025-10-24WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEHudson Health LLC36ec5f05-5d1c-25df-e063-6394a90a9dd92025-10-24WarningsExact identifier
application number: M005
Signature Care Antifungal Cream Tolnaftate 1%TOLNAFTATEBETTER LIVING BRANDS LLCb02b81d6-8db4-927b-e053-2995a90a39582025-10-24WarningsExact identifier
application number: M005
Winco Foods TolnaftateTOLNAFTATEWinco Foods, LLC218f7613-1401-4f1b-bf46-576b536825af2025-10-23WarningsExact identifier
application number: M005
zourunan MULTI-PURPOS TREATMENTMULTI-PURPOS TREATMENTGuchutang Biotechnology (Longyan) Co., Ltd41bad254-b674-9521-e063-6294a90ab6342025-10-22WarningsExact identifier
application number: M005
zourunan FOOT ODOR PROBIOTICFOOT ODORGuchutang Biotechnology (Longyan) Co., Ltd41bbc02c-53f2-2d94-e063-6394a90ac9ec2025-10-22WarningsExact identifier
application number: M005
Signature Care Athletes FootCLOTRIMAZOLESafewayc1750c17-4afb-aecf-e053-2a95a90af35b2025-10-22WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATEImperial Feet B.V.1189c7d8-7c8f-ae01-e063-6294a90ac2702025-10-21WarningsExact identifier
application number: M005
Fungicure Liquid GelCLOTRIMAZOLEKobayashi Healthcare International, Inc.dfd03852-29bd-4e16-97f3-64dfde5f8ff82025-10-21WarningsExact identifier
application number: M005
Athlete Foot Medicated barTOLNAFTATEBeautivity LLC3b2cedb2-18f4-f571-e063-6394a90a64182025-10-21WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATEQuantum, Inc.6cb95707-9831-41f1-a23e-9e3356141fdc2025-10-20WarningsExact identifier
application number: M005
Toe FungusTOLNAFTATEImperial Feet B.V.118a6c97-4e8a-050a-e063-6294a90a11082025-10-17WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALTOLNAFTATEGuangzhou Haishi Biological Technology Co., Ltd.4141574d-7a5b-c437-e063-6394a90aacb62025-10-16WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYHY-VEE, INC415ecf9b-460d-82b6-e063-6294a90a0e052025-10-16WarningsExact identifier
application number: M005
SEACALL NAIL REVIVE SERUMNAIL REVIVE SERUMGuangdong Quadrant Ecological Technology Co., Ltd.1f4d0c9a-361e-72e5-e063-6394a90a7cda2025-10-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313423tolnaftate 1 % Topical SolutionPSNb28ee9f2-fc45-4336-b374-be7aa51d44e96
313423tolnaftate 10 MG/ML Topical SolutionSCDb28ee9f2-fc45-4336-b374-be7aa51d44e96
313423tolnaftate 1 % Topical SolutionSYb28ee9f2-fc45-4336-b374-be7aa51d44e96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85477-331-018547703310130 mL in 1 BOTTLE, WITH APPLICATOR (85477-331-01) 30 ml2026-05-01NoNoCurrent