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 23 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hermon Antifungal Cleansing BarTOLNAFTATE 1%Beautivity LLC48b5d7b3-a134-ecdd-e063-6294a90a32132026-01-18WarningsExact identifier
application number: M005
ANTIFUNGAL TOENAIL FUNGUS PENUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd48b5fbd9-bdf5-21ac-e063-6394a90aa6b62026-01-18WarningsExact identifier
application number: M005
Hermon Antifungal Soap.TOLNAFTATE 1%Beautivity LLC41e37014-549c-e592-e063-6294a90ac6ab2026-01-17WarningsExact identifier
application number: M005
Hermon Antifungal .soap.TOLNAFTATE 1%Beautivity LLC482c338f-870f-f6d7-e063-6394a90a432c2026-01-17WarningsExact identifier
application number: M005
MEOLY Fungal Nail RenewalFUNGAL NAIL RENEWALShenzhen Xinxin Yunhai Technology Co., Ltd.487d2e22-6328-893f-e063-6394a90a9dff2026-01-16WarningsExact identifier
application number: M005
Lotrimin AntifungalMICONAZOLE NITRATEBayer HealthCare LLC.cebd222c-074f-443c-bd37-612114b27bbd2026-01-16WarningsExact identifier
application number: M005
Lotrimin Daily PreventionTOLNAFTATEBayer HealthCare LLC.9e8f9211-e85d-725a-e053-2995a90a09b32026-01-16WarningsExact identifier
application number: M005
Lotrimin AF Jock ItchMICONAZOLE NITRATEBayer HealthCare LLC.1300d84f-d7ff-ec57-e063-6294a90ae0de2026-01-16WarningsExact identifier
application number: M005
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEELALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4868de4b-65ea-01ed-e063-6294a90ae5512026-01-15WarningsExact identifier
application number: M005
Antifungal Ringworm TreatmentMICONAZOLE NITRATERida LLCeb953281-cf86-44cf-a3d1-37b8d344a6bc2026-01-15WarningsExact identifier
application number: M005
ElixirTripleGuard Triple AntibioticMICONAZOLE NITRATE CREAMELIXIR HEALTHCARE USA, LLC.0482ce9f-c98a-4f37-8b37-6df1738b6da32026-01-15WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER SANTAL WAVE 35mlALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA483f3199-7357-112c-e063-6394a90aafa42026-01-14WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA48555528-bbbc-ccef-e063-6294a90a66092026-01-14WarningsExact identifier
application number: M005
HERMON ANTIFUNGAL BARTOLNAFTATEHaikou Pucao Trading Co.,Ltd2da7a20e-021e-2111-e063-6294a90ad4412026-01-14WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MISTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4866d108-0bbb-12bf-e063-6394a90a338c2026-01-14WarningsExact identifier
application number: M005
Hermon Ringworm Treatment Body WashTOLNAFTATE 1%Beautivity LLC48417be9-7cc0-e2f3-e063-6294a90aa2a22026-01-13WarningsExact identifier
application number: M005
Kerasal Athletes Foot powderTOLNAFTATEAdvantice Health, LLC470d8424-21b8-48e5-8f33-e8baf65c2fb02026-01-13WarningsExact identifier
application number: M005
DesenexMICONAZOLE NITRATECrown Laboratories09964187-12f1-bbe6-e063-6394a90acba02026-01-12WarningsExact identifier
application number: M005
Zeasorb Jock ItchMICONAZOLE NITRATECrown Laboratories09d088ef-aab3-5565-e063-6394a90af2632026-01-12WarningsExact 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