FDA.reportPublic FDA data

Dryello Tolnaftate 1% Antifungal

Product NDC
85565-005
11-digit product format
855650005
Labeler code
85565
Product ID
85565-005_5d30cd57-411e-883e-e063-6294a90a76c3
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
STICK
Route
TOPICAL
Labeler
ProPedix, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-03
Marketing end
2028-08-12
Substance
TOLNAFTATE
Active strength
1 g/100g
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
Dryello Tolnaftate 1% Antifungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100g

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
199126Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e962ca4-80ee-a379-e063-6394a90a1322Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85565-005-01Dryello Tolnaftate 1% Antifungal15 g in 1 APPLICATORSTICK151
85565-005-01Dryello Tolnaftate 1% Antifungal2 in 1 BOXSTICK21

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 39 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terrasil Anti-Fungal Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsdb356cc8-f473-4eb2-b8d8-72606fca9dc02025-05-23WarningsExact identifier
application number: M005
terrasil Folliculitis Cream Maximum StrengthCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions35d54756-00dd-bbe1-e063-6394a90a9e022025-05-23WarningsExact identifier
application number: M005
Paume Moisturizing Antibacterial Hand GelALCOHOLPaume Incb6fe12bf-6430-5861-e053-2a95a90a6c8f2025-05-22WarningsExact identifier
application number: M005
Tolnaftate Cream 1% ANTIFUNGALTOLNAFTATETrifecta Pharmaceuticals Usa Llc96a40ccd-17f7-4e4e-98da-207802fa2b2d2025-05-15WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATECardinal Health 110 dba LEADER34f4c733-2eb2-0db0-e063-6394a90a64312025-05-13WarningsExact identifier
application number: M005
Dr CANUSO fungal nail eraserTOLNAFTATE OILRenu Laboratories, LLC2083f9ed-09d6-26e6-e054-00144ff88e882025-05-13WarningsExact identifier
application number: M005
Dr. Canuso foot repair serumTOLNAFTATE SERUMRenu Laboratories, LLC1fcc52c5-7030-13cb-e054-00144ff8d46c2025-05-13WarningsExact identifier
application number: M005
Private Label Antifungal Barrier CreamMICONAZOLE NITRATE ANTIFUNGAL CREAMSwiss-American CDMO, LLC2ee40c37-504b-43ed-960a-5350154074922025-05-09WarningsExact identifier
application number: M005
Osimoon Fungal Nail Treatment KitOSIMOON FUNGAL NAIL TREATMENT KITGuangzhou Zanming Trading Co., Ltd.34aec10d-a0d0-d956-e063-6394a90a39b22025-05-09WarningsExact identifier
application number: M005
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC33d9c724-d4c4-2597-e063-6294a90aa5f32025-04-28WarningsExact identifier
application number: M005
ANTIFUNGALCLOTRIMAZOLEVIVE HEALTH LLC33db98f5-f6d9-742a-e063-6394a90a2a032025-04-28WarningsExact identifier
application number: M005
Foot Cure Nail Repair PenANTIFUNGAL NAIL REPAIR PENSANSAR, LLC9c823e27-8bb3-4ccd-bf7e-a99d45908e882025-04-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER CUCUMBER MELONALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3380404d-9499-e9fb-e063-6394a90a0f272025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER SWEET GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3380fe6d-e059-401a-e063-6394a90a787a2025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3381cefb-281c-9b85-e063-6294a90acfd92025-04-24WarningsExact identifier
application number: M005
Wish Hand Sanitizer Coconut Cream White FloralsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA33826aef-6e50-2730-e063-6394a90a727b2025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER GOLDEN CITRUSALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3391a78e-525d-c2ba-e063-6394a90a1e992025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA33927939-a9dc-ab67-e063-6394a90a71cc2025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT. SUPER HOME PRODUCT INDONESIA336c751f-6a33-ca55-e063-6394a90a97492025-04-23WarningsExact identifier
application number: M005
WISH HAND SANITIZER VIOLET ORCHID SANDALWOODALCOHOL HAND SANITIZERPT. SUPER HOME PRODUCT INDONESIA337e4526-238a-bc2d-e063-6394a90a5a272025-04-23WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199126tolnaftate 1 % Topical OintmentPSN4e962ca4-80ee-a379-e063-6394a90a13221
199126tolnaftate 0.01 MG/MG Topical OintmentSCD4e962ca4-80ee-a379-e063-6394a90a13221
199126tolnaftate 1 % Topical OintmentSY4e962ca4-80ee-a379-e063-6394a90a13221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
85565-005-01855650005012 APPLICATOR in 1 BOX (85565-005-01) / 15 g in 1 APPLICATOR2 applicator2026-04-032028-08-12NoNoCurrent