Tolnaftate

Product NDC
63868-798
11-digit product format
638680798
Labeler code
63868
Product ID
63868-798_53d7b662-15a0-8548-e063-6294a90a9ff8
Type
HUMAN OTC DRUG
Nonproprietary name
Antifungal Liquid Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Chain Drug Marketing Association
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-01
Marketing end
2027-11-30
Substance
TOLNAFTATE
Active strength
1.5 g/150g
NDC exclude flag
No
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
Tolnaftate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1.5 g/150g

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
313421Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa97d2ca-bcf4-3ee1-e053-2a95a90a748dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-798-53Tolnaftate150 g in 1 CANAEROSOL, SPRAY1506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-798-53GM - Gram63868-79823248be6-7c4f-4458-8d69-f10958a99d4d12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-798TOLNAFTATE (ANTIFUNGAL LIQUID SPRAY) AEROSOL, SPRAY [CHAIN DRUG MARKETING ASSOCIATION]6Current NDC, Legacy NDC, 1 package rows20241213_aa97d2ca-bcf4-3ee1-e053-2a95a90a748d.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 8 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC30dca43e-e6c4-8107-e063-6394a90a2b972026-07-01WarningsExact identifier
application number: M005
Fungi Nail Everyday Antifungal PowderTOLNAFTATEKramer Laboratories8ed1a08a-3019-4564-968f-154e659c05e12026-07-01WarningsExact identifier
application number: M005
Terpenicol Antifungal SolutionMICONAZOLE NITRATEBlaine Labs Inc.f17ef2cd-5923-4df5-a7fe-aeef167e1e862026-07-01WarningsExact identifier
application number: M005
LUMUMU TOENAIL REPAIR PENUNDECYLENIC ACID 25% TOENAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.55763ee1-a775-731c-e063-6394a90a8f4c2026-06-30WarningsExact identifier
application number: M005
Kopa Haiku Ringworm Treatment CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd52cef8ec-6578-5e80-e063-6294a90ab4232026-06-30WarningsExact identifier
application number: M005
Tinea Versicolor Treatment CreamCLOTRIMAZOLEBeautivity LLC32d71d7e-3c78-6b63-e063-6294a90adaed2026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment BarCLOTRIMAZOLEBeautivity LLC33612382-2f12-e9f6-e063-6394a90aaee42026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment KitCLOTRIMAZOLEBeautivity LLC3361d9a2-daf6-7749-e063-6294a90a36532026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal treatment creamCLOTRIMAZOLE 1%Beautivity LLC3c9bd942-49c6-cada-e063-6394a90a31662026-06-29WarningsExact identifier
application number: M005
Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate CreamTOLNAFTATE 1%Beautivity LLC4141cca0-1650-6e00-e063-6394a90a13e32026-06-29WarningsExact identifier
application number: M005
Athlete Foot Treatment KitTERBINAFINE HYDROCHLORIDE, TOLNAFTATEBeautivity LLC3b3aa69f-4e73-cabc-e063-6294a90ab65b2026-06-29WarningsExact identifier
application number: M005
Athlete Foot CreamTERBINAFINE HYDROCHLORIDEBeautivity LLC3b2c1d7f-32c3-aa3b-e063-6394a90a62672026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal soap. barCLOTRIMAZOLE 1%Beautivity LLC3cdcf8cc-510c-6115-e063-6294a90ac3ea2026-06-29WarningsExact identifier
application number: M005
Clotrimazole antifungal treatment kitCLOTRIMAZOLE 1%Beautivity LLC3ceec52e-4089-9eb0-e063-6294a90ad52a2026-06-29WarningsExact identifier
application number: M005
Ringworm Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4805462b-aec6-78fe-e063-6394a90ae0662026-06-29WarningsExact identifier
application number: M005
Hermon Athletes foot Tolnaftate 1% kitTOLNAFTATE 1% KITBeautivity LLC4142f490-c4b5-a9f3-e063-6394a90ab75e2026-06-29WarningsExact identifier
application number: M005
Aosorw Antifungal CreamMICONAZOLE NITRATE 2%SpineStatus LLC31f4b0eb-b8aa-7ccb-e063-6394a90ad9812026-06-29WarningsExact identifier
application number: M005
VORVITA Nail HardenerPANTHENOL,HYALURONIC ACIDHK Vorvita Technology Co., Limited51d5d3c7-ca25-3ee5-e063-6294a90a3a052026-06-26WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLC55210a9d-6c47-4fc7-e063-6294a90a36532026-06-25WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail Repair PenFUNGAL NAIL REPAIR PENGuangzhou Jingliang Cosmetics Co., Ltd.5500b582-0641-498d-e063-6394a90a3c582026-06-24WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313421tolnaftate 1 % Topical SprayPSNaa97d2ca-bcf4-3ee1-e053-2a95a90a748d6
313421tolnaftate 10 MG/ML Topical SpraySCDaa97d2ca-bcf4-3ee1-e053-2a95a90a748d6
313421tolnaftate 1 % Topical SpraySYaa97d2ca-bcf4-3ee1-e053-2a95a90a748d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-798-5363868079853150 g in 1 CAN (63868-798-53) 150 g2014-12-012027-11-30NoNoCurrent