FDA.reportPublic FDA data

Tolnafate

Product NDC
59779-511
11-digit product format
597790511
Labeler code
59779
Product ID
59779-511_5c2a4196-f306-6863-e063-6394a90aaa2f
Type
HUMAN OTC DRUG
Nonproprietary name
Foot and Sneaker Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-01
Substance
TOLNAFTATE
Active strength
1.3 g/113g
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
Tolnafate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1.3 g/113g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-511-04Tolnafate113 g in 1 CANISTERAEROSOL, SPRAY1139

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVTOLNAFATE (FOOT AND SNEAKER SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
TOLNAFTATEACTIVE MOIETY06KB629TKVTOLNAFATE (FOOT AND SNEAKER SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTOLNAFATE (FOOT AND SNEAKER SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09LTOLNAFATE (FOOT AND SNEAKER SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
ISOBUTANEINACTIVE INGREDIENTBXR49TP611TOLNAFATE (FOOT AND SNEAKER SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSTOLNAFATE (FOOT AND SNEAKER SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOTOLNAFATE (FOOT AND SNEAKER SPRAY) AEROSOL, SPRAY [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-511TOLNAFATE (FOOT AND SNEAKER SPRAY) AEROSOL, SPRAY [CVS PHARMACY]8Current NDC, Legacy NDC, 1 package rows20241115_81e3cdca-cc97-4afe-911a-d7b7c3640370.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 14 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories, Inc.2c60e631-5930-4420-886d-eb1990c720b62026-05-11WarningsExact identifier
application number: M005
TolfyraTOLNAFTATEOncora Pharma, LLCb28ee9f2-fc45-4336-b374-be7aa51d44e92026-05-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsc0f58a0d-a304-41f9-bbdf-c2e488230cf02026-05-11WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd5148b838-d26e-cf66-e063-6394a90ae4692026-05-09WarningsExact identifier
application number: M005
HuiPoLii NAIL PFLASTERTOLNAFTATE 1% NAIL PFLASTERJiangxi Yudexi Pharmaceutical Co., LTD514b1c2d-cecb-30a2-e063-6394a90af2662026-05-08WarningsExact identifier
application number: M005
Recuren Plus Jock Itch CreamMICONAZOLE NITRATE 2%REGENEREN PLUS LTD450dab4d-168a-60b8-e063-6394a90ab3032026-05-08WarningsExact identifier
application number: M005
OSIMOON FUNGAL NAIL TREATMENT KitFUNGAL NAIL TREATMENT KITGuangzhou Jingliang Cosmetics Co., Ltd.51465ebf-3b5f-e2bf-e063-6394a90adaf22026-05-07WarningsExact identifier
application number: M005
RoyceDerm Tinea Antifungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC40089a7d-c893-4e90-e063-6294a90aa6f92026-05-06WarningsExact identifier
application number: M005
QQE Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.510ff705-e2cb-b77b-e063-6394a90a9e722026-05-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEAkron Pharma Inc692d7e0f-50d4-4abb-8c74-36bc98064fe72026-05-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEKJD Pharma Private Limited5115f8e3-5668-5207-e063-6394a90a76502026-05-05WarningsExact identifier
application number: M005
NATURAL CURES FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESJiangxi Yudexi Pharmaceutical Co., LTD510a8df7-ea6d-d634-e063-6294a90aea532026-05-04WarningsExact identifier
application number: M005
Hand Sanitizer Lemon ScentedALCOHOLTaizhou Juheng Biotechnology Co., Ltd.21387234-0ac9-499d-97bf-90bccc4782ad2026-05-04WarningsExact identifier
application number: M005
Uauko Fungal Nail TreatmentFUNGAL NAIL TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.50d16854-ab90-d6cf-e063-6294a90a21b12026-05-02WarningsExact identifier
application number: M005
NAIL RENEWTOLNAFTATENailrenew Corpa0df4ee5-1276-41b7-a1c4-8fcbfc7f97b52026-05-02WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEELALCOHOL HAND SANITIZER SPRAYCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4934c20d-6295-aeb8-e063-6394a90adfeb2026-04-30WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSE 35mlALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4931f2e4-0fef-a8c7-e063-6394a90ac16e2026-04-30WarningsExact identifier
application number: M005
MINADCIN TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD50a9264e-aba0-0ae2-e063-6294a90acfff2026-04-30WarningsExact identifier
application number: M005
ANTIFUNGALUNDECYLENIC ACIDChemco Corporation50893584-c1c6-9ffa-e063-6394a90ae1772026-04-29WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MISTALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.50949ae2-3ebe-08d2-e063-6394a90a20462026-04-29WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-511-0459779051104113 g in 1 CANISTER (59779-511-04) 113 g2014-01-010000-00-00NoNoCurrent