FDA.reportPublic FDA data

Tolnaftate

Product NDC
11527-051
11-digit product format
115270051
Labeler code
11527
Product ID
11527-051_b4271182-7791-423e-8335-dfd5cb5d859b
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Sheffield Pharmaceuticals LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-10-07
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Tolnaftate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

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
103951Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca52af37-c3a2-414c-a24a-a37a92925133Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-051-40Tolnaftate1 in 1 CARTONCREAM15
11527-051-40Tolnaftate35.4 g in 1 TUBECREAM35.45
11527-051-51Tolnaftate1 in 1 CARTONCREAM15
11527-051-51Tolnaftate14 g in 1 TUBECREAM145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-051-40GM - Gram11527-051fb4787af-9168-47e7-a878-1188c3b9e8b412021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVTOLNAFTATE CREAM [FARIA LIMITED DBA SHEFFIELD PHARMACEUTICALS]1
TOLNAFTATEACTIVE MOIETY06KB629TKVTOLNAFTATE CREAM [FARIA LIMITED DBA SHEFFIELD PHARMACEUTICALS]1
CETETH-20INACTIVE INGREDIENTI835H2IHHXTOLNAFTATE CREAM [FARIA LIMITED DBA SHEFFIELD PHARMACEUTICALS]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1STOLNAFTATE CREAM [FARIA LIMITED DBA SHEFFIELD PHARMACEUTICALS]1
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109TOLNAFTATE CREAM [FARIA LIMITED DBA SHEFFIELD PHARMACEUTICALS]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTOLNAFTATE CREAM [FARIA LIMITED DBA SHEFFIELD PHARMACEUTICALS]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTOLNAFTATE CREAM [FARIA LIMITED DBA SHEFFIELD PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TOLNAFTATE CREAM [FARIA LIMITED DBA SHEFFIELD PHARMACEUTICALS]1
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSINACTIVE INGREDIENTKH7I04HPUUTOLNAFTATE CREAM [FARIA LIMITED DBA SHEFFIELD PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RTOLNAFTATE CREAM [FARIA LIMITED DBA SHEFFIELD PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-051TOLNAFTATE CREAM [SHEFFIELD PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 4 package rows20250223_ca52af37-c3a2-414c-a24a-a37a92925133.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 35 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNMARK MICONAZOLE NITRATE antifungalMICONAZOLE NITRATEStrategic Sourcing Services LLC7c15d95a-5b89-4789-8c91-3f61d7ec77072025-07-30WarningsExact identifier
application number: M005
AntifungalMICONAZOLE NITRATEAdvanced Rx LLCe13eb653-3916-444a-ae86-1738c0308b792025-07-28WarningsExact identifier
application number: M005
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.a2b9570f-312c-4f46-994d-efe057b247aa2025-07-28WarningsExact identifier
application number: M005
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.b41b130f-48fd-47d4-a94e-74433ae44de22025-07-28WarningsExact identifier
application number: M005
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLEPreferred Pharmaceuticals Inc.bd567e91-7152-4612-83e0-8e8a00c2d2c52025-07-25WarningsExact identifier
application number: M005
HongocuraUNDECYLENIC ACID, ZINC UNDECYLENATEMENPER DISTRIBUTORS, INC.c69b735e-0ffe-4328-bd9f-3c1ac6798c082025-07-22WarningsExact identifier
application number: M005
Hongocura PinceladasUNDECYLENIC ACIDMenper Distributors, Inc.4b9a3a70-d646-47c6-b969-5c4d759d23a42025-07-22WarningsExact identifier
application number: M005
Hongocura MUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.b4adb7b0-59b4-4b3c-9b0e-1869bb5431742025-07-22WarningsExact identifier
application number: M005
Hongocura SUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.4a21f371-bfc1-4e66-af16-55b3283872b72025-07-22WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 1ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a37a3a8-9d05-926c-e063-6294a90a9ed82025-07-18WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 4ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a382b79-dde9-dde0-e063-6294a90a53bb2025-07-18WarningsExact identifier
application number: M005
FifthPulse clotrimazole cream 4ozCLOTRIMAZOLE 1%Front Pharmaceutical PLC3a389093-48f2-29cb-e063-6294a90ada372025-07-18WarningsExact identifier
application number: M005
PHARMBANNER Tea Tree Oil Antifungal Soap.TEA TREE OIL ANTIFUNGAL SOAP.Shenzhen Xinxin Yunhai Technology Co., Ltd.3a0860b0-346e-7024-e063-6394a90ace812025-07-16WarningsExact identifier
application number: M005
TopCare AntifungalCLOTRIMAZOLETopco Associates LLC6757eb2a-73e0-4bd0-a332-5713fdf3445d2025-07-16WarningsExact identifier
application number: M005
UpandUp ClotrimazoleCLOTRIMAZOLETarget Corporationcb2b7d38-9988-493b-9843-56c2f59eed2f2025-07-16WarningsExact identifier
application number: M005
Jock ItchCLOTRIMAZOLETARGET Corporation1ae551e7-69de-4eef-b4f7-5e1a880e631d2025-07-16WarningsExact identifier
application number: M005
Athletes FootCLOTRIMAZOLEFRED'S, INC.d2d8f44e-2dfa-446b-855e-86e0d6d2d0df2025-07-15WarningsExact identifier
application number: M005
Tolnaftate AntifungalTOLNAFTATESTRATEGIC SOURCING SERVICES LLC97ffb6fd-5670-4783-b805-88fe9e43ca962025-07-15WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESTRATEGIC SOURCING SERVICES LLC966a1000-3b08-4f2c-a9f8-568f2524b7172025-07-15WarningsExact identifier
application number: M005
Tolnaftate AntifungalTOLNAFTATEAmerisource Bergena3c9b783-4a36-46b3-a0dc-0696907eaebb2025-07-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSNca52af37-c3a2-414c-a24a-a37a929251335
103951tolnaftate 10 MG/ML Topical CreamSCDca52af37-c3a2-414c-a24a-a37a929251335
103951tolnaftate 1 % Topical CreamSYca52af37-c3a2-414c-a24a-a37a929251335

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-051-40115270051401 TUBE in 1 CARTON (11527-051-40) / 35.4 g in 1 TUBE1 tube2009-10-070000-00-00NoNoCurrent
11527-051-51115270051511 TUBE in 1 CARTON (11527-051-51) / 14 g in 1 TUBE1 tube2009-10-070000-00-00NoNoCurrent