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 34 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlyCylicSALICYLIC ACIDThe Tetra Corporation501d3ba9-ba42-4c1c-983b-492adaee039d2025-08-18WarningsExact identifier
application number: M005
SupreH Ringworm Treatment BalmSUPREH RINGWORM TREATMENT BALMShenzhen Xinxin Yunhai Technology Co., Ltd.3c77222b-d92e-84b0-e063-6294a90aadd72025-08-16WarningsExact identifier
application number: M005
OetMoe Antifungal SolutionOETMOE ANTIFUNGAL SOLUTIONShenzhen Earth Surface Trading Co., Ltd.3c26d917-4186-6f02-e063-6394a90a99f62025-08-12WarningsExact identifier
application number: M005
Cureforte Anti Fungal Foot CareANTI FUNGAL FOOT CARE DROPSSTEEL CITY HEALTH PRIVATE LIMITED39f762a6-9d0c-8ded-e063-6394a90a36592025-08-11WarningsExact identifier
application number: M005
Derman Antifungal Powder TolnaftateTOLNAFTATETaisho Pharmaceutical California Inc.3a854765-740c-4719-8abf-4b3f932cdee02025-08-07WarningsExact identifier
application number: M005
Derman antifungal creamTOLNAFTATETaisho Pharmaceutical California Inc.15d9b3c9-01af-4083-a1bc-014505d8798d2025-08-07WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEHudson Health LLC24b22794-f9f8-6f32-e063-6394a90aec982025-08-07WarningsExact identifier
application number: M005
Toe Area TreatmentTOLNAFTATECVS17681cc8-fbb1-a0cf-e063-6294a90add182025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc178e7b3f-949f-3f51-e063-6294a90a93952025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATELEADER/Cardinal Health 110, Inc.17695563-3765-74cb-e063-6294a90a61202025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETarget Corporation1dff278f-47bc-459a-e063-6394a90a26462025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETopCo Associates19c268a1-7b2e-63c9-e063-6394a90acddc2025-08-07WarningsExact identifier
application number: M005
Antifungal Liquid Maximum StrengthTOLNAFTATEWalgreens Company137eabb7-cb4f-1631-e063-6294a90ab8472025-08-07WarningsExact identifier
application number: M005
WCTNGO Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad0d73-b33d-b962-e063-6294a90a7ba72025-08-06WarningsExact identifier
application number: M005
ONIADBA Nail Fungus Treatment PenTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad19f1-d5b3-c5de-e063-6294a90a0c032025-08-06WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEPremier Brands of America Inc2644ba07-aaee-6402-e063-6394a90a28272025-08-06WarningsExact identifier
application number: M005
Anti- Fungal Miconazole NitrateMICONAZOLE NITRATEPremier Brands of America Inc.f186bdc1-db6c-0fab-e053-2995a90a7c582025-08-06WarningsExact identifier
application number: M005
ONIADBA Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3baa99ab-6d22-8d7d-e063-6294a90af3e82025-08-05WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.cca84334-2e2d-4991-9d1e-d5b7c9ffd3922025-08-01WarningsExact identifier
application number: M005
RoyceDerm CoolDefense Refreshing Shower GelTOLNAFTATE 1.0%RoyceDerm LLC3b3216d6-8cc8-ea89-e063-6294a90ab6912025-07-31WarningsExact 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