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 39 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ELLEN HAND SANITIZER2ETHYL ALCOHOLPT. SUPER HOME PRODUCT INDONESIA334574b6-6d4a-bd37-e063-6394a90a67d62025-04-21WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEGERI-GENTLE CORPORATIONe6734616-c16b-430c-e053-2a95a90a18f82025-04-21WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLEGERI-GENTLE CORPORATIONe673748f-d00b-4ce8-e053-2995a90a92202025-04-21WarningsExact identifier
application number: M005
PHYTOZINE RINGWORM TREATMENT MAXIMUM STRENGTHTOLNAFTATEThe Sisquoc Healthcare Corporation5dff6ee7-f7a9-4841-8357-6b0801d253f12025-04-21WarningsExact 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