FDA.reportPublic FDA data

Tolnaftate Cream 1% ANTIFUNGAL

Product NDC
69396-016
11-digit product format
693960016
Labeler code
69396
Product ID
69396-016_352f8de3-8ff3-4098-e063-6294a90ace4d
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals Usa Llc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-09
Substance
TOLNAFTATE
Active strength
1 g/100g
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 Cream 1% ANTIFUNGAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100g

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
96a40ccd-17f7-4e4e-98da-207802fa2b2dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-016-05Tolnaftate Cream 1% ANTIFUNGAL1 in 1 BOXCREAM18
69396-016-05Tolnaftate Cream 1% ANTIFUNGAL15 g in 1 TUBECREAM158
69396-016-20Tolnaftate Cream 1% ANTIFUNGAL1 in 1 BOXCREAM18
69396-016-20Tolnaftate Cream 1% ANTIFUNGAL30 g in 1 TUBECREAM308
69396-016-33Tolnaftate Cream 1% ANTIFUNGAL30 g in 1 TUBECREAM308
69396-016-33Tolnaftate Cream 1% ANTIFUNGAL3 in 1 BOXCREAM38
69396-016-66Tolnaftate Cream 1% ANTIFUNGAL30 g in 1 TUBECREAM308
69396-016-66Tolnaftate Cream 1% ANTIFUNGAL6 in 1 BOXCREAM68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-016-20GM - Gram69396-016aa3c307b-f4ba-43f9-a916-a7f90c07798712018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-016TOLNAFTATE CREAM 1% ANTIFUNGAL (TOLNAFTATE) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]8Current NDC, Legacy NDC, 8 package rows20250516_96a40ccd-17f7-4e4e-98da-207802fa2b2d.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 46 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEASTONEA LABS PRIVATE LIMITEDe66191a6-0c3c-7319-e053-2a95a90aae842024-06-25WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsb63a3fe5-5684-41bc-ad6c-69c54e5b942d2024-06-20WarningsExact identifier
application number: M005
THERA Antifungal BodyMICONAZOLE NITRATEMcKesson Medical-Surgical Inc.31096041-28c9-4b16-bbd1-dbadefd375052024-06-14WarningsExact identifier
application number: M005
Antifungal BodyMICONAZOLE NITRATEMcKesson4fb9aece-0baa-475e-e054-00144ff8d46c2024-06-13WarningsExact identifier
application number: M005
Secura ProtectiveZINC OXIDESmith & Nephew Medical Ltdb077aa64-49a3-42ee-abb3-88f833635b932024-06-12WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.627375fb-2f20-16bc-e053-2a91aa0a15422024-06-06WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLECardinal Health 110 dba LEADER199df107-3384-6e03-e063-6294a90afc382024-05-29WarningsExact identifier
application number: M005
FemmesilCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCefddad82-9dc7-4cd9-b33c-7e85f30d992e2024-05-24WarningsExact identifier
application number: M005
Anti-FungalMICONAZOLE NITRATEUniversal Distribution Center LLC8f316b0d-d308-4ae6-82c4-39bb0d1d474e2024-05-21WarningsExact identifier
application number: M005
CANESPIESTOLNAFTATEOPMX LLCe2f9eedc-3c43-416b-85b5-ba07fb5fb4db2024-05-17WarningsExact identifier
application number: M005
Up and Up AntifungalTOLNAFTATE 1%Target Corporation8f54c8c7-6771-49c3-b429-53aa6df54dc52024-05-08WarningsExact identifier
application number: M005
Up and Up Athletes FootCLOTRIMAZOLE 1%Target Corporation52b61859-11ae-4990-aa0c-9dc1dd00adf42024-05-08WarningsExact identifier
application number: M005
ADI Medical PVP-I Pouch, FoilPOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0e8baf24-0c67-5511-e063-6394a90acaa12024-05-02WarningsExact identifier
application number: M005
Caseys Antimicrobial Hand SanitizerETHYL ALCOHOLNavajo Manufacturing Company Inc.78863024-390c-4ff9-8ed6-02af07902a302024-04-29WarningsExact identifier
application number: M005
MQUPIN Liquid Fungal Nail TreatmentLIQUID FUNGAL NAIL TREATMENTZhengzhou Miaoqi Medical Technology Co., Ltd.14782f8c-3b29-1d88-e063-6294a90ac3e42024-03-25WarningsExact identifier
application number: M005
ETADERM Advanced Antifungal SupportUNDECYLENIC ACIDNUEPHASE LLCadb12a1c-ece9-4a59-a62c-89d212c57e6f2024-03-13WarningsExact identifier
application number: M005
Dermachange JockMICONAZOLE NITRATEPrivate label Beauty and Wellness12eef049-76c9-1450-e063-6394a90a00ea2024-03-05WarningsExact identifier
application number: M005
Clotrimazole AntifungalCLOTRIMAZOLETrifecta Pharmaceuticals USA, LLC.11bf50db-552e-0a39-e063-6394a90af60d2024-02-19WarningsExact identifier
application number: M005
TOLNAFTATE ANTIFUNGALTOLNAFTATEBryant Ranch Prepackfbbd159c-217e-46d3-963c-ba0bd1e9bbe82024-01-29WarningsExact identifier
application number: M005
Target Jock ItchCLOTRIMAZOLE 1%Target Corporationf44d4c44-99d1-413f-b9c3-8330bdd21abb2024-01-17WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSN96a40ccd-17f7-4e4e-98da-207802fa2b2d8
103951tolnaftate 10 MG/ML Topical CreamSCD96a40ccd-17f7-4e4e-98da-207802fa2b2d8
103951tolnaftate 1 % Topical CreamSY96a40ccd-17f7-4e4e-98da-207802fa2b2d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-016-05693960016051 TUBE in 1 BOX (69396-016-05) / 15 g in 1 TUBE1 tube2016-04-090000-00-00NoNoCurrent
69396-016-20693960016201 TUBE in 1 BOX (69396-016-20) / 30 g in 1 TUBE1 tube2016-04-090000-00-00NoNoCurrent
69396-016-33693960016333 TUBE in 1 BOX (69396-016-33) / 30 g in 1 TUBE3 tube2025-05-15NoNoCurrent
69396-016-66693960016666 TUBE in 1 BOX (69396-016-66) / 30 g in 1 TUBE6 tube2023-06-20NoNoCurrent