FDA.reportPublic FDA data

Tolnaftate Cream 1% ANTIFUNGAL

Product NDC
69396-016
Requested package NDC
69396-016-33
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 37 of 49 · 967 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.a3a5cbf5-cabb-48d8-8877-74a97f7c0f572025-07-03WarningsExact identifier
application number: M005
OMZOK ANTIFUNGAL PENUNDECYLENIC ACID 25%Shenzhen Shandian Jingling Technology Co., Ltd.38edf699-93af-e550-e063-6294a90a368c2025-07-02WarningsExact identifier
application number: M005
meijer Athletes FootCLOTRIMAZOLEMeijer Distribution Incfdb15cd8-6726-4150-9b9d-6ef3ee01a5d22025-07-02WarningsExact identifier
application number: M005
meijer antifungalTOLNAFTATEMeijer Distribution Inc374af35a-b8bb-4784-bfc8-c3342de875ca2025-07-02WarningsExact identifier
application number: M005
Rexall Jock ItchCLOTRIMAZOLEDollar General11427a79-f262-4702-9b2e-ec1955a9b2da2025-07-02WarningsExact identifier
application number: M005
Rexall Athletes FootCLOTRIMAZOLEDollar General664579a1-a5b0-4a4c-bff6-4347f3e1d3bb2025-07-02WarningsExact identifier
application number: M005
Athletes Foot AntifungalTOLNAFTATEDollar General43fc473e-c1fd-4245-af38-2e9de5ad91dc2025-07-02WarningsExact identifier
application number: M005
SEFUDUN FUNGAL NAIL PATCHESGLYCERINShenzhen Shandian Jingling Technology Co., Ltd.38db97d6-27c8-da99-e063-6294a90aac662025-07-01WarningsExact identifier
application number: M005
Tolnaftate AntifungalTOLNAFTATESun Pharmaceutical Industries, Inc.fa16fa08-fbbd-4f45-b64a-9bffe78e88612025-07-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEGranules Pharmaceuticals Inc.1280353c-9f96-557e-e063-6294a90a10f92025-06-30WarningsExact identifier
application number: M005
MiconazoleMICONAZOLE NITRATEChain Drug Consortium, LLC246be926-79ea-4e0c-a3ef-2aa7fc3a52bf2025-06-30WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL LIQUID CONTINUOUS SPRAYChain Drug Consortium, LLC7f6912a6-a576-4138-bd78-a075a7d240362025-06-27WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYRite Aid Corporationaee58c44-5dba-8acb-e053-2a95a90a23af2025-06-21WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREERite Aid Corporation5e2f2372-4b79-4b6a-bdea-74289b1e20532025-06-21WarningsExact identifier
application number: M005
TolnaftateJOCK ITCH POWDERRite Aid Corporationb6968587-45c2-d2f8-e053-2a95a90a84012025-06-21WarningsExact identifier
application number: M005
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd67d1d65a-71d4-41fc-a71c-85a28ce6de0c2025-06-18WarningsExact identifier
application number: M005
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd640df217-6982-441e-835a-dbe2031e732b2025-06-18WarningsExact identifier
application number: M005
EYELID WIPESEYELID WIPESShenzhen Shierjie Biological Engineering Co., LTD377fb842-aa78-ab2a-e063-6394a90a69f92025-06-13WarningsExact identifier
application number: M005
Lunavia Antifungal Foot BalmZINC UNDECYLENATE 10%XF Agencija Limited466f3285-9800-4219-902f-b78a713b952f2025-06-13WarningsExact identifier
application number: M005
Foot Cure Antifungal Foot BalmZINC UNDECYLENATESansar LLCac6075bf-cc1d-4e8a-aa13-5a85e80f34ee2025-06-13WarningsExact 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 startSampleExclude flagStatus
69396-016-33693960016333 TUBE in 1 BOX (69396-016-33) / 30 g in 1 TUBE3 tube2025-05-15NoNoCurrent