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 47 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aidee198aa1-ad0d-9185-e053-2a95a90a65952024-01-15WarningsExact identifier
application number: M005
Ever Ready HAND SANITIZERETHYL ALCOHOLEver Ready First Aidec1af7ef-3c95-9c60-e053-2a95a90acf472024-01-15WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERETHYL ALCOHOLSled Distribution, LLCe7451738-75d5-5dc4-e053-2a95a90a7aee2024-01-15WarningsExact identifier
application number: M005
Medical SuperALCOHOLBeijing HKKY Medical Tech. Co., Ltd.ed2649c6-d971-4338-8745-cd0a40f7b0c22024-01-13WarningsExact identifier
application number: M005
ER Hand Sanitizer PacketsALCOHOLEVER READY FIRST AIDd0b6d09c-26e0-45c7-8d37-7d42143b2e312024-01-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEProficient Rx LPeeb241a3-93ee-4b74-8cbb-65713d15e7e02024-01-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEProficient Rx LPba1dc4a4-073f-4f30-bb9c-9ed0437004312024-01-01WarningsExact identifier
application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEProficient Rx LP7c64553b-589c-4e65-a6f0-b2847bbbe8a62024-01-01WarningsExact identifier
application number: M005
Dr. Scholls Instant Cool Athletes foot treatment with MentholTOLNAFTATEScholl's Wellness Companydad00745-e411-35b8-e053-2a95a90a10002023-12-21WarningsExact identifier
application number: M005
TINEACIDETOLNAFTATEBlaine Labs Inc.273eb424-5dc3-40c8-9ea7-2f732cbd11c92023-12-21WarningsExact identifier
application number: M005
TERPENICOL ANTIFUNGALUNDECYLENIC ACIDBlaine Labs Inc.a020334e-aac9-4ea5-a0ea-8e5b021fe2eb2023-12-21WarningsExact identifier
application number: M005
TERPENICOLUNDECYLENIC ACIDBlaine Labs Inc.efd99ed1-07d3-4862-ae47-883f7d1c91c62023-12-21WarningsExact identifier
application number: M005
sunmark antifungalTOLNAFTATEA-S Medication Solutions6f85fbb0-297c-4949-83f2-ed9a521721542023-12-16WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7a0ef38a-9584-4e67-ba86-c31f86da1ed02023-12-11WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7d284f6f-a970-49fe-b45a-d5c6c2688bc22023-12-11WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.2096e241-3ed3-49cd-88c4-71db1fd2934a2023-12-06WarningsExact identifier
application number: M005
Undecylenic AcidUNDECYLENIC ACIDChemco Corporation7391b53f-5567-1f45-e053-2991aa0a4fce2023-12-05WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.be92b480-56e8-4371-adbc-40fe74f6747c2023-12-01WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb4c4240f-f84c-ec5e-e053-2a95a90aa0822023-11-17WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb564f971-2a9b-a605-e053-2995a90aee692023-11-17WarningsExact 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