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 25 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Antifungal Maximum StrengthUNDECYLENIC ACIDTOPCO ASSOCIATES LLC7c44fb4e-0eef-4ced-b03f-a02ebe6c02642025-12-22WarningsExact identifier
application number: M005
Fungi Nail Toe and FootTOLNAFTATEKramer Laboratoriesa3ae043b-dc97-449b-b099-70bdf8e924822025-12-19WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLERUGBY LABORATORIES6de9155b-7070-38fd-e053-2a91aa0af6f62025-12-19WarningsExact identifier
application number: M005
HC Max Anti-FungalTOLNAFTATEKramer Laboratoriesee99cd87-549f-4a43-878e-b4d5935de0e02025-12-19WarningsExact identifier
application number: M005
Fungi Nail Anti-Fungal PenTOLNAFTATEKramer Laboratories1a0a3b14-d8f2-4363-b3c9-f5028e8eada32025-12-19WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL POWDER SPRAYWinco Foods, LLCcc257a18-247f-c787-e053-2a95a90a075a2025-12-16WarningsExact identifier
application number: M005
TolnaftateODOR CONTROL POWDER SPRAYWalgreen Companya113f568-bd20-4f02-8e09-1b8223a0a9fa2025-12-16WarningsExact identifier
application number: M005
Tobcharm Toenail Fungus Treatment LiquidTOENAIL FUNGUS TREATMENT LIQUIDGuangzhou Qiexiran Cosmetics Co., Ltd.45f92be2-0677-5989-e063-6394a90af2802025-12-15WarningsExact identifier
application number: M005
TEA TREE Oil ANTIFUNGAL CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD45bd3ad0-a0d1-314f-e063-6394a90a9a3a2025-12-12WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREETopco Associates LLC97334166-1dff-4ed2-ad31-f524b22097f92025-12-12WarningsExact identifier
application number: M005
Foot Odor Control PowderTOLNAFTATEMeijer Distribution Inc03fd2680-0040-aa8c-e063-6294a90a090f2025-12-12WarningsExact identifier
application number: M005
Foot Odor Control PowderTOLNAFTATEPremier Brands of America Inc.edb0a2da-aaa1-3b9b-e053-2995a90a50122025-12-12WarningsExact identifier
application number: M005
PedikleerTOLNAFTATERising Pharma Holdings, Inc.83396c51-7107-4d98-9d80-ebf6584f4dc82025-12-11WarningsExact identifier
application number: M005
ELAIMEI FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.457d08eb-e812-8f12-e063-6294a90ab85f2025-12-10WarningsExact identifier
application number: M005
Lofuanna FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.43da9ec2-5f2f-dfce-e063-6394a90aecca2025-12-10WarningsExact identifier
application number: M005
WRFAATGO ANTIFUNGAL Pen Undecylenic Acid 25%UNDECYLENIC ACID 25%Shenzhen Shandian Jingling Technology Co., Ltd.457f819b-0850-a97c-e063-6394a90ac3682025-12-09WarningsExact identifier
application number: M005
NAIL REPAIR PENUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd45814b84-0e51-6c9d-e063-6394a90a29052025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATE ANTIFUNGAL POWDER SPRAYBetter Living Brandsccfef81b-f271-4551-e053-2a95a90a8ac42025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREEFoodhold USAa64c9371-0ac7-4c47-bc12-7bc77162b2442025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEHarris Teeter, LLC02eb9c78-5a89-4958-b5a4-68f39e584cf22025-12-09WarningsExact 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