FDA.reportPublic FDA data

Tolnafate

Product NDC
68016-653
11-digit product format
680160653
Labeler code
68016
Product ID
68016-653_4aa5f166-0e54-6d6c-e063-6394a90a8a62
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate Jock Itch Powder Spray - Talc Free
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Chain Drug Consortium, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-31
Marketing end
2028-06-30
Substance
TOLNAFTATE
Active strength
1.3 g/130g
NDC exclude flag
No
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
Tolnafate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1.3 g/130g

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
705934Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f9edcf9-b99e-65a2-e053-2a91aa0af565Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-653-46Tolnafate130 g in 1 CANAEROSOL, SPRAY1309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-653TOLNAFATE (TOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREE) AEROSOL, SPRAY [CHAIN DRUG CONSORTIUM, LLC]6Current NDC, Legacy NDC, 1 package rows20241220_5f9edcf9-b99e-65a2-e053-2a91aa0af565.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 40 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antifungal Boday WashTOLNAFTATECAVTECH HOLDING LLC3619d717-fe42-412f-e063-6394a90a03842025-05-27WarningsExact identifier
application number: M005
Toenail Fungus LiquidTOENAIL FUNGUS LIQUIDShenzhen Earth Surface Trading Co., Ltd.361f4c5c-7fa7-0440-e063-6294a90aad9f2025-05-27WarningsExact identifier
application number: M005
help it AntisepticBENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b22f423-eb11-445f-a484-9326c1fe3ad52025-05-27WarningsExact identifier
application number: M005
Seacall Hydrocortisone Ointment.SEACALL HYDROCORTISONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.3616980a-03dc-deba-e063-6394a90a6ce72025-05-26WarningsExact identifier
application number: M005
Terrasil Anti-Fungal Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsdb356cc8-f473-4eb2-b8d8-72606fca9dc02025-05-23WarningsExact identifier
application number: M005
terrasil Folliculitis Cream Maximum StrengthCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions35d54756-00dd-bbe1-e063-6394a90a9e022025-05-23WarningsExact identifier
application number: M005
Paume Moisturizing Antibacterial Hand GelALCOHOLPaume Incb6fe12bf-6430-5861-e053-2a95a90a6c8f2025-05-22WarningsExact identifier
application number: M005
Tagrid Jock ItchTOLNAFTATETAGRID LLC35a98b0c-9558-a464-e063-6294a90ab73e2025-05-21WarningsExact identifier
application number: M005
Tagrid Antifungal Ringworm Treatment 1% CLOTRIMAZOLECLOTRIMAZOLETAGRID LLC34af91bb-e04b-d252-e063-6294a90aaf962025-05-20WarningsExact identifier
application number: M005
Tolnaftate Cream 1% ANTIFUNGALTOLNAFTATETrifecta Pharmaceuticals Usa Llc96a40ccd-17f7-4e4e-98da-207802fa2b2d2025-05-15WarningsExact identifier
application number: M005
Tagrid Athletes Foot TreamentTOLNAFTATETAGRID LLC35201d97-23f3-f028-e063-6394a90a9b452025-05-14WarningsExact identifier
application number: M005
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705934tolnaftate 1 % Powder SprayPSN5f9edcf9-b99e-65a2-e053-2a91aa0af5659
705934tolnaftate 0.01 MG/MG Powder SpraySCD5f9edcf9-b99e-65a2-e053-2a91aa0af5659
705934tolnaftate 1 % Powder SpraySY5f9edcf9-b99e-65a2-e053-2a91aa0af5659

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-653-4668016065346130 g in 1 CAN (68016-653-46) 130 g2017-10-312028-06-30NoNoCurrent