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 32 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Liquid Antifungal TreatmentTOLNAFTATEHudson Health LLC14a9efd8-e49f-12fa-e063-6394a90aa8a02025-10-24WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEHudson Health LLC36ec5f05-5d1c-25df-e063-6394a90a9dd92025-10-24WarningsExact identifier
application number: M005
Signature Care Antifungal Cream Tolnaftate 1%TOLNAFTATEBETTER LIVING BRANDS LLCb02b81d6-8db4-927b-e053-2995a90a39582025-10-24WarningsExact identifier
application number: M005
Winco Foods TolnaftateTOLNAFTATEWinco Foods, LLC218f7613-1401-4f1b-bf46-576b536825af2025-10-23WarningsExact identifier
application number: M005
zourunan MULTI-PURPOS TREATMENTMULTI-PURPOS TREATMENTGuchutang Biotechnology (Longyan) Co., Ltd41bad254-b674-9521-e063-6294a90ab6342025-10-22WarningsExact identifier
application number: M005
zourunan FOOT ODOR PROBIOTICFOOT ODORGuchutang Biotechnology (Longyan) Co., Ltd41bbc02c-53f2-2d94-e063-6394a90ac9ec2025-10-22WarningsExact identifier
application number: M005
Signature Care Athletes FootCLOTRIMAZOLESafewayc1750c17-4afb-aecf-e053-2a95a90af35b2025-10-22WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATEImperial Feet B.V.1189c7d8-7c8f-ae01-e063-6294a90ac2702025-10-21WarningsExact identifier
application number: M005
Fungicure Liquid GelCLOTRIMAZOLEKobayashi Healthcare International, Inc.dfd03852-29bd-4e16-97f3-64dfde5f8ff82025-10-21WarningsExact identifier
application number: M005
Athlete Foot Medicated barTOLNAFTATEBeautivity LLC3b2cedb2-18f4-f571-e063-6394a90a64182025-10-21WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATEQuantum, Inc.6cb95707-9831-41f1-a23e-9e3356141fdc2025-10-20WarningsExact identifier
application number: M005
Toe FungusTOLNAFTATEImperial Feet B.V.118a6c97-4e8a-050a-e063-6294a90a11082025-10-17WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALTOLNAFTATEGuangzhou Haishi Biological Technology Co., Ltd.4141574d-7a5b-c437-e063-6394a90aacb62025-10-16WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYHY-VEE, INC415ecf9b-460d-82b6-e063-6294a90a0e052025-10-16WarningsExact identifier
application number: M005
SEACALL NAIL REVIVE SERUMNAIL REVIVE SERUMGuangdong Quadrant Ecological Technology Co., Ltd.1f4d0c9a-361e-72e5-e063-6394a90a7cda2025-10-15WarningsExact identifier
application number: M005
Arflom Toenail Fungus Treatment LiquidTOENAIL FUNGUS TREATMENT LIQUIDGuangzhou Qiexiran Cosmetics Co., Ltd.413e76b5-263c-62fa-e063-6294a90a92142025-10-15WarningsExact identifier
application number: M005
VTROUY Fungus Nail RenewalFUNGUS NAIL RENEWALGuangzhou Qiexiran Cosmetics Co., Ltd.413f6399-dda1-8dd9-e063-6394a90a573d2025-10-15WarningsExact identifier
application number: M005
Hongo KillerTOLNAFTATEEfficient Laboratories Inc8c9c958a-2371-4ce5-948e-625c26cdaacb2025-10-14WarningsExact identifier
application number: M005
Hongo KillerTOLNAFTATEEfficient Laboratories Inc83c592b4-4b17-4fe1-91ec-778c949e61962025-10-14WarningsExact identifier
application number: M005
Hongo KillerTOLNAFTATEEfficient Laboratories Inc173b4c79-ff51-4358-b843-cf24190231732025-10-14WarningsExact 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