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

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 4 of 52 · 1,022 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERYNTH MULTI-PURPOSE FUNCUSTOLNAFTATE 1% MULTI-PURPOSE FUNCUSJiangxi Yudexi Pharmaceutical Co., LTD4a6ea0c9-1495-8ede-e063-6294a90ad0932026-07-23WarningsExact identifier
application number: M005
HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUIDShanghai Honghui Chuang Intelligent Technology Co., Ltd55753a4a-a4d0-a183-e063-6394a90acf112026-07-22WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kit .liquid.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION5719942d-6b10-612e-e063-6294a90a4fe92026-07-21WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL CARE ESSENTIAL OilUNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OILJiangxi Yudexi Pharmaceutical Co., LTD4ff57d2d-5e74-a995-e063-6394a90a3f9a2026-07-21WarningsExact identifier
application number: M005
WERPEKA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4f7a8273-b7af-d532-e063-6394a90aa63a2026-07-21WarningsExact identifier
application number: M005
HTRCSW FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD523bc484-511c-b603-e063-6394a90a55ae2026-07-21WarningsExact identifier
application number: M005
DERMFREE ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD49ab5abb-d311-505d-e063-6294a90a56162026-07-21WarningsExact identifier
application number: M005
DERMFREE FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD49aba00d-9249-b403-e063-6394a90a787d2026-07-21WarningsExact identifier
application number: M005
SKAPEMED SKIN REPAIRTOLNAFTATE 1% SKIN REPAIRJiangxi Yudexi Pharmaceutical Co., LTD4a20c32e-0551-aead-e063-6394a90a2aa72026-07-21WarningsExact identifier
application number: M005
REINREUDE MULTI-PURPOSE TREATMENTTOLNAFTATE 1% MULTI-PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a380945-9235-783a-e063-6294a90a094d2026-07-21WarningsExact identifier
application number: M005
SERYNTH Multi-Purpose Nail SolutionTOLNAFTATE 1% MULTI-PURPOSE NAIL SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4a4af770-2bba-52a8-e063-6294a90ac2872026-07-21WarningsExact identifier
application number: M005
SERYNTH ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD4a4b304a-1acc-9185-e063-6394a90a11762026-07-21WarningsExact identifier
application number: M005
SERYNTH FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c6b7a-3c3e-1510-e063-6294a90a409a2026-07-21WarningsExact identifier
application number: M005
SERYNTH HELPS WITH FUNGAL NAILTOLNAFTATE 1% HELPS WITH FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c9ad1-e652-2b3b-e063-6394a90a29352026-07-21WarningsExact identifier
application number: M005
DERMFREE HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZJiangxi Yudexi Pharmaceutical Co., LTD4a4d9361-3633-59b2-e063-6294a90aa3ea2026-07-21WarningsExact identifier
application number: M005
OURUI ONE FUNGAL NAIL TREATMENTTOLNAFTATE 1% FUNGAL NAIL TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a473f03-f4cc-74ef-e063-6394a90ac7072026-07-20WarningsExact identifier
application number: M005
AVENASTER FUNGAL NAIL CARE DUO SET (NIGHT)UNDECYLENIC ACID 25% FUNGAL NAIL CARE DUO SET (NIGHT)Jiangxi Yudexi Pharmaceutical Co., LTD51eb8766-cc94-360d-e063-6294a90a69532026-07-20WarningsExact identifier
application number: M005
TINGOLE FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESJiangxi Yudexi Pharmaceutical Co., LTD5272c6fa-75f7-c698-e063-6394a90ac81e2026-07-20WarningsExact identifier
application number: M005
Vamy ANTIFUNGALTOLNAFTATE 1% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4dfdf3a2-95a8-9176-e063-6294a90a64de2026-07-20WarningsExact identifier
application number: M005
Antifungal creamANTIFUNGAL CREAMShenzhen Earth Surface Trading Co., Ltd.5708cc16-9a26-fd3c-e063-6394a90ac0ee2026-07-20WarningsExact 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