Premier Solutions Antifungal Tolnaftate Liquid

Product NDC
56104-247
11-digit product format
561040247
Labeler code
56104
Product ID
56104-247_42b87b97-8d46-64ec-e063-6294a90a6b87
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Premier Brands of America, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-16
Substance
TOLNAFTATE
Active strength
.15 g/150g
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
Premier Solutions Antifungal Tolnaftate Liquid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE.15 g/150g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e1971c1c-5687-577b-e053-2a95a90ad95fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-247-01Premier Solutions Antifungal Tolnaftate Liquid150 g in 1 CANAEROSOL, SPRAY1505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-247PREMIER SOLUTIONS ANTIFUNGAL TOLNAFTATE LIQUID (TOLNAFTATE) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA, INC.]4Current NDC, Legacy NDC, 1 package rows20241016_e1971c1c-5687-577b-e053-2a95a90ad95f.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 41 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1236-CS Antifungal Powder (Talc Free)1236-CCANTIFUNGAL POWDER(TALC FREE)Dynarex Corporation312ba573-4008-83e6-e063-6294a90a4a6d2025-03-25WarningsExact identifier
application number: M005
Antifungal Medicated BarTOLNAFTATERoyceDerm LLC31305ed2-a0a0-6d4c-e063-6294a90a6ba52025-03-25WarningsExact identifier
application number: M005
Forticept Antimicrobial Hydrogel Wound DressingBENZETHONIUM CHLORIDE, THYMOLLidan, Inccd5b7a72-1b87-434d-973e-071d2c8a438c2025-03-25WarningsExact identifier
application number: M005
Forticept HP Antiseptic Wound CleanserBENZALKONIUM CHLORIDE, ALLANTOINLidan, inc.41bb46ee-edce-4e1b-bcfd-5c5729e1eb152025-03-25WarningsExact identifier
application number: M005
Forticept Antifungal Foot GelCLOTRIMAZOLELidan, Inc.1b5851fc-ae73-4e54-bb62-3ff928628b972025-03-25WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.14d2a661-a490-41ca-b84f-f2be3bc271b42025-03-24WarningsExact identifier
application number: M005
Dermatin AntifungalCLOTRIMAZOLEMelaleuca, Inc.e993fa3b-1d85-46b7-bda5-ed875be74c4e2025-03-20WarningsExact identifier
application number: M005
1% ketoconazoleKETOCONAZOLETAGRID LLC30b75584-3a1e-c125-e063-6294a90acaa72025-03-19WarningsExact identifier
application number: M005
Forticept Antifungal Foot CreamCLOTRIMAZOLELidan, Inc.17abeb4d-b211-4b8c-a9d2-4c7baba2450c2025-03-07WarningsExact identifier
application number: M005
Terramed Just Think Comfort Antifungal Medicated Body WipesTOLNAFTATERida LLC34577389-8e5d-49ab-a208-9c87b6f3cec42025-03-06WarningsExact identifier
application number: M005
Athletes FootMICONAZOLE NITRATERida LLC85e98ef8-75c3-4be1-b59f-40b5312e21372025-03-06WarningsExact identifier
application number: M005
SOUTH BEACH MULTI-PURPOSE NAIL REPAIRUNDECYLENIC ACIDSOUTH BEACH HAIR CARE PROFESIONAL INC2fb0110c-b275-2a17-e063-6394a90a2d302025-03-06WarningsExact identifier
application number: M005
DG Health Athletes FootCLOTRIMAZOLEDolgencorp, Inc.20370b32-21ad-4362-9b46-c6149c9072312025-02-28WarningsExact identifier
application number: M005
Family Wellness Clotrimazole 1 Anti Fungal CreamCLOTRIMAZOLEFamily Dollar Stores, Inc0667dd81-5633-494e-857e-45fa276fe72c2025-02-25WarningsExact identifier
application number: M005
Family Wellness Athletes Foot Tolnaftate 1 CreamTOLNAFTATEFamily Dollar Stores, Incf72b5bcd-8834-4da9-aa74-78992ec2838f2025-02-25WarningsExact identifier
application number: M005
ANTIFUNGAL MEDICATED BODY WASHTOLNAFTATERida LLCe3ebce6f-88ca-4100-ac79-d300f44e48912025-02-25WarningsExact identifier
application number: M005
FUNGINIX AFTOLNAFTATEThe Sisquoc Healthcare Corporationf6cf5315-6678-486c-85b2-d4b3f748600e2025-02-25WarningsExact identifier
application number: M005
FUNGINIX JOCK ITCH TREATMENTTOLNAFTATEThe Sisquoc Healthcare Corporationb2ce1c25-93d5-441f-9b3b-68ae46400c2c2025-02-25WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutionsbf131f33-3ab2-4f43-add5-920e78ac36a72025-02-24WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.0052992a-819c-4c55-bd88-201a09a3573a2025-02-21WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-247-0156104024701150 g in 1 CAN (56104-247-01) 150 g2022-06-160000-00-00NoNoCurrent