FDA.reportPublic FDA data

TERBINAFINE HCL 5%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:54

Label at a glance#

ProductTERBINAFINE HCL 5%
Active ingredientTERBINAFINE HYDROCHLORIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

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Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

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Active, inactive

COMPONENTS

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NDC 72934- 4175-9 TERBINAFINE HCL USP 5%. Solution 15 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TERBINAFINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix071052ABCDEFGH@14175-9 end.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-4175-92021-01-29C16284748780-1ba0f9c33-3ab6-a910-e053-dadaa90a0b85TERBINAFINE HCL 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-4175-9TERBINAFINE HCL 5%15 g in 1 VIALSOLUTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-4175TERBINAFINE HCL 5% SOLUTION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190521_8966ec7b-dd56-1a48-e053-2a95a90a13b4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-417572934-4175-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
TERBINAFINE HYDROCHLORIDE012C11ZU6GACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8966ec7b-dd57-1a48-e053-2a95a90a13b48966ec7b-dd56-1a48-e053-2a95a90a13b42019-05-21Adverse reactionsExact identifier
spl id: 8966ec7b-dd57-1a48-e053-2a95a90a13b4
spl set id: 8966ec7b-dd56-1a48-e053-2a95a90a13b4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.