FDA.reportPublic FDA data

Silka

Product NDC
50066-080
11-digit product format
500660080
Labeler code
50066
Product ID
50066-080_38f62b9e-4081-44e8-e063-6394a90a1f3a
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Genomma Lab USA, Inc.
Application
ANDA077511
Marketing category
ANDA
Marketing start
2007-07-02
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
1 g/100g
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077511-001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silka AntifungalTERBINAFINE HYDROCHLORIDEGenomma Lab USA, Inc.a32cf699-e63e-4bd3-a5af-9e1ba447e02e2025-07-02WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Do not use on nails or scalp in or near the mouth or eyes for vaginal yeast infections When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or gets worse. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Silka
Brand name suffix
Antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G
Rxcui992528, 1739221

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-080-02Silka Antifungal30 g in 1 TUBECREAM307
50066-080-02Silka Antifungal1 in 1 CARTONCREAM17
50066-080-03Silka Antifungal30 g in 1 TUBECREAM307
50066-080-03Silka Antifungal1 in 1 CARTONCREAM17
50066-080-05Silka Antifungal15 g in 1 TUBECREAM157
50066-080-05Silka Antifungal1 in 1 CARTONCREAM17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
TerbinafineACTIVE MOIETYG7RIW8S0XPSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ISILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RSILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-080SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]6Current NDC, Legacy NDC, 6 package rows20240412_a32cf699-e63e-4bd3-a5af-9e1ba447e02e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739221SILKA 1 % Topical CreamPSNa32cf699-e63e-4bd3-a5af-9e1ba447e02e7
992528terbinafine HCl 1 % Topical CreamPSNa32cf699-e63e-4bd3-a5af-9e1ba447e02e7
1739221terbinafine hydrochloride 10 MG/ML Topical Cream [Silka Cream]SBDa32cf699-e63e-4bd3-a5af-9e1ba447e02e7
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCDa32cf699-e63e-4bd3-a5af-9e1ba447e02e7
1739221Silka 1 % Topical CreamSYa32cf699-e63e-4bd3-a5af-9e1ba447e02e7
1739221Silka Cream 10 MG/ML Topical CreamSYa32cf699-e63e-4bd3-a5af-9e1ba447e02e7
992528terbinafine hydrochloride 1 % Topical CreamSYa32cf699-e63e-4bd3-a5af-9e1ba447e02e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50066-080-02500660080021 TUBE in 1 CARTON (50066-080-02) / 30 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
50066-080-03500660080031 TUBE in 1 CARTON (50066-080-03) / 30 g in 1 TUBE1 tube2018-05-210000-00-00NoNoCurrent
50066-080-05500660080051 TUBE in 1 CARTON (50066-080-05) / 15 g in 1 TUBE1 tube2018-12-200000-00-00NoNoCurrent