FDA.reportPublic FDA data

NDC 70677-1003-01 - Terbinafine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70677-1003
Requested NDC
70677-1003-01
Package NDCs from labels
70677-1003-1, 70677-1003-01
Manufacturer
STRATEGIC SOURCING SERVICES LLC | Sun Pharma Canada Inc.
Effective date
2025-07-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Terbinafine Hydrochloride CreamSTRATEGIC SOURCING SERVICES LLC | Sun Pharma Canada Inc.2025-07-21HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1003-1Terbinafine Hydrochloride30 g in 1 TUBECREAM302
70677-1003-1Terbinafine Hydrochloride1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1003TERBINAFINE HYDROCHLORIDE CREAM [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 2 package rows20230711_28a3ece3-78fb-4121-86a7-adc4a9d9540f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1003-1GM - Gram70677-1003a7005fed-1bc1-4563-b936-d23d3647d35012023-10-16

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 6 of 13 · 260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerbinafineTERBINAFINE HYDROCHLORIDEBryant Ranch Prepack838c6140-19b6-4c2b-aed7-3065bd67af072025-09-18Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
LAMISIL AT TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDEVoyant Beauty, Inc.1fd313ad-a3d9-6c86-e063-6394a90a7ae42025-09-17WarningsExact identifier
rxcui: 992528
unii: 012C11ZU6G
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
terbinafine hydrochlorideTERBINAFINE HYDROCHLORIDEProficient Rx LP53235270-6ffb-44c8-aa55-debf59e1d9642025-09-01Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
equate Athletes FootTERBINAFINE HYDROCHLORIDEWal-Mart Stores Ince799c808-7c0f-482d-99d2-35fc34dbb2ea2025-08-14WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Good Neighbor PharmacyTERBINAFINE HYDROCHLORIDEAmerisourceBergen93ea9e7f-6914-4df2-8ca0-27c4538066232025-07-28WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Athletes FootTERBINAFINE HYDROCHLORIDERite Aid Corporationa7b0a70b-a117-48cf-a6bc-260be1dac1e72025-07-28WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC28a3ece3-78fb-4121-86a7-adc4a9d9540f2025-07-21WarningsExact identifier
application number: ANDA077511
ndc (package): 70677-1003-1
ndc (product): 70677-1003
ndc11 (package): 70677100301
rxcui: 992528
spl id: 3a732374-1d6b-705c-e063-6394a90a1b15
spl set id: 28a3ece3-78fb-4121-86a7-adc4a9d9540f
unii: 012C11ZU6G
Athletes FootTERBINAFINE HYDROCHLORIDEH E B28db9a27-4d23-48ef-b1f3-08b993948c112025-07-15WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Kroger AntifungalTERBINAFINE HYDROCHLORIDEKroger Company32e79416-5de4-4f06-9fff-f8c36a1ad5db2025-07-15WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEWALGREEN COMPANY2ba1924b-9967-4adb-9061-d023ef44ab3e2025-07-10WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDECardinal Health, 110 dba LEADERa9412747-c7f9-4242-91ed-3695f372f6c92025-07-09WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Silka AntifungalTERBINAFINE HYDROCHLORIDEGenomma Lab USA, Inc.a32cf699-e63e-4bd3-a5af-9e1ba447e02e2025-07-02WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Silka Jock ItchTERBINAFINE HYDROCHLORIDEGenomma Lab USA, Inc.326d8586-042f-44f8-8530-e46b7b777bc32025-07-02WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G

Reported adverse events (FAERS/openFDA)#

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