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 4 of 13 · 260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerbinafineTERBINAFINE HYDROCHLORIDEA-S Medication Solutions5de4c245-7086-453b-b90a-7a1242ec2c0b2025-12-18Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Lamisil ATTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.21f1bf77-4338-4b75-b513-80a0d98a722a2025-12-12WarningsExact identifier
unii: 012C11ZU6G
Lamisil ATTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.d3e75665-e2d4-47d9-baaa-93817b5fbf002025-12-12WarningsExact identifier
unii: 012C11ZU6G
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH
Walgreens Athletes FootTERBINAFINE HYDROCHLORIDEWalgreen Companyd706c56f-0123-4a5a-8c85-240cbe6ef7a52025-11-26WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
unii: LKG8494WBH
CVSTERBINAFINE HYDROCHLORIDECVS Pharmacy17684ba2-3c2c-4259-84fa-3833f19e5a4d2025-11-25WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEGolden State Medical Supply, Inc.b43e4644-024c-4aa6-b403-19152c7858022025-11-25Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Lamisil AT CreamTERBINAFINE HYDROCHLORIDEVoyant Beauty Inc.9dea4789-bf1c-1577-e053-2a95a90a53812025-11-18WarningsExact identifier
rxcui: 992528
unii: 012C11ZU6G
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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