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 9 of 13 · 260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TERBINAFINETERBINAFINEChartwell RX, LLC8ea693ec-e2f2-4661-b144-17651018e9fb2024-11-07Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: LKG8494WBH
unii: 2KR89I4H1Y
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
terbinafine hydrochlorideTERBINAFINE HYDROCHLORIDEA-S Medication Solutions8f6d7b1a-5a01-4cc5-b5b7-c126ae8895572024-10-14Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
unii: LKG8494WBH
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
unii: LKG8494WBH
TerbinafineTERBINAFINE HYDROCHLORIDEProficient Rx LP0a54cc4f-0789-46ce-875f-df759aa95d9c2024-09-01Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEBryant Ranch Prepack17e976c6-ee44-42c5-987f-5360ee6d7c1e2024-08-29Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.5d01fde5-e4cf-6670-e053-2991aa0a5b152024-07-15Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
unii: LKG8494WBH
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
TerbinafineTERBINAFINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.87af930f-493c-590e-e053-2a95a90a804a2024-06-14Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.715cae3e-4e86-48b3-e053-2a95a90afdc22024-06-10Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TerbinafineTERBINAFINE HYDROCHLORIDEBryant Ranch Prepack294bc1af-50e3-4bff-8d48-321e673033ce2024-05-30Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G

Reported adverse events (FAERS/openFDA)#

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