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 10 of 13 · 260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerbinafineTERBINAFINE HYDROCHLORIDEA-S Medication Solutions79a39fb1-12b7-4b1e-9f28-102af34d04592024-05-23Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
unii: LKG8494WBH
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
unii: LKG8494WBH
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
TerbinafineTERBINAFINE HYDROCHLORIDEAurobindo Pharma Limited6600e2b3-65df-4fc3-8081-d574537d27e32024-04-18Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
TerbinafineTERBINAFINE HYDROCHLORIDENorthStar Rx LLC8f87e3e1-4c9c-497a-af20-8ab52cfeef602024-04-18Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
TerbinafineTERBINAFINE HYDROCHLORIDEProficient Rx LP50657431-1cd9-42dd-9cfc-57db8713d2672024-04-01Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEBryant Ranch Prepacke2ecf7a5-1c84-4977-8a87-d1bfb96586682024-02-07Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.c3832113-f517-4b4e-bf9c-31fce1a638e12023-12-22Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G

Reported adverse events (FAERS/openFDA)#

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