FDA.reportPublic FDA data

NDC 51672-2080-01 - 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
51672-2080
Requested NDC
51672-2080-01
Package NDCs from labels
51672-2080-1, 51672-2080-2, 51672-2080-8, 51672-2080-9, 51672-2080-6, 51672-2080-3, 51672-2080-4, 51672-2080-01
Manufacturer
Preferred Pharmaceuticals, Inc
Effective date
2026-10-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Terbinafine Hydrochloride - Preferred Pharmaceuticals, IncPreferred Pharmaceuticals, Inc2026-10-09HUMAN OTC DRUG LABEL
Terbinafine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2026-09-11HUMAN OTC DRUG LABEL
Terbinafine Hydrochloride Cream 1% Antifungal CreamSun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2026-02-20HUMAN OTC DRUG LABEL
Terbinafine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2023-12-09HUMAN OTC DRUG LABEL
Terbinafine Hydrochloride - Proficient Rx LPProficient Rx LP2022-07-01HUMAN OTC DRUG LABEL
Terbinafine Hydrochloride Cream 1% Antifungal CreamREMEDYREPACK INC.2021-03-31HUMAN OTC DRUG LABEL
Terbinafine Hydrochloride Cream 1% Antifungal CreamPhysicians Total Care, Inc.2014-02-24HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2080-1Terbinafine Hydrochloride15 g in 1 TUBECREAM156
51672-2080-1Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-2Terbinafine Hydrochloride30 g in 1 TUBECREAM306
51672-2080-2Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-3Terbinafine Hydrochloride60 g in 1 TUBECREAM606
51672-2080-3Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-4Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-4Terbinafine Hydrochloride15 g in 1 TUBECREAM156
51672-2080-6Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-6Terbinafine Hydrochloride45 g in 1 TUBECREAM456
51672-2080-8Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-8Terbinafine Hydrochloride12 g in 1 TUBECREAM126
51672-2080-9Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-9Terbinafine Hydrochloride24 g in 1 TUBECREAM246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2080TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 14 package rows20210304_92b31fc4-0f02-4857-b11f-49b9f942ee84.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2080-1GM - Gram51672-20805b077eb2-4a3e-4467-b213-af80bebdfea212012-07-24
51672-2080-2GM - Gram51672-2080b99b56d3-5b68-429b-b864-d7cef0ee297012012-07-24
51672-2080-8GM - Gram51672-2080250969be-c2ab-423f-9beb-f2c9d68abc0512012-07-24
51672-2080-9GM - Gram51672-2080b03e439e-fc3f-496d-b719-b958636880ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1

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 14 · 264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
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

Reported adverse events (FAERS/openFDA)#

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