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 3 of 14 · 264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
unii: LKG8494WBH
TERBINAFINE HYDROCHLORIDETERBINAFINE TABLETS 250 MGNuCare Pharmaceuticals,Inc.bf020c17-578f-74c4-e053-2995a90a9e7d2026-03-02Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.92b31fc4-0f02-4857-b11f-49b9f942ee842026-02-20WarningsExact identifier
application number: ANDA077511
ndc (package): 51672-2080-4
ndc (package): 51672-2080-1
ndc (package): 51672-2080-2
ndc (package): 51672-2080-3
ndc (package): 51672-2080-9
ndc (package): 51672-2080-6
ndc (package): 51672-2080-8
ndc (product): 51672-2080
ndc11 (package): 51672208001
rxcui: 992528
spl id: 4b425c57-bf63-6851-e063-6394a90ac6e7
spl set id: 92b31fc4-0f02-4857-b11f-49b9f942ee84
unii: 012C11ZU6G
TERBINAFINE HYDROCHLORIDETERBINAFINE TABLETS 250 MGAmici Pharma, Inc.dd8724e9-bef9-4258-b536-9c6d872c3bf82026-02-18Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
TerbinafineTERBINAFINE HYDROCHLORIDEREMEDYREPACK INC.44c6f6e7-e0c0-450e-83ce-1ed4f3efddec2026-02-13Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
PHARMBANNER TINEA VERSICOLOR CreamTINEA VERSICOLOR CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3db832f4-630d-72a2-e063-6394a90a08dc2026-02-12WarningsExact identifier
rxcui: 992528
unii: 012C11ZU6G
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDENorthwind Health Company, LLCab6f50a5-87ce-0819-e053-2a95a90a22b72026-01-01Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: LKG8494WBH
unii: 2KR89I4H1Y

Reported adverse events (FAERS/openFDA)#

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