FDA.reportPublic FDA data

NDC 51672-2080-03 - 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
51672-2080-03
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, 51672-2080-03
Manufacturer
Preferred Pharmaceuticals, Inc
Effective date
2026-09-30
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, Inc2026-09-30HUMAN 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 1 of 14 · 267 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TERBINAFINETERBINAFINE HYDROCHLORIDE TABLETAmerisyn LLC584d1fae-0120-49a0-e063-6394a90a36fc2026-08-05Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
terbinafine hydrochlorideTERBINAFINE HYDROCHLORIDEREMEDYREPACK INC.2886b2ff-815f-4621-bc28-1fea082c19202026-07-09Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Athlete Foot Treatment KitTERBINAFINE HYDROCHLORIDE, TOLNAFTATEBeautivity LLC3b3aa69f-4e73-cabc-e063-6294a90ab65b2026-06-29WarningsExact identifier
rxcui: 992528
Athlete Foot CreamTERBINAFINE HYDROCHLORIDEBeautivity LLC3b2c1d7f-32c3-aa3b-e063-6394a90a62672026-06-29WarningsExact identifier
rxcui: 992528
unii: 012C11ZU6G

Reported adverse events (FAERS/openFDA)#

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