FDA.reportPublic FDA data

NDC 54925-032 - TRI OTIC

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
54925-032
Package NDCs from labels
54925-032-75, 54925-032-15, 54925-032-10, 54925-032-45, 54925-032-25, 54925-032-40
Manufacturer
Med-Pharmex, Inc
Effective date
2023-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TRI OTIC - Med-Pharmex, IncMed-Pharmex, Inc2023-07-14PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE VALERATEACTIVE INGREDIENT9IFA5XM7R2TRI OTIC (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE ) OINTMENT [MED-PHARMEX, INC]2
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65TRI OTIC (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE ) OINTMENT [MED-PHARMEX, INC]2
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVTRI OTIC (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE ) OINTMENT [MED-PHARMEX, INC]2
BETAMETHASONEACTIVE MOIETY9842X06Q6MTRI OTIC (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE ) OINTMENT [MED-PHARMEX, INC]2
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65TRI OTIC (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE ) OINTMENT [MED-PHARMEX, INC]2
GENTAMICINACTIVE MOIETYT6Z9V48IKGTRI OTIC (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE ) OINTMENT [MED-PHARMEX, INC]2

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 14 of 16 · 301 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AKIN ANTI-FUNGALCLOTRIMAZOLESouthern Sales & Service, Inc.7836127f-d472-4aac-9443-10f56d735d1f2023-11-29WarningsExact identifier
unii: G07GZ97H65
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.16474069-510b-0754-9d78-9bc0354f65492023-11-23Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.9e550dc9-509e-da05-8a97-ecbd0f5dd6332023-11-22Adverse reactionsExact identifier
unii: 8X7386QRLV
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb4c4240f-f84c-ec5e-e053-2a95a90aa0822023-11-17WarningsExact identifier
unii: G07GZ97H65
SIMPLY VITAL Antifungal CreamCLOTRIMAZOLEALPHA PLANTS INCd3842de3-0d13-4dc2-920b-90a4b822bbb82023-11-11WarningsExact identifier
unii: G07GZ97H65
GentamicinGENTAMICIN SULFATEMedical Purchasing Solutions, LLC09cf88af-59da-f147-e063-6294a90aac992023-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Smooth Gator Fungus EliminatorCLOTRIMAZOLESmooth Gator, LLC262b04f5-1b5d-4c67-a557-01f8b17113022023-11-10WarningsExact identifier
unii: G07GZ97H65
Terrasil Jock Itch Treatment Maximum StrengthCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCc62fbf23-5d19-44ab-9c1a-e9b803192ed02023-11-08WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEProficient Rx LP800a9dab-d287-427e-af6d-26996e0def412023-11-01WarningsExact identifier
unii: G07GZ97H65
GentamicinGENTAMICIN SULFATEFresenius Kabi USA, LLC0cce2238-28d3-4280-b520-ffc3067a2ffa2023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
JOCK-EZECLOTRIMAZOLEBentlin Products LLCd3ff5bfb-2e0f-4daa-84b3-4a3016ca92802023-10-30WarningsExact identifier
unii: G07GZ97H65
TheraPlus PlusCLOTRIMAZOLEZhejiang Jingwei Pharmaceutical Co., Ltd.de75179d-1889-4823-9f39-4bebdf185d762023-10-27WarningsExact identifier
unii: G07GZ97H65
Thera plus Antifungal ClotrimazoleCLOTRIMAZOLEFOURSTAR GROUP USA, INC.1265be99-8922-4b76-bd63-19bfb42c38962023-10-26WarningsExact identifier
unii: G07GZ97H65
GentamicinGENTAMICINFresenius Kabi USA, LLCbe5b414e-d598-4721-80ee-5836156ad2102023-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GentamicinGENTAMICIN SULFATEFresenius Kabi USA, LLCa73a5453-c091-43fd-aae2-d992152363b12023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEA-S Medication Solutions5ca32ede-b546-4b65-90d6-c69add7605222023-09-28Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
GentamicinGENTAMICINHikma Pharmaceuticals USA Inc.51fffac8-fb6e-4f7f-b2de-440252781a422023-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEA-S Medication Solutionsb3f69dc2-2b88-4866-baea-aa3b3ed84fb12023-05-16Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
Betamethasone ValerateBETAMETHASONE VALERATE FOAMXiromed, LLC.dee8f6d1-b0ba-3c56-f08d-eb6283b0b2502023-05-08Warnings, Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Gentamicin SulfateGENTAMICIN SULFATEA-S Medication Solutions76fabcd6-4da3-49e3-85a1-ca4fac55a2072023-05-08Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV

Reported adverse events (FAERS/openFDA)#

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