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 3 of 16 · 301 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories, Inc.2c60e631-5930-4420-886d-eb1990c720b62026-05-11WarningsExact identifier
unii: G07GZ97H65
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsc0f58a0d-a304-41f9-bbdf-c2e488230cf02026-05-11WarningsExact identifier
unii: G07GZ97H65
Gentamicin SulfateGENTAMICIN SULFATECardinal Health 107, LLC5113bfad-42ca-4bb8-9343-0b08c6cd03f02026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
ClotrimazoleCLOTRIMAZOLEAkron Pharma Inc692d7e0f-50d4-4abb-8c74-36bc98064fe72026-05-05WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEKJD Pharma Private Limited5115f8e3-5668-5207-e063-6394a90a76502026-05-05WarningsExact identifier
unii: G07GZ97H65
Gentamicin SulfateGENTAMICIN SULFATEPreferred Pharmaceuticals Inc.5ac8ea7a-ee89-49f5-8d30-6dbb56503d942026-05-05Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Clotrimazole Topical Solution USP, 1%CLOTRIMAZOLE TOPICAL SOLUTION USP, 1%ScieGen Pharmaceuticals, Inc15368c2a-572f-41fb-a3a1-7b1eb842faa82026-04-30Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
FifthPulse Clotrimazole AntifungalCLOTRIMAZOLEWeCare Products LLC9f5ea297-5a25-42cc-bd47-4159108b00232026-04-27WarningsExact identifier
unii: G07GZ97H65
SimplyVital Antifungal ClotrimazoleCLOTRIMAZOLEAlpha Plants Inc44881106-3ab4-4103-9c48-1da435ab5b132026-04-16WarningsExact identifier
unii: G07GZ97H65
Clotrimazole Topical Solution USP, 1%CLOTRIMAZOLE TOPICAL SOLUTION USP, 1%Allegis Holdings, LLC529bb597-b291-42fb-b45f-744a55df64f12026-04-09Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
RoyceDerm Tinea ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4e889f2b-9ea1-b1a6-e063-6394a90a46542026-04-03WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.70e1efac-1738-43db-b19c-bbe02810b6e72026-04-01WarningsExact identifier
unii: G07GZ97H65
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATESportpharm LLC313dde2e-fb82-4786-988b-565d3e003c372026-04-01Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEPreferred Pharmaceuticals Inc.caba588a-13df-4035-ac41-6b4ec90cd88d2026-04-01WarningsExact identifier
unii: G07GZ97H65
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEPreferred Pharmaceuticals Inc.196e24fc-3315-4366-ad40-51b7ea54b2112026-04-01Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.80d67df3-843d-47bb-85a2-d2f26a8243362026-03-31WarningsExact identifier
unii: G07GZ97H65
RoyceDerm Antifungal BarCLOTRIMAZOLERoyceDerm LLC3abdc4a8-58dd-5bd0-e063-6294a90a1bca2026-03-31WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals, Inc.624827d6-dbf8-4f3d-a8c0-c92474cad7de2026-03-31WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.fd010006-f646-46ed-841a-9f247b19e3972026-03-31WarningsExact identifier
unii: G07GZ97H65
Lasolex Liquid SolutionCLOTRIMAZOLE 1%PureTek Corporation4dc9e64d-8235-b218-e063-6394a90a01572026-03-24WarningsExact identifier
unii: G07GZ97H65

Reported adverse events (FAERS/openFDA)#

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