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 12 of 15 · 296 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Micotrin ACCLOTRIMAZOLEPureTek Corporationcbe4dd18-c9ef-a4e4-e053-2995a90a52892024-10-01WarningsExact identifier
unii: G07GZ97H65
Mycozyl ACCLOTRIMAZOLEPureTek Corporationb676d257-3cfd-7f24-e053-2995a90a546e2024-10-01WarningsExact identifier
unii: G07GZ97H65
Clotrimazole 1%CLOTRIMAZOLEDabur India Limited22916978-303f-e62a-e063-6394a90a21002024-09-20WarningsExact identifier
unii: G07GZ97H65
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEA-S Medication Solutions4320f2b8-ac47-40f4-9275-e7c5506e30e42024-09-11Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEActavis Pharma, Inc.a6ac4020-2c67-426a-8289-7e54ce43d0c92024-08-27Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
Betamethasone valerateBETAMETHASONE VALERATEAlembic Pharmaceuticals Inc.3b6fa573-de04-4626-a39a-dca39def6df22024-08-23Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals, Inc.4add8f7b-48f0-6b6a-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Major ClotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.562dfc9f-1897-330a-e054-00144ff8d46c2024-08-14WarningsExact identifier
unii: G07GZ97H65
Publix Athletic FootCLOTRIMAZOLE 1%PUBLIX SUPER MARKETS, INC.d9f99680-5636-4136-a7c6-c3643339e6b42024-08-02WarningsExact identifier
unii: G07GZ97H65
Gentamicin SulfateGENTAMICIN SULFATEBausch & Lomb Incorporated41d01350-5c4b-42fc-be5f-986ceec02bd32024-07-22Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals, Inc.54241254-1d9a-346a-e054-00144ff8d46c2024-07-17WarningsExact identifier
unii: G07GZ97H65
Betamethasone ValerateBETAMETHASONE VALERATENuCare Pharmaceuticals,Inc.a2154b33-0f61-49af-e053-2995a90a18102024-06-20Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATENORTHSTAR RX LLC8d03b9ba-f7a8-4fbf-9be1-83d815c2be452024-06-20Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsb63a3fe5-5684-41bc-ad6c-69c54e5b942d2024-06-20WarningsExact identifier
unii: G07GZ97H65
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.82595309-304e-a221-e053-2991aa0ac0a92024-06-14Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GENTAMICIN SULFATEGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.85424b40-5c2d-421d-e053-2991aa0a77712024-06-14Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.627375fb-2f20-16bc-e053-2a91aa0a15422024-06-06WarningsExact identifier
unii: G07GZ97H65
BETAMETHASONE VALERATEBETAMETHASONE VALERATENuCare Pharmaceuticals,Inc.64badc1a-8922-c6e3-e053-2991aa0a8b1c2024-06-06Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATENuCare Pharmaceuticals,Inc.5cc511e4-3e7d-70d6-e053-2a91aa0a80442024-06-04Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLECardinal Health 110 dba LEADER199df107-3384-6e03-e063-6294a90afc382024-05-29WarningsExact identifier
unii: G07GZ97H65

Reported adverse events (FAERS/openFDA)#

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