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 13 of 16 · 301 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
FemmesilCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCefddad82-9dc7-4cd9-b33c-7e85f30d992e2024-05-24WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEQUALITY CHOICE (Chain Drug Marketing Association)3c676ff0-44a8-40cd-8f85-d39dda3d96372024-05-23WarningsExact identifier
unii: G07GZ97H65
Up and Up Athletes FootCLOTRIMAZOLE 1%Target Corporation52b61859-11ae-4990-aa0c-9dc1dd00adf42024-05-08WarningsExact identifier
unii: G07GZ97H65
Betamethasone ValerateBETAMETHASONE VALERATEPadagis Israel Pharmaceuticals Ltddc5dfd3e-7762-40c8-880e-c7db80d877492024-03-31Warnings, Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Clotrimazole AntifungalCLOTRIMAZOLETrifecta Pharmaceuticals USA, LLC.11bf50db-552e-0a39-e063-6394a90af60d2024-02-19WarningsExact identifier
unii: G07GZ97H65
GENTAMICINGENTAMICINHF Acquisition Co LLC, DBA HealthFirstc1ff0cdc-ac5d-30ca-e053-2a95a90a50662024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GENTAMICIN SULFATEGENTAMICIN SULFATEHF Acquisition Co LLC, DBA HealthFirste9fbe619-2afe-f1d7-e053-2a95a90aab292024-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Target Jock ItchCLOTRIMAZOLE 1%Target Corporationf44d4c44-99d1-413f-b9c3-8330bdd21abb2024-01-17WarningsExact identifier
unii: G07GZ97H65
Gentamicin SulfateGENTAMICIN SULFATEPadagis Israel Pharmaceuticals Ltda9486ae1-350b-41c5-ae0c-a4d692bb2dfd2024-01-15Adverse reactionsExact identifier
unii: 8X7386QRLV
gentamicin sulfateGENTAMICIN SULFATEDIRECT RX51a411a0-2671-4c1c-bf25-e29b32efed0c2024-01-10Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATESandoz Inca213fb9c-08ea-4f30-a6c9-93c7a9ba52802024-01-02Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
clotrimazoleCLOTRIMAZOLEProficient Rx LPeeb241a3-93ee-4b74-8cbb-65713d15e7e02024-01-01WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEProficient Rx LPba1dc4a4-073f-4f30-bb9c-9ed0437004312024-01-01WarningsExact identifier
unii: G07GZ97H65
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEProficient Rx LP7c64553b-589c-4e65-a6f0-b2847bbbe8a62024-01-01WarningsExact identifier
unii: G07GZ97H65
GentamicinGENTAMICINFresenius Kabi USA, LLC8bdeef7f-ad8e-46e0-a872-e945eae51d682023-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Betamethasone ValerateBETAMETHASONE VALERATEA-S Medication Solutionsf8711d17-de6a-45e3-8027-b650308207ed2023-12-15Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Betamethasone ValerateBETAMETHASONE VALERATEA-S Medication Solutionsd265d143-343f-41ec-9cb4-18d83edb772b2023-12-12Adverse reactionsExact identifier
unii: 9IFA5XM7R2

Reported adverse events (FAERS/openFDA)#

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