FDA.reportPublic FDA data

NDC 13985-701 - MotaZol

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
13985-701
Package NDCs from labels
13985-701-07, 13985-701-15, 13985-701-30, 13985-701-21
Manufacturer
MWI
Effective date
2024-11-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MotaZol - MWIMWI2024-11-15PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-701-07MotaZol7.5 g in 1 BOTTLE, DISPENSINGSUSPENSION7.57
13985-701-07MotaZol1 in 1 CARTONSUSPENSION17
13985-701-15MotaZol15 g in 1 BOTTLE, DISPENSINGSUSPENSION157
13985-701-15MotaZol1 in 1 CARTONSUSPENSION17
13985-701-21MotaZol215 g in 1 BOTTLE, PLASTICSUSPENSION2157
13985-701-21MotaZol1 in 1 CARTONSUSPENSION17
13985-701-30MotaZol1 in 1 CARTONSUSPENSION17
13985-701-30MotaZol30 g in 1 BOTTLE, DISPENSINGSUSPENSION307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-701MOTAZOL (GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE, AND CLOTRIMAZOLE) SUSPENSION [MWI]78 package rows20241116_e9e374b8-f483-4f63-b7bb-96352b7abae4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65MOTAZOL (GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE, AND CLOTRIMAZOLE) SUSPENSION [MWI]3
Gentamicin SulfateACTIVE INGREDIENT8X7386QRLVMOTAZOL (GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE, AND CLOTRIMAZOLE) SUSPENSION [MWI]3
Mometasone Furoate MonohydrateACTIVE INGREDIENTMTW0WEG809MOTAZOL (GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE, AND CLOTRIMAZOLE) SUSPENSION [MWI]3
ClotrimazoleACTIVE MOIETYG07GZ97H65MOTAZOL (GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE, AND CLOTRIMAZOLE) SUSPENSION [MWI]3
GentamicinACTIVE MOIETYT6Z9V48IKGMOTAZOL (GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE, AND CLOTRIMAZOLE) SUSPENSION [MWI]3
MometasoneACTIVE MOIETY8HR4QJ6DW8MOTAZOL (GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE, AND CLOTRIMAZOLE) SUSPENSION [MWI]3

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 15 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLEPadagis US LLC3f57ef51-8202-4d0b-95a8-d2df468b8d9a2022-05-31Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
Gentamicin SulfateGENTAMICIN SULFATEAsclemed USA, Inc.a54e5c95-609d-4d66-9573-5d1ac78fa58f2022-03-04Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Micomitin AntifungalCLOTRIMAZOLEPureTek Corporationdd05f5f9-2412-1295-e053-2995a90acb962022-02-14WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEProficient Rx LPc62264a9-cea3-4461-9399-35d8931d38d52022-02-01Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEHikma Pharmacuticals USA USA Inc.0bc4b876-ddee-4f03-b44f-544348739a262021-07-30Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LPcf4386ba-c62a-4ee8-ab59-1bb2e737a5da2021-05-01Adverse reactionsExact identifier
unii: 8X7386QRLV
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEProficient Rx LPc6e4bf5f-f6d6-489e-9286-c30568c601b72021-01-01Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEGlenmark Pharmaceuticals Inc. USA8dcd24cb-e568-428a-88ac-737d115cc54d2020-11-09Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLE TOPICALNovitium Pharma LLC02df90b9-4879-4e73-b03a-0e96f3d099ea2020-08-13Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
GentakGENTAMICIN SULFATEProficient Rx LPaebfe247-cdf7-4acb-97b3-6d4341d7c8152019-11-01Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LP2098faaa-7f60-4640-8c37-19456ebba6532019-11-01Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV

Reported adverse events (FAERS/openFDA)#

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