FDA.reportPublic FDA data

NDC 70782-143 - Oticetic Flush, Medicated

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
70782-143
Package NDCs from labels
70782-143-08
Manufacturer
GlenHaven LLC
Effective date
2023-06-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oticetic Flush, Medicated - GlenHaven LLCGlenHaven LLC2023-06-08OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70782-143-08Oticetic Flush, Medicated236 mL in 1 BOTTLESOLUTION2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70782-143OTICETIC FLUSH, MEDICATED (HYDROCORTISONE AND KETOCONAZOLE) SOLUTION [GLENHAVEN LLC]11 package rows20230610_afbf58da-5683-40f1-bb5c-5cb8bfd8251a.zip

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 28 of 28 · 555 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LP601cab21-c211-4c34-be7b-f4fdd97a921a2022-05-02Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
KetoconazoleKETOCONAZOLEProficient Rx LP4f08caf2-a57c-4146-9289-532711bbdbcd2022-04-01Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLETeva Pharmaceuticals USA, Inc.7fc47a6a-3714-4598-ae3b-d5a229262c212021-09-02Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONESandoz Inc96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d2021-08-31Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONESandoz Inc.99d9030f-9118-412c-a377-d1df1c8fa7232021-08-31Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEAsclemed USA, Inc.b8437441-a4a6-4fb5-82eb-e49af69704f42021-04-10Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEProficient Rx LPd55f1783-9c49-4f90-9ff8-6f132e7b325e2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEAsclemed USA, Inc.7c78ec84-8b7c-42f1-a879-3bf27a1daa712020-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
XereseACYCLOVIR AND HYDROCORTISONEBausch Health US LLC3b6ac164-0f1e-4f36-94a1-1fdb07d710f52020-08-03Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEActavis Pharma, Inc.aa9dba84-eb38-4ec3-8555-87c948bf23842020-07-01Adverse reactionsExact identifier
unii: WI4X0X7BPJ
KetoconazoleKETOCONAZOLE FOAMXiromed, LLCea319889-5e58-f778-3009-5ba6a5f2690a2019-09-23Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Aloe CortHYDROCORTISONETopiderm, Inc.789a6669-3320-4558-8d6f-ab255db50d8d2019-09-17WarningsExact identifier
unii: WI4X0X7BPJ
Discount Drug Mart Anti-itchHYDROCORTISONEDISCOUNT DRUG MART, INC.853eee29-6f57-59d4-e053-2991aa0aa6112019-03-29WarningsExact identifier
unii: WI4X0X7BPJ
Cortisol PhenolicHYDROCORTISONEEnergique, Inc.43d65eee-f4c3-4a6a-a3bb-cfa6d672bc472018-09-13WarningsExact identifier
unii: WI4X0X7BPJ
Intensive Healing EczemaHYDROCORTISONEWalgreens3d27f041-c554-4139-87b5-709537785f222018-02-04WarningsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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