FDA.reportPublic FDA data

NDC 86002-103 - KC Oto-Pack

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
86002-103
Package NDCs from labels
86002-103-02
Manufacturer
DermaZoo, LLC
Effective date
2015-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
KC Oto-Pack - DermaZoo, LLCDermaZoo, LLC2015-03-20PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86002-103-02KC Oto-Pack54 mL in 1 CONTAINERGEL541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86002-103KC OTO-PACK (HYDROCORTISONE, KETOCONAZOLE) GEL [DERMAZOO, LLC]11 package rows20150321_9c0c5b19-a6fb-434e-a319-eba1d9b04cf1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJKC OTO-PACK (HYDROCORTISONE, KETOCONAZOLE) GEL [DERMAZOO, LLC]1
KETOCONAZOLEACTIVE INGREDIENTR9400W927IKC OTO-PACK (HYDROCORTISONE, KETOCONAZOLE) GEL [DERMAZOO, LLC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJKC OTO-PACK (HYDROCORTISONE, KETOCONAZOLE) GEL [DERMAZOO, LLC]1
KETOCONAZOLEACTIVE MOIETYR9400W927IKC OTO-PACK (HYDROCORTISONE, KETOCONAZOLE) GEL [DERMAZOO, LLC]1
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38SKC OTO-PACK (HYDROCORTISONE, KETOCONAZOLE) GEL [DERMAZOO, LLC]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBKC OTO-PACK (HYDROCORTISONE, KETOCONAZOLE) GEL [DERMAZOO, LLC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2KC OTO-PACK (HYDROCORTISONE, KETOCONAZOLE) GEL [DERMAZOO, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3KC OTO-PACK (HYDROCORTISONE, KETOCONAZOLE) GEL [DERMAZOO, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RKC OTO-PACK (HYDROCORTISONE, KETOCONAZOLE) GEL [DERMAZOO, LLC]1

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 40 of 40 · 799 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
HydrocortisoneHYDROCORTISONEAsclemed USA, Inc.b8437441-a4a6-4fb5-82eb-e49af69704f42021-04-10Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Cortisol PhenolicHYDROCORTISONEEnergique, Inc.43d65eee-f4c3-4a6a-a3bb-cfa6d672bc472018-09-13WarningsExact identifier
unii: WI4X0X7BPJ
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Intensive Healing EczemaHYDROCORTISONEWalgreens3d27f041-c554-4139-87b5-709537785f222018-02-04WarningsExact identifier
unii: WI4X0X7BPJ
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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