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 8 of 40 · 800 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Ketoconazole CreamKETOCONAZOLE CREAMDirect_Rxf422aaa8-3cce-5989-e053-2a95a90a52052026-03-17Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Hydrocortisone CreamHYDROCORTISONE CREAMDirect_Rx364af43e-c1a9-3f03-e063-6294a90a14f52026-03-17Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEMericon Industries8f351b04-8f6d-4353-9100-13a8a80d656a2026-03-17WarningsExact identifier
unii: WI4X0X7BPJ
Crane Safety HydrocortisoneHYDROCORTISONECrane Safety LLC96d9527d-9bf7-ce82-e053-2995a90aff0c2026-03-16WarningsExact identifier
unii: WI4X0X7BPJ
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4cd62cba-075a-7448-e063-6394a90ab48d2026-03-12WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEStrides Pharma Science Limited90a46849-5b75-467b-9bc5-8f192d4d20d22026-03-11Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Anti-FungalANTI-FUNGAL SHAMPOOShenzhen Mengyue Technology Co., Ltd.4ca9a661-fa39-ab7f-e063-6294a90aed142026-03-10WarningsExact identifier
unii: R9400W927I
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
HYDROCORTISONEHYDROCORTISONEDIRECT RX3d017594-3a00-40ba-b392-1699992fa1b12026-03-05Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone CreamHYDROCORTISONE CREAMDirect_Rx19b09776-165a-9579-e063-6294a90a9d392026-03-05Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llcf4d4a56b-b4b7-9a07-e053-2a95a90ad8532026-03-04WarningsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llc9987165c-1a0f-dd57-e053-2a95a90ae7352026-03-04WarningsExact identifier
unii: WI4X0X7BPJ
HYDROCORTISONEHYDROCORTISONE 1%PHARMACY CHOICE INC4cdfe8b6-c332-7bf8-e063-6394a90abaec2026-03-03WarningsExact identifier
unii: WI4X0X7BPJ
CortenemaHYDROCORTISONEANI Pharmaceuticals, Inc.a307448a-ccc4-41a8-977a-11f28f0bded92026-03-02Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Procto-Med HCHYDROCORTISONENuCare Pharmaceuticals,Inc.4b972547-5bd4-155d-e063-6394a90a03ee2026-03-02Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEANI Pharmaceuticals, Inc.40654d12-56e4-4489-be49-19c60ad918ad2026-03-02Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEPD-Rx Pharmaceuticals, Inc.931ed426-89a1-4877-a4a5-cb963d51e7172026-02-25Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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