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 6 of 40 · 800 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals Inc.02ab1006-c7c8-42c9-bda8-62c9d71425212026-05-11Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals, Inc.058bb2ff-ff51-4a3b-ba47-cb02272d06312026-05-11Adverse reactionsExact identifier
unii: WI4X0X7BPJ
hydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals Inc.12cd35e3-e707-4551-b778-bf615c1a8d322026-05-11WarningsExact identifier
unii: WI4X0X7BPJ
HYDROCORTISONEHYDROCORTISONEPreferred Pharmaceuticals Inc.0bbb8a63-ae1d-41d7-b201-d1b171b31f462026-05-11Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals, Inc.026728d4-846b-4bd4-9183-ae6c4a7141382026-05-11Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Harris Teeter HydrocortisoneHYDROCORTISONEHARRIS TEETER LLC4e8199f8-96ec-5342-e063-6294a90afb2d2026-05-07WarningsExact identifier
unii: WI4X0X7BPJ
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.5114cdba-96a1-c399-e063-6294a90aac122026-05-06WarningsExact identifier
unii: WI4X0X7BPJ
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd2dc7f76f-f9ad-46ba-8b41-952e1c15f0522026-04-29WarningsExact identifier
unii: WI4X0X7BPJ
anti itchHYDROCORTISONEHyVee Ince1db3641-2e83-4fec-8394-98d0d876ce0d2026-04-29WarningsExact identifier
unii: WI4X0X7BPJ
FixMySkin Healing Balm Vanilla FlavorHYDROCORTISONELovely Skin, Inc.52f7a561-a0b5-4562-a588-d74fd874b83a2026-04-28WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONESportpharm LLCef9cf62a-5805-48bc-915e-c0e91a10837e2026-04-24Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONESportpharm LLC78f43570-b6fd-42eb-bb9e-580abf79bf0d2026-04-24Adverse reactionsExact identifier
unii: WI4X0X7BPJ
FixMySkin Healing Balm UnflavoredHYDROCORTISONELovely Skin, Inc.9ff8db07-ad6d-4865-a534-94bd8312957e2026-04-23WarningsExact identifier
unii: WI4X0X7BPJ
DCH Labs CortisoneHYDROCORTISONE 1%Derma Care Research Labs5025f53a-02e0-0f6a-e063-6394a90adbbf2026-04-23WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEBryant Ranch Prepackc3916e9f-f783-45a2-b38b-959b12c262522026-04-22Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone 1%HYDROCORTISONEPreferred Pharmaceuticals Inc.e0f46445-64c5-4f5d-90b0-3fa07ed7d1b42026-04-22WarningsExact identifier
unii: WI4X0X7BPJ
HydravexHYDRAVEXOncora Pharma, LLC1da8a263-354a-4ab1-90b4-cc2ecba7c2f62026-04-22Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Alkindi SprinkleHYDROCORTISONEEton Pharmaceuticals, Inc.26c13a5f-7119-4c6a-bf10-fda4e07d76822026-04-21Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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