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 5 of 40 · 800 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEALMUSZ ECZEMAHYDROCORTISONE 1% ECZEMAJiangxi Yudexi Pharmaceutical Co., LTD511e54e0-2abe-fb76-e063-6294a90ada682026-06-14WarningsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone 1% Anti-ItchCreamHYDROCORTISONEAcme United Corporation5425fc2b-4f25-3e64-e063-6394a90aff492026-06-13WarningsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Aldermed Inc.4a7b532e-b292-b595-e063-6394a90acc9c2026-06-12WarningsExact identifier
unii: WI4X0X7BPJ
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
good sense anti itchHYDROCORTISONEPreferred Pharmaceuticals Inc.e51047da-8e17-4dd7-be3c-54820a7485f22026-06-09WarningsExact identifier
unii: WI4X0X7BPJ
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
KetoconazoleKETOCONAZOLENuCare Pharmaceuticals, Inc.53492ad1-baca-a7f6-e063-6294a90a29902026-06-02Adverse reactionsExact identifier
unii: R9400W927I
Walgreens Scalp Itch ReliefHYDROCORTISONEWalgreens34952272-1f9e-c642-e063-6394a90ae2bd2026-05-29WarningsExact identifier
unii: WI4X0X7BPJ
ciprofloxacin hydrochloride and hydrocortisoneCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONESandoz Incc0881bbe-cc95-45d4-9878-3bc8946eff262026-05-29Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEMylan Pharmaceuticals Inc.bc751403-94f2-4f9d-b533-cf6186a40ceb2026-05-25Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEBryant Ranch Prepack04758c46-0ca4-4852-acdc-1f8553ce2e6e2026-05-21Adverse reactionsExact identifier
unii: WI4X0X7BPJ
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
KetoconazoleKETOCONAZOLEPreferred Pharmaceuticals Inc.d59df5bf-bfa6-45fa-81f6-8c8ee2f24cf82026-05-14Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLE CREAM, 2%Preferred Pharmaceuticals Inc.abc2446c-cdc2-48fe-80f2-cf0038d2a85e2026-05-14Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Scalpicin Anti-Itch Maximum StrengthHYDROCORTISONEReckitt Benckiser LLC7b1a29fa-b266-43e6-a87b-aa3c96ab40412026-05-13WarningsExact identifier
unii: WI4X0X7BPJ
DERMFREE Anti-itch CreamHYDROCORTISONE1% ANTI-ITCH CREAMJiangxi Zhongletang Pharmaceuticals Co.,Ltd.519c319a-9c43-0e63-e063-6394a90ab8692026-05-13WarningsExact identifier
unii: WI4X0X7BPJ
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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