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 18 of 40 · 799 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONENEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEAmneal Pharmaceuticals NY LLCbea0457d-40a7-4af9-ac77-b042356801762025-10-06Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HYDROCORTISONEHYDROCORTISONEBryant Ranch Prepackdc220e63-f9b2-47ea-b8ed-940902a130bf2025-10-03Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONESun Pharmaceutical Industries, Inc.e4f22e9c-cf38-473a-8f7d-8da7fd696f762025-10-02Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Viaderma Calm Anti-ItchHYDROCORTISONEViaDerma Distribution, Inc.7afa2ccd-bfc6-48fc-9a14-a0c6d645844e2025-10-01WarningsExact identifier
unii: WI4X0X7BPJ
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
LEADER HYDROCORTISONE WITH ALOEHYDROCORTISONELEADER39916470-15bf-4bd0-96e2-b909d68cf9c42025-09-29WarningsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone 1%HYDROCORTISONEChain Drug Marketing Association Inc.3d48a3c6-b7d6-6794-e063-6294a90afff92025-09-29WarningsExact identifier
unii: WI4X0X7BPJ
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Xpect HydrocortisoneHYDROCORTISONECintas Corporation45ef9be4-54c4-4d85-966b-27708313ded42025-09-26WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEWalgreens Company0b4053a8-6c1c-621d-e063-6394a90a4f562025-09-25WarningsExact identifier
unii: WI4X0X7BPJ
Unishield 1%HYDROCORTISONEUnishield4871a67f-fbb8-4a6b-ace4-d343490289082025-09-24WarningsExact identifier
unii: WI4X0X7BPJ
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack0d85f349-2dc7-44a5-b5bd-83ac78d44d1d2025-09-24Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Meijer Hydrocortsione CreamHYDROCORTSIONE CREAM 1%Meijer Distribution Inc.1cbddb7e-f2e3-0951-e063-6394a90a3d372025-09-12WarningsExact identifier
unii: WI4X0X7BPJ
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: 6DC9Q167V3
HYDROCORTISONEHYDROCORTISONEMajor Pharmaceuticals91885fc8-876f-4a4d-8ae5-eb246a3358082025-09-10Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONE 1%Encube Ethicals, Inc.d6f5c0df-6262-4704-bb24-430f66bb2ca82025-09-09WarningsExact identifier
unii: WI4X0X7BPJ
KetoconazoleKETOCONAZOLE CREAM, 2%Encube Ethicals, Inc.59188ef7-5bc9-4acc-bbff-8712c41e5f772025-09-09Warnings, Adverse reactionsExact identifier
unii: R9400W927I
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation282ed5ef-8c2a-4092-9d99-1a7eee7a39e32025-09-09WarningsExact identifier
unii: WI4X0X7BPJ
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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