FDA.reportPublic FDA data

NDC 0496-0834 - MiCort-HC

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
0496-0834
Package NDCs from labels
0496-0834-04
Manufacturer
Ferndale Laboratories, Inc.
Effective date
2008-01-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MICORT-HC LIPOCREAM 2% (Hydrocortisone acetate) Revised-November 2007Ferndale Laboratories, Inc.2008-01-24HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0496-0834-04MiCort-HC28.4 g in 1 TUBECREAM28.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0496-0834MICORT-HC (HYDROCORTISONE ACETATE) CREAM [FERNDALE LABORATORIES, INC.]11 package rows20080208_A08B5877-E83E-449F-865E-30FCFBDE665F.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74MICORT-HC (HYDROCORTISONE ACETATE) CREAM [FERNDALE LABORATORIES, INC.]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJMICORT-HC (HYDROCORTISONE ACETATE) CREAM [FERNDALE LABORATORIES, INC.]1
butylparabenINACTIVE INGREDIENT3QPI1U3FV8MICORT-HC (HYDROCORTISONE ACETATE) CREAM [FERNDALE LABORATORIES, INC.]1
ceteth 20INACTIVE INGREDIENTMICORT-HC (HYDROCORTISONE ACETATE) CREAM [FERNDALE LABORATORIES, INC.]1
cetostearyl alcoholINACTIVE INGREDIENTMICORT-HC (HYDROCORTISONE ACETATE) CREAM [FERNDALE LABORATORIES, INC.]1
citric acidINACTIVE INGREDIENT2968PHW8QPMICORT-HC (HYDROCORTISONE ACETATE) CREAM [FERNDALE LABORATORIES, INC.]1
light mineral oilINACTIVE INGREDIENTMICORT-HC (HYDROCORTISONE ACETATE) CREAM [FERNDALE LABORATORIES, INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHMICORT-HC (HYDROCORTISONE ACETATE) CREAM [FERNDALE LABORATORIES, INC.]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRMICORT-HC (HYDROCORTISONE ACETATE) CREAM [FERNDALE LABORATORIES, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RMICORT-HC (HYDROCORTISONE ACETATE) CREAM [FERNDALE LABORATORIES, INC.]1
white petrolatumINACTIVE INGREDIENT4T6H12BN9UMICORT-HC (HYDROCORTISONE ACETATE) CREAM [FERNDALE LABORATORIES, INC.]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 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
04DC1005-4051-59C3-0D39-A2B50453EECBA08B5877-E83E-449F-865E-30FCFBDE665F2008-01-24Adverse reactionsExact identifier
spl id: 04DC1005-4051-59C3-0D39-A2B50453EECB
spl set id: A08B5877-E83E-449F-865E-30FCFBDE665F

Reported adverse events (FAERS/openFDA)#

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