Home NDC 44577-623 KERA HC
Product NDC 44577-623
11-digit product format 445770623
Labeler code 44577
Product ID 44577-623_09d72089-c2ef-70f3-e063-6394a90a65ad
Type HUMAN OTC DRUG
Nonproprietary name HYDROCORTISONE
Dosage form CREAM
Route TOPICAL
Labeler Clinical Therapeutic Solutions
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-10-17
Substance HYDROCORTISONE
Active strength 1 g/100g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base KERA HC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106258 Internal RxNorm lookup 1314932 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44577-623-02 KERA HC 56 g in 1 TUBE CREAM 56 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44577-623 KERA HC (HYDROCORTISONE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS] 4 Current NDC, Legacy NDC, 1 package rows 20231111_ac215c8f-b224-480c-9295-3a34316293ba.zip
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 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44577-623-02 44577062302 56 g in 1 TUBE (44577-623-02) 56 g 2017-02-06 0000-00-00 No No Current