Home NDC 51824-050 CAREALL Hydrocortisone
Product NDC 51824-050
11-digit product format 518240050
Labeler code 51824
Product ID 51824-050_d36efb97-adb6-41e5-a077-1ea4d711fb05
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler New World Imports, Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-03-11
Marketing end 2027-01-01
Substance HYDROCORTISONE ACETATE
Active strength 1 g/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
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 CAREALL Hydrocortisone
Brand name suffix Maximum Strength Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE ACETATE 1 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X7931PO74 Internal UNII 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 51824-050-01 CAREALL Hydrocortisone Maximum Strength 28 g in 1 TUBE CREAM 28 7 51824-050-09 CAREALL Hydrocortisone Maximum Strength .9 g in 1 PACKET CREAM .9 7 51824-050-14 CAREALL Hydrocortisone Maximum Strength 144 in 1 CONTAINER CREAM 144 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51824-050 CAREALL HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [NEW WORLD IMPORTS, INC] 7 Current NDC, Legacy NDC, 3 package rows 20241009_ea656cf8-cad5-4fa5-82e7-daec77a0bb04.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51824-050-01 51824005001 28 g in 1 TUBE (51824-050-01) 28 g 2016-04-27 2027-01-01 No No Current 51824-050-09 51824005009 .9 g in 1 PACKET (51824-050-09) 2016-04-27 0000-00-00 No No Current 51824-050-14 51824005014 144 PACKET in 1 CONTAINER (51824-050-14) / .9 g in 1 PACKET (51824-050-09) 144 packet 2022-05-01 2027-01-01 No No Current