Home NDC 0394-0859 Hydrocortisone
Product NDC 0394-0859
11-digit product format 003940859
Labeler code 0394
Product ID 0394-0859_4d3f087b-6bc1-f6b1-e063-6394a90a9047
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form LOTION
Route TOPICAL
Labeler Mericon Industries
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-12
Substance HYDROCORTISONE
Active strength 1.14 g/114g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Hydrocortisone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 1.14 g/114g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 103403 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 0394-0859-32 Hydrocortisone 12 in 1 BOX LOTION 12 3 0394-0859-32 Hydrocortisone 114 g in 1 BOTTLE, DISPENSING LOTION 114 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0394-0859 HYDROCORTISONE LOTION [MERICON INDUSTRIES] 2 Current NDC, 2 package rows 20241228_8f351b04-8f6d-4353-9100-13a8a80d656a.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 Marketing start Sample Exclude flag Status 0394-0859-32 00394085932 12 BOTTLE, DISPENSING in 1 BOX (0394-0859-32) / 114 g in 1 BOTTLE, DISPENSING 2023-06-12 No No Current