Home NDC 84387-005 HYDROCORTISONE
Product NDC 84387-005
11-digit product format 843870005
Labeler code 84387
Product ID 84387-005_26bc238d-3bdb-0c29-e063-6394a90a35fb
Type HUMAN OTC DRUG
Nonproprietary name HYDROCORTISONE
Dosage form CREAM
Route TOPICAL
Labeler ALLIED TRADE LINK LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-12
Substance HYDROCORTISONE
Active strength 10 mg/g
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 HYDROCORTISONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 10 mg/g
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 106258 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 84387-005-01 HYDROCORTISONE 28.4 g in 1 TUBE CREAM 28.4 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84387-005 HYDROCORTISONE CREAM [ALLIED TRADE LINK LLC] 1 Current NDC, 1 package rows 20241115_26bc238d-3bda-0c29-e063-6394a90a35fb.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 Sample Exclude flag Status 84387-005-01 84387000501 28.4 g in 1 TUBE (84387-005-01) 28.4 g 2024-11-12 No No Current