Home NDC 85477-316 Hydralyn
Product NDC 85477-316
11-digit product format 854770316
Labeler code 85477
Product ID 85477-316_01324071-1cc1-4031-bdd1-f93eb28e678a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydralyn
Dosage form GEL
Route TOPICAL
Labeler Oncora Pharma, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-07-28
Substance HYDROCORTISONE
Active strength 2 g/100g
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 Hydralyn
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 2 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 604449 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85477-316-28 85477031628 28 g in 1 TUBE (85477-316-28) 28 g 2025-07-28 No No Current