Home NDC 85529-204 MediBalm
Product NDC 85529-204
11-digit product format 855290204
Labeler code 85529
Product ID 85529-204_387b74cf-5783-b70c-e063-6294a90a7248
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form OINTMENT
Route TOPICAL
Labeler BalmRx, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-21
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 MediBalm
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 203105 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 85529-204-01 MediBalm 7 g in 1 JAR OINTMENT 7 3 85529-204-01 MediBalm 1 in 1 BOX OINTMENT 1 3
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 85529-204-01 85529020401 1 JAR in 1 BOX (85529-204-01) / 7 g in 1 JAR 1 jar 2025-04-21 No No Current