Home NDC 68786-001 SionBiotext Hydrocortisone
Product NDC 68786-001
11-digit product format 687860001
Labeler code 68786
Product ID 68786-001_35074279-3e3d-2a74-e063-6294a90af26f
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone Acetate 1%
Dosage form CREAM
Route TOPICAL
Labeler Sion Biotext Medical Ltd
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-13
Substance HYDROCORTISONE ACETATE
Active strength .1 g/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 SionBiotext Hydrocortisone
Listing expiration 2026-12-31 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 68786-001-28 SionBiotext Hydrocortisone 28.3 g in 1 BOX CREAM 28.3 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68786-001 SIONBIOTEXT HYDROCORTISONE (HYDROCORTISONE ACETATE 1%) CREAM [SION BIOTEXT MEDICAL LTD] 1 Current NDC, 1 package rows 20250515_35073eae-26fe-2bb5-e063-6294a90ab56a.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 Sample Exclude flag Status 68786-001-28 68786000128 28.3 g in 1 BOX (68786-001-28) 28.3 g 2025-05-13 No No Current