Home NDC 83636-115 The Zoeun Omega Serum
Product NDC 83636-115
11-digit product format 836360115
Labeler code 83636
Product ID 83636-115_4277da80-b55c-74af-e063-6394a90af325
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal
Dosage form GEL
Route TOPICAL
Labeler Sturgeonbio Co.,Ltd.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-01
Substance OATMEAL
Active strength .007 g/100mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
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 The Zoeun Omega Serum
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL .007 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8PI54V663Y 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 83636-115-01 The Zoeun Omega Serum 50 mL in 1 BOTTLE, PUMP GEL 50 1
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 44 of 68 · 1,350 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83636-115-01 83636011501 50 mL in 1 BOTTLE, PUMP (83636-115-01) 50 ml 2025-10-01 No No Current