Home NDC 85265-104 Soteri Skin Baby Eczema Relief Cream
Product NDC 85265-104
11-digit product format 852650104
Labeler code 85265
Product ID 85265-104_45a1740f-c49f-d3a0-e063-6294a90ab46b
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal
Dosage form EMULSION
Route TOPICAL
Labeler Soteri Skin, Inc
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-23
Substance OATMEAL
Active strength 2 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 Soteri Skin Baby Eczema Relief Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 2 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1189915 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 85265-104-01 Soteri Skin Baby Eczema Relief Cream 100 mL in 1 BOTTLE, PUMP EMULSION 100 2 85265-104-01 Soteri Skin Baby Eczema Relief Cream 1 in 1 CARTON EMULSION 1 2
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 30 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85265-104-01 85265010401 1 BOTTLE, PUMP in 1 CARTON (85265-104-01) / 100 mL in 1 BOTTLE, PUMP 2025-10-23 No No Current