Home NDC 72609-704 ECZEMA
Product NDC 72609-704
11-digit product format 726090704
Labeler code 72609
Product ID 72609-704_45c89ca7-3354-d315-e063-6394a90ac647
Type HUMAN OTC DRUG
Nonproprietary name COLLOIDAL OATMEAL
Dosage form CREAM
Route TOPICAL
Labeler Smith Amish, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-28
Substance OATMEAL
Active strength 1.25 g/100g
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 ECZEMA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 1.25 g/100g
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72609-704-04 ECZEMA 113 g in 1 JAR CREAM 113 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72609-704 ECZEMA (COLLOIDAL OATMEAL) CREAM [SMITH AMISH, LLC] 2 Current NDC, 1 package rows 20241115_20c4bc16-ba20-47ec-e063-6394a90a8b4e.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 30 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72609-704-04 72609070404 113 g in 1 JAR (72609-704-04) 113 g 2025-08-01 No No Current