Home NDC 61328-010 ECZEMA HAND RELIEF
Product NDC 61328-010
11-digit product format 613280010
Labeler code 61328
Product ID 61328-010_483370fe-3400-2af0-e063-6294a90ab6d1
Type HUMAN OTC DRUG
Nonproprietary name COLLOIDAL OATMEAL
Dosage form CREAM
Route TOPICAL
Labeler Skinfix, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-01
Substance OATMEAL
Active strength 1 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 2027-12-31
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 HAND RELIEF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 1 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240651 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 61328-010-00 ECZEMA HAND RELIEF 90 g in 1 TUBE CREAM 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61328-010 ECZEMA HAND RELIEF (COLLOIDAL OATMEAL) CREAM [SKINFIX, INC.] 2 Current NDC, 1 package rows 20241228_0389bab7-04fb-7cfc-e063-6394a90a22d8.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 55 of 68 · 1,357 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 61328-010-00 61328001000 90 g in 1 TUBE (61328-010-00) 90 g 2023-10-01 No No Current