Home NDC 61328-112 ECZEMA DERMATITIS RELIEF BALM
Product NDC 61328-112
11-digit product format 613280112
Labeler code 61328
Product ID 61328-112_5b4ad054-9ed9-c5f3-e063-6294a90a0d33
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 5 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 DERMATITIS RELIEF BALM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 5 g/100g
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61328-112-20 ECZEMA DERMATITIS RELIEF BALM 50 g in 1 BOTTLE, PUMP CREAM 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61328-112 ECZEMA DERMATITIS RELIEF BALM (COLLOIDAL OATMEAL) CREAM [SKINFIX, INC.] 2 Current NDC, 1 package rows 20241228_fb801d20-9bec-1c71-e053-6394a90a6e95.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 39 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 61328-112-20 61328011220 50 g in 1 BOTTLE, PUMP (61328-112-20) 50 g 2023-10-01 No No Current 61328-112-30 61328011230 1 TUBE in 1 CARTON (61328-112-30) / 40 g in 1 TUBE 1 tube 2026-09-12 No No Current