Home NDC 82800-100 Prequel Barrier Therapy Rich Skin Protectant Cream
Product NDC 82800-100
11-digit product format 828000100
Labeler code 82800
Product ID 82800-100_45dc65a2-f662-f062-e063-6294a90a813f
Type HUMAN OTC DRUG
Nonproprietary name Skin Protectant Cream
Dosage form CREAM
Route TOPICAL
Labeler The Center Brands, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-10
Substance OATMEAL
Active strength 1 mg/g
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 Prequel Barrier Therapy Rich Skin Protectant Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 1 mg/g
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 82800-100-01 Prequel Barrier Therapy Rich Skin Protectant Cream 296 g in 1 TUBE CREAM 296 3 82800-100-01 Prequel Barrier Therapy Rich Skin Protectant Cream 1 in 1 PACKAGE CREAM 1 3
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 28 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 82800-100-01 82800010001 1 TUBE in 1 PACKAGE (82800-100-01) / 296 g in 1 TUBE 1 tube 2025-07-10 No No Current