Home NDC 85884-261 Barrier Repair
Product NDC 85884-261
11-digit product format 858840261
Labeler code 85884
Product ID 85884-261_49ac2d2c-42bc-bdaf-e063-6294a90a6ac4
Type HUMAN OTC DRUG
Nonproprietary name Cream
Dosage form CREAM
Route TOPICAL
Labeler Steel City Health Private Limited
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-23
Substance OATMEAL; DIMETHICONE 350
Active strength .0025; .03 g/g; g/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 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 Barrier Repair
Brand name suffix Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL .0025 g/g DIMETHICONE 350 .03 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8PI54V663Y Internal UNII lookup 2Y53S6ATLU Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85884-261-03 Barrier RepairCream 100 g in 1 JAR CREAM 100 2 85884-261-04 Barrier RepairCream 1 in 1 JAR CREAM 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 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 85884-261-03 85884026103 100 g in 1 JAR 100 g Historical 85884-261-04 85884026104 1 JAR in 1 JAR (85884-261-04) / 100 g in 1 JAR (85884-261-03) 1 jar 2026-01-23 No No Current