Home NDC 71570-001 Atopis Eczema Therapy Cream
Product NDC 71570-001
11-digit product format 715700001
Labeler code 71570
Product ID 71570-001_2919c17e-5f02-d32a-e063-6294a90abacb
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal
Dosage form CREAM
Route TOPICAL
Labeler Bionona Limited
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-15
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 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 Atopis Eczema Therapy Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL .5 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 1654149 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71570-001-01 Atopis Eczema Therapy Cream 75 g in 1 BOTTLE CREAM 75 2 71570-001-01 Atopis Eczema Therapy Cream 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71570-001 ATOPIS ECZEMA THERAPY CREAM (COLLOIDAL OATMEAL) CREAM [BIONONA LIMITED] 2 Current NDC, Legacy NDC, 2 package rows 20241215_8d4b4a14-b631-f2fa-e053-2a95a90a932f.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 45 of 68 · 1,343 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71570-001-01 71570000101 1 BOTTLE in 1 CARTON (71570-001-01) / 75 g in 1 BOTTLE 1 bottle 2019-07-15 0000-00-00 No No Current