Home NDC 76162-601 Baby Eczema Therapy
Product NDC 76162-601
11-digit product format 761620601
Labeler code 76162
Product ID 76162-601_4ab99192-6816-4df6-e063-6294a90aa196
Type HUMAN OTC DRUG
Nonproprietary name Colloidal oatmeal
Dosage form CREAM
Route TOPICAL
Labeler Topco Associates LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-25
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 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 Baby Eczema Therapy
Listing expiration 2027-12-31 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76162-601-28 Baby Eczema Therapy 141 g in 1 TUBE CREAM 141 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-601 BABY ECZEMA THERAPY (COLLOIDAL OATMEAL) CREAM [TOPCO ASSOCIATES, LLC] 3 Current NDC, 1 package rows 20250311_4f6af42c-f41e-455f-b94b-3793bf0b9a3f.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 30 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 76162-601-28 76162060128 141 g in 1 TUBE (76162-601-28) 141 g 2024-04-25 No No Current