Home NDC 55910-803 Baby Eczema Therapy
Product NDC 55910-803
11-digit product format 559100803
Labeler code 55910
Product ID 55910-803_4c0fc0fd-720d-30d1-e063-6394a90afb72
Type HUMAN OTC DRUG
Nonproprietary name Colloidal oatmeal
Dosage form CREAM
Route TOPICAL
Labeler Old East Main Co.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-04-11
Substance OATMEAL
Active strength 10.4 kg/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 10.4 kg/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 55910-803-28 Baby Eczema Therapy 141 g in 1 TUBE CREAM 141 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-803 BABY ECZEMA THERAPY (COLLOIDAL OATMEAL) CREAM [OLD EAST MAIN CO.] 17 Current NDC, Legacy NDC, 1 package rows 20241004_9720e2ad-1bcf-4023-8e92-22a962df3aad.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 66 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55910-803-28 55910080328 141 g in 1 TUBE (55910-803-28) 141 g 2016-04-11 0000-00-00 No No Current