Home NDC 73105-003 GLADSKIN ECZEMACT ECZEMA
Product NDC 73105-003
11-digit product format 731050003
Labeler code 73105
Product ID 73105-003_4ba8734b-a8bf-515e-e063-6394a90a892d
Type HUMAN OTC DRUG
Nonproprietary name COLLOIDAL OATMEAL
Dosage form CREAM
Route TOPICAL
Labeler Micreos North America, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-05
Substance OATMEAL
Active strength .2 mg/mL
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 GLADSKIN ECZEMACT ECZEMA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL .2 mg/mL
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 2267204 Internal RxNorm 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 73105-003-00 GLADSKIN ECZEMACT ECZEMA 100 mL in 1 BOTTLE, PUMP CREAM 100 2 73105-003-00 GLADSKIN ECZEMACT ECZEMA 1 in 1 CARTON CREAM 1 2 73105-003-50 GLADSKIN ECZEMACT ECZEMA 1 in 1 CARTON CREAM 1 2 73105-003-50 GLADSKIN ECZEMACT ECZEMA 50 mL in 1 BOTTLE, PUMP CREAM 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73105-003 GLADSKIN ECZEMACT ECZEMA (COLLOIDAL OATMEAL) CREAM [MICREOS NORTH AMERICA, INC.] 1 Current NDC, 4 package rows 20231007_06f9af75-c5ff-d37b-e063-6394a90a4f6c.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 28 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 73105-003-00 73105000300 1 BOTTLE, PUMP in 1 CARTON (73105-003-00) / 100 mL in 1 BOTTLE, PUMP 2023-10-05 No No Current 73105-003-50 73105000350 1 BOTTLE, PUMP in 1 CARTON (73105-003-50) / 50 mL in 1 BOTTLE, PUMP 2023-10-05 No No Current