"54473-410-01" National Drug Code (NDC)

NDC Code	54473-410-01
Package Description	50 mL in 1 TUBE, WITH APPLICATOR (54473-410-01)
Product NDC	54473-410
Product Type Name	HUMAN OTC DRUG
Proprietary Name	Renew Intensive Skin Therapy
Proprietary Name Suffix	Targeted Eczema Treatment
Non-Proprietary Name	Colloidal Oatmeal
Dosage Form	CREAM
Usage	TOPICAL
Start Marketing Date	20240101
Marketing Category Name	OTC MONOGRAPH DRUG
Application Number	505G(a)(3)
Manufacturer	Melaleuca Inc.
Substance Name	OATMEAL
Strength	.5
Strength Unit	g/50mL
Pharmacy 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]