Home NDC 54473-410 Renew Intensive Skin Therapy
Product NDC 54473-410
11-digit product format 544730410
Labeler code 54473
Product ID 54473-410_42790fbf-5c8b-ad6b-e063-6294a90af297
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal
Dosage form CREAM
Route TOPICAL
Labeler Melaleuca Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
Substance OATMEAL
Active strength .5 g/50mL
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 Additional Listing Data#
Finished product Yes
Brand name base Renew Intensive Skin Therapy
Brand name suffix Targeted Eczema Treatment
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL .5 g/50mL
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 240651 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 54473-410-01 Renew Intensive Skin TherapyTargeted Eczema Treatment 50 mL in 1 TUBE, WITH APPLICATOR CREAM 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-410 RENEW INTENSIVE SKIN THERAPY TARGETED ECZEMA TREATMENT (COLLOIDAL OATMEAL) CREAM [MELALEUCA INC.] 2 Current NDC, 1 package rows 20240531_198c7caf-576b-1466-e063-6394a90afe25.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 54473-410-01 54473041001 50 mL in 1 TUBE, WITH APPLICATOR (54473-410-01) 50 ml 2024-01-01 No No Current