Home NDC 54136-183 Calming Itch and Irritation
Product NDC 54136-183
11-digit product format 541360183
Labeler code 54136
Product ID 54136-183_45132ba3-8160-c77a-e063-6294a90a0868
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal
Dosage form LOTION
Route TOPICAL
Labeler Better Planet Brands LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-31
Substance OATMEAL
Active strength 2 g/100g
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 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 Calming Itch and Irritation
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 2 g/100g
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 1591951 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 54136-183-24 Calming Itch and Irritation 239 g in 1 TUBE LOTION 239 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54136-183 CALMING ITCH AND IRRITATION (COLLOIDAL OATMEAL) LOTION [BETTER PLANET BRANDS LLC] 3 Current NDC, 1 package rows 20250130_1dd7e712-56a4-86c0-e063-6294a90a75cd.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 38 of 68 · 1,357 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 54136-183-24 54136018324 239 g in 1 TUBE (54136-183-24) 239 g 2024-07-31 No No Current