Home NDC 57337-100 Oatmeal Skin Relief Calming .
Product NDC 57337-100
11-digit product format 573370100
Labeler code 57337
Product ID 57337-100_8384b028-7b9c-2a7b-e053-2a91aa0a342c
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone
Dosage form LOTION
Route TOPICAL
Labeler Rejoice International Inc.
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2019-03-07
Substance DIMETHICONE
Active strength 3 g/227g
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Oatmeal Skin Relief Calming .
Brand name suffix 8oz
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 3 g/227g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 891710 Internal RxNorm 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 57337-100-01 Oatmeal Skin Relief Calming .8oz 227 g in 1 BOTTLE LOTION 227 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-100 OATMEAL SKIN RELIEF CALMING . 8OZ (DIMETHICONE) LOTION [REJOICE INTERNATIONAL INC.] 1 Current NDC, Legacy NDC, 1 package rows 20190308_8384dc52-ba36-da3d-e053-2a91aa0a4f40.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 Marketing end Sample Exclude flag Status 57337-100-01 57337010001 227 g in 1 BOTTLE (57337-100-01) 227 g 2019-03-07 0000-00-00 No No Current