Home NDC 57337-055 XtraCare with cooling action Oatmeal Skin Relief Calmin
Product NDC 57337-055
11-digit product format 573370055
Labeler code 57337
Product ID 57337-055_126e086f-ebd9-cffb-e063-6294a90afdc5
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone
Dosage form LOTION
Route TOPICAL
Labeler Rejoice International
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-11-26
Substance DIMETHICONE
Active strength 3 g/227g
Pharmacologic classes Skin Barrier Activity [PE]
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 XtraCare with cooling action Oatmeal Skin Relief Calmin
Listing expiration 2027-12-31 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57337-055-01 XtraCare with cooling action Oatmeal Skin Relief Calmin 227 g in 1 BOTTLE LOTION 227 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-055 XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL] 3 Current NDC, Legacy NDC, 1 package rows 20240229_29abd476-c32d-49f0-b283-30f4ba570ab4.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 39 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 Marketing end Sample Exclude flag Status 57337-055-01 57337005501 227 g in 1 BOTTLE (57337-055-01) 227 g 2013-11-26 0000-00-00 No No Current