XtraCare Skin Relief Oatmeal Daily Moisturizing

Product NDC
57337-037
11-digit product format
573370037
Labeler code
57337
Product ID
57337-037_102196fb-1c53-da2c-e063-6294a90a8c96
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
5 mg/354mg
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 Skin Relief Oatmeal Daily Moisturizing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE5 mg/354mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891710Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d9e0893-c9be-4f5a-afc2-b5b997c8d1ccAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-037-01XtraCare Skin Relief Oatmeal Daily Moisturizing354 mg in 1 BOTTLELOTION3546
57337-037-02XtraCare Skin Relief Oatmeal Daily Moisturizing227 mg in 1 BOTTLELOTION2276

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
DIMETHICONEACTIVE MOIETY92RU3N3Y1OXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
LAURETH-7INACTIVE INGREDIENTZ95S6G8201XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
OATINACTIVE INGREDIENTZ6J799EAJKXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWVXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-037XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]6Current NDC, Legacy NDC, 2 package rows20240131_8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc.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 34 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ODLUMIVIE Salmon DNA Repairing SerumRH-OLIGOPEPTIDE-1ODLUMIVIE435ecb5b-0d12-4da1-e063-6394a90a8be22025-11-11WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMKROGER3feb1346-76b6-fbb6-e063-6394a90a17d12025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Ceramide ReviCell CreamCERAMIDE NPODLUMIVIE435ee48f-1b9e-6d08-e063-6394a90af5b52025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Dendrobium Restorative MaskDENDROBIUM OFFICINALE STEMODLUMIVIE435ef0e0-50be-c4e4-e063-6294a90a8e8e2025-11-11WarningsExact identifier
application number: M016
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
application number: M016
TATWAX VITAMINS ADPETROLATUMNantong Health & Beyond Hygienic Products Inc.333fdce4-5a1d-45a4-94fe-81d47ecd26702025-11-07WarningsExact identifier
application number: M016
Arme Scar GelDIMETHICONENanjing Ludejin Corporation Management Co., Ltd42e9a59a-480e-f74a-e063-6294a90a06402025-11-06WarningsExact identifier
application number: M016
Baby Diaper Rash CreamZINC OXIDEHello Bello42f14aa6-5694-7727-e063-6294a90a09f32025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Classic EssenceNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1e874ac0-a993-be9e-e063-6394a90af4242025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Eye CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eeb9c36-5bd8-ec90-e063-6294a90ae4e12025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair SerumNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eb08f86-eb2a-7f29-e063-6294a90a05162025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Moisturizing CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eec4cfe-d5a3-3570-e063-6294a90ac38b2025-11-06WarningsExact identifier
application number: M016
Spa Dry Heel Foot ReliefDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a92025-11-05WarningsExact identifier
application number: M016
Royal Jelly Berry Powerful Lip CareDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.09323fbe-76b5-48c6-80a7-c35b64110a7d2025-11-05WarningsExact identifier
application number: M016
Pink Eczema CreamCOLLOIDAL OATMEALMOOGOO SKIN CARE PTY LTD3b8d92d0-ab7f-8dd5-e063-6394a90aa3af2025-11-04WarningsExact identifier
application number: M016
MedlineZINC OXIDE, PETROLATUMMedline Industries, LPf162b1a8-65b3-13a8-e053-2a95a90a3f132025-11-04WarningsExact identifier
application number: M016
MedlinePETROLATUMMedline Industries, LPf3062b61-e4c4-9f57-e053-2995a90aa0282025-11-04WarningsExact identifier
application number: M016
Sandra Plasencia Dendrobium Officinale Soothing Biofermented MaskTITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.3cdf06f2-63f2-7a59-e063-6294a90a72ea2025-11-03WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELPremier Brands of America Inc.38583c02-497b-922c-e063-6294a90a49de2025-11-03WarningsExact identifier
application number: M016
The Zoeun Omega SerumCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4277da80-b55b-74af-e063-6394a90af3252025-10-31WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891710dimethicone 1.3 % Topical LotionPSN8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc6
891710dimethicone 13 MG/ML Topical LotionSCD8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc6
891710dimethicone 1.3 % Topical LotionSY8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-037-0157337003701354 mg in 1 BOTTLE (57337-037-01) 354 mg2013-11-260000-00-00NoNoCurrent
57337-037-0257337003702227 mg in 1 BOTTLE (57337-037-02) 227 mg2013-11-260000-00-00NoNoCurrent