XtraCare Skin Relief Oatmeal Daily Moisturizing

Product NDC
57337-054
11-digit product format
573370054
Labeler code
57337
Product ID
57337-054_126dde68-9fa5-3cac-e063-6394a90aec7e
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 Skin Relief Oatmeal Daily Moisturizing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE3 g/227g

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
5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-054-012024-02-28C16284748780-11030e364-fa52-111a-e063-dadaa90a10e2XtraCare Skin Relief Oatmeal Daily Moisturizing
57337-054-012024-01-30C16284748780-11030e364-fa52-111a-e063-dadaa90a10e2XtraCare Skin Relief Oatmeal Daily Moisturizing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-054-01XtraCare Skin Relief Oatmeal Daily Moisturizing227 g in 1 BOTTLELOTION2273

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
OATINACTIVE INGREDIENTZ6J799EAJKXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWVXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-054XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907.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 4 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Jelly, Lil Drug StorePETROLATUM JELLYLil' Drug Store Products, Inc.5862af40-97e2-d792-e063-6394a90a0f1a2026-08-06WarningsExact identifier
application number: M016
AOAO RAPID ACNE RELIEFSALICYLIC ACID,BENZOYL PEROXIDEGuangzhou Senmai Biotechnology Co.,Ltd.586df874-0f71-ed46-e063-6294a90a0a8e2026-08-06WarningsExact identifier
application number: M016
Dealmed Vitamins A and DWHITE PETROLATUMDealmed Medical Supplies, LLC.d6584809-b438-4b2c-ab37-522e0dbef4702026-08-05WarningsExact identifier
application number: M016
Dealmed Vitamins A and DPETROLATUMDealmed Medical Supplies, LLC.84afe4ae-f9e8-406f-9fbe-f413975f86eb2026-08-05WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f52026-08-04WarningsExact identifier
application number: M016
Nail Treatment Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-08-03WarningsExact identifier
application number: M016
PROCUREZINC OXIDETWIN MED, LLCe68ae97e-668e-31c2-e053-2995a90ab4d32026-08-03WarningsExact identifier
application number: M016
PROCURE VITAMIN A AND D Skin ProtectantPETROLATUMTWIN MED, LLCbbbca68e-1b65-49b1-a5fa-ed4da55d05e32026-08-03WarningsExact identifier
application number: M016
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
application number: M016
456 Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.5830fd36-0613-1980-e063-6294a90adfb72026-08-03WarningsExact identifier
application number: M016
Crogooe Skin Relief CreamCOLLOIDAL OATMEALGuangdong Outeli Biotechnology Co., Ltd.57f9b3e8-25d3-2b20-e063-6394a90aaea52026-08-01WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.57c3556a-aad3-3e65-e063-6394a90ab6892026-07-29WarningsExact identifier
application number: M016
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
application number: M016
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
application number: M016
ATTITUDE Baby Leaves Diaper cream - UnscentedZINC OXIDE9055-7588 Quebec Inc. (Attitude)579aa481-f8ec-b263-e063-6394a90a77542026-07-27WarningsExact identifier
application number: M016
Boo Boo Magic Diaper Rash CreamyZINC OXIDEAlboo Brands LLC5114aff8-adde-e610-e063-6294a90a77ea2026-07-27WarningsExact identifier
application number: M016
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
application number: M016
Hello Bello Diaper Rash CreamZINC OXIDETopiderm, Inc.e158ba31-e159-4624-a490-fe70baaf4a392026-07-24WarningsExact identifier
application number: M016
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891710dimethicone 1.3 % Topical LotionPSN5ae6d5d4-caff-4360-a0e7-7c8d7a9b59073
891710dimethicone 13 MG/ML Topical LotionSCD5ae6d5d4-caff-4360-a0e7-7c8d7a9b59073
891710dimethicone 1.3 % Topical LotionSY5ae6d5d4-caff-4360-a0e7-7c8d7a9b59073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-054-0157337005401227 g in 1 BOTTLE (57337-054-01) 227 g2013-11-260000-00-00NoNoCurrent