FDA.reportPublic FDA data

XtraCare with cooling action Oatmeal Skin Relief Calmin

Product NDC
57337-055
Requested package NDC
57337-055-01
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
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
XtraCare with cooling action Oatmeal Skin Relief Calmin
Listing expiration
2026-12-31

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
29abd476-c32d-49f0-b283-30f4ba570ab4Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-055-012024-02-28C16284748780-11030e365-3070-111a-e063-dadaa90a10e2XtraCare with cooling action Oatmeal Skin Relief Calmin
57337-055-012024-01-30C16284748780-11030e365-3070-111a-e063-dadaa90a10e2XtraCare with cooling action Oatmeal Skin Relief Calmin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-055-01XtraCare with cooling action Oatmeal Skin Relief Calmin227 g in 1 BOTTLELOTION2273

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
OATINACTIVE INGREDIENTZ6J799EAJKXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWVXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-055XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_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 1 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891710dimethicone 1.3 % Topical LotionPSN29abd476-c32d-49f0-b283-30f4ba570ab43
891710dimethicone 13 MG/ML Topical LotionSCD29abd476-c32d-49f0-b283-30f4ba570ab43
891710dimethicone 1.3 % Topical LotionSY29abd476-c32d-49f0-b283-30f4ba570ab43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-055-0157337005501227 g in 1 BOTTLE (57337-055-01) 227 g2013-11-260000-00-00NoNoCurrent