XtraCare with cooling action Oatmeal Skin Relief Calmin

Product NDC
57337-038
11-digit product format
573370038
Labeler code
57337
Product ID
57337-038_2dc099cd-a08d-d907-e063-6394a90a2929
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
2026-12-31
Current FDA listing
Yes

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
DIMETHICONE5 mg/354mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui891710

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-038-01XtraCare with cooling action Oatmeal Skin Relief Calmin354 mg in 1 BOTTLELOTION3547
57337-038-02XtraCare with cooling action Oatmeal Skin Relief Calmin227 mg in 1 BOTTLELOTION2277

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
DIMETHICONEACTIVE MOIETY92RU3N3Y1OXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
LAURETH-7INACTIVE INGREDIENTZ95S6G8201XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
MENTHOLINACTIVE INGREDIENTL7T10EIP3AXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
OATINACTIVE INGREDIENTZ6J799EAJKXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWVXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-038XTRACARE WITH COOLING ACTION OATMEAL SKIN RELIEF CALMIN (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]7Current NDC, Legacy NDC, 2 package rows20250212_f99606f6-83bc-436e-aa21-53e77eb87b9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891710dimethicone 1.3 % Topical LotionPSNf99606f6-83bc-436e-aa21-53e77eb87b9c7
891710dimethicone 13 MG/ML Topical LotionSCDf99606f6-83bc-436e-aa21-53e77eb87b9c7
891710dimethicone 1.3 % Topical LotionSYf99606f6-83bc-436e-aa21-53e77eb87b9c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-038-0157337003801354 mg in 1 BOTTLE (57337-038-01) 354 mg2013-11-260000-00-00NoNoCurrent
57337-038-0257337003802227 mg in 1 BOTTLE (57337-038-02) 227 mg2013-11-260000-00-00NoNoCurrent