Baby XtraCare Oatmeal

Product NDC
57337-070
11-digit product format
573370070
Labeler code
57337
Product ID
57337-070_2c6a4461-23ef-636b-e063-6294a90a1f2a
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
LOTION
Route
TOPICAL
Labeler
Rejoice International
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-16
Substance
DIMETHICONE
Active strength
1.2 g/100g
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
Baby XtraCare Oatmeal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE1.2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui876980

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-070-01Baby XtraCare Oatmeal227 g in 1 BOTTLELOTION2272
57337-070-02Baby XtraCare Oatmeal354 g in 1 BOTTLELOTION3542

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
AVENA SATIVA WHOLEINACTIVE INGREDIENT5P8D0Z74RGBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
POLYACRYLAMIDE (10000 MW)INACTIVE INGREDIENTE2KR9C9V2IBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RBABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-070BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]2Current NDC, Legacy NDC, 2 package rows20250125_0049462b-ff31-440f-9244-b61153625bca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876980dimethicone 1.2 % Topical LotionPSN0049462b-ff31-440f-9244-b61153625bca2
876980dimethicone 12 MG/ML Topical LotionSCD0049462b-ff31-440f-9244-b61153625bca2
876980dimethicone 1.2 % Topical LotionSY0049462b-ff31-440f-9244-b61153625bca2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57337-070-0157337007001227 g in 1 BOTTLE (57337-070-01) 227 g2025-01-01NoNoCurrent
57337-070-0257337007002354 g in 1 BOTTLE (57337-070-02) 354 g2025-01-01NoNoCurrent