57337-037 NDC - XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE)

Drug Information

Product NDC: 57337-037

Proprietary Name: XtraCare Skin Relief Oatmeal Daily Moisturizing

Non Proprietary Name: Dimethicone

Active Ingredient(s):
  • 5 mg/354mg DIMETHICONE


Administration Route(s): TOPICAL

Dosage Form(s): LOTION

Pharmacy Class(es):
  • Skin Barrier Activity [PE]

Labeler Information

Labeler Name: Rejoice International
Product Type: HUMAN OTC DRUG
FDA Application Number: part347
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:11/26/2013

Package Information

No. Package Code Package Description Billing Unit
157337-037-01354 mg in 1 BOTTLE (57337-037-01)
257337-037-02227 mg in 1 BOTTLE (57337-037-02)

NDC Record

Field Name Field Value Definition
PRODUCT NDC57337-037The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEXtraCare Skin Relief Oatmeal Daily MoisturizingThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEDimethiconeThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELOTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE11/26/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERpart347This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMERejoice InternationalName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDIMETHICONEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH5 
ACTIVE INGRED UNITmg/354mg 
PHARM CLASSESSkin Barrier Activity [PE] 

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This page was last updated on: 2/1/2023