xtracare skin relief oatmeal daily moisturizing

Generic: dimethicone

Labeler: rejoice international
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name xtracare skin relief oatmeal daily moisturizing
Generic Name dimethicone
Labeler rejoice international
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

dimethicone 5 mg/354mg

Manufacturer
Rejoice International

Identifiers & Regulatory

Product NDC 57337-037
Product ID 57337-037_102196fb-1c53-da2c-e063-6294a90a8c96
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2013-11-26

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57337037
Hyphenated Format 57337-037

Supplemental Identifiers

RxCUI
891710
UPC
0849607052964 0849607052957
UNII
92RU3N3Y1O
NUI
N0000010282

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xtracare skin relief oatmeal daily moisturizing (source: ndc)
Generic Name dimethicone (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/354mg
source: ndc
Packaging
  • 354 mg in 1 BOTTLE (57337-037-01)
  • 227 mg in 1 BOTTLE (57337-037-02)
source: ndc

Packages (2)

57337-037-01 354 mg in 1 BOTTLE (57337-037-01) 57337-037-02 227 mg in 1 BOTTLE (57337-037-02)

Ingredients (1)

dimethicone (5 mg/354mg)

Linked Drug Pages (1)

XtraCare Skin Relief Oatmeal Daily Moisturizing ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "102196fb-1c53-da2c-e063-6294a90a8c96", "openfda": {"nui": ["N0000010282"], "upc": ["0849607052964", "0849607052957"], "unii": ["92RU3N3Y1O"], "rxcui": ["891710"], "spl_set_id": ["8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Rejoice International"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "354 mg in 1 BOTTLE (57337-037-01)", "package_ndc": "57337-037-01", "marketing_start_date": "20131126"}, {"sample": false, "description": "227 mg in 1 BOTTLE (57337-037-02)", "package_ndc": "57337-037-02", "marketing_start_date": "20131126"}], "brand_name": "XtraCare Skin Relief Oatmeal Daily Moisturizing", "product_id": "57337-037_102196fb-1c53-da2c-e063-6294a90a8c96", "dosage_form": "LOTION", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "57337-037", "generic_name": "Dimethicone", "labeler_name": "Rejoice International", "product_type": "HUMAN OTC DRUG", "brand_name_base": "XtraCare Skin Relief Oatmeal Daily Moisturizing", "active_ingredients": [{"name": "DIMETHICONE", "strength": "5 mg/354mg"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20131126", "listing_expiration_date": "20261231"}