xtracare with cooling action oatmeal skin relief calmin

Generic: dimethicone

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

Drug Facts

Product Profile

Brand Name xtracare with cooling action oatmeal skin relief calmin
Generic Name dimethicone
Labeler rejoice international
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

dimethicone 3 g/227g

Manufacturer
Rejoice International

Identifiers & Regulatory

Product NDC 57337-055
Product ID 57337-055_126e086f-ebd9-cffb-e063-6294a90afdc5
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 57337055
Hyphenated Format 57337-055

Supplemental Identifiers

RxCUI
891710
UPC
0849607052971
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 with cooling action oatmeal skin relief calmin (source: ndc)
Generic Name dimethicone (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 g/227g
source: ndc
Packaging
  • 227 g in 1 BOTTLE (57337-055-01)
source: ndc

Packages (1)

57337-055-01 227 g in 1 BOTTLE (57337-055-01)

Ingredients (1)

dimethicone (3 g/227g)

Linked Drug Pages (1)

XtraCare with cooling action Oatmeal Skin Relief Calmin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "126e086f-ebd9-cffb-e063-6294a90afdc5", "openfda": {"nui": ["N0000010282"], "upc": ["0849607052971"], "unii": ["92RU3N3Y1O"], "rxcui": ["891710"], "spl_set_id": ["29abd476-c32d-49f0-b283-30f4ba570ab4"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Rejoice International"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "227 g in 1 BOTTLE (57337-055-01)", "package_ndc": "57337-055-01", "marketing_start_date": "20131126"}], "brand_name": "XtraCare with cooling action Oatmeal Skin Relief Calmin", "product_id": "57337-055_126e086f-ebd9-cffb-e063-6294a90afdc5", "dosage_form": "LOTION", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "57337-055", "generic_name": "Dimethicone", "labeler_name": "Rejoice International", "product_type": "HUMAN OTC DRUG", "brand_name_base": "XtraCare with cooling action Oatmeal Skin Relief Calmin", "active_ingredients": [{"name": "DIMETHICONE", "strength": "3 g/227g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20131126", "listing_expiration_date": "20261231"}