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  5. NDC Package Code: 58443-0548-3 Glad Skin Eczema Cream

NDC Package 58443-0548-3 Glad Skin Eczema Cream

Colloidal Oatmeal Lotion Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
58443-0548-3
Package Description:
50 mL in 1 BOTTLE, PUMP
Product Code:
58443-0548
Proprietary Name:
Glad Skin Eczema Cream
Non-Proprietary Name:
Colloidal Oatmeal
Substance Name:
Oatmeal
Usage Information:
Apply twice daily, or more as desired, on skin free of other products.Let the cream absorb into skin for 5 minutes before applying other products.
11-Digit NDC Billing Format:
58443054803
Product Type:
Human Otc Drug
Labeler Name:
Prime Enterprises
Dosage Form:
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
Administration Route(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • OATMEAL .175 mg/mL
    • Pharmacologic Class(es):
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Dietary Proteins - [CS]
  • Grain Proteins - [EXT]
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Plant Proteins - [CS]
    • Sample Package:
    No
    FDA Application Number:
    part347
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    12-06-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58443-0548-3?

    The NDC Packaged Code 58443-0548-3 is assigned to a package of 50 ml in 1 bottle, pump of Glad Skin Eczema Cream, a human over the counter drug labeled by Prime Enterprises. The product's dosage form is lotion and is administered via topical form.

    Is NDC 58443-0548 included in the NDC Directory?

    Yes, Glad Skin Eczema Cream with product code 58443-0548 is active and included in the NDC Directory. The product was first marketed by Prime Enterprises on December 06, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 58443-0548-3?

    The 11-digit format is 58443054803. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-158443-0548-35-4-258443-0548-03