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  5. NDC Package Code: 61577-8120-9 Arthritis Pain Relief Cream

NDC Package 61577-8120-9 Arthritis Pain Relief Cream

Histamine Dihydrochloride Cream Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
61577-8120-9
Package Description:
266 g in 1 JAR
Product Code:
61577-8120
Proprietary Name:
Arthritis Pain Relief Cream
Non-Proprietary Name:
Histamine Dihydrochloride
Substance Name:
Histamine Dihydrochloride
Usage Information:
​For Use by Adults and Children over 12 years.  ​Apply a thin layer to pain site and massage until thoroughly absorbed into skin.  Apply no more than 3 to 4 times daily.Children 12 years or younger consult a physician
11-Digit NDC Billing Format:
61577812009
Product Type:
Human Otc Drug
Labeler Name:
Sombra Cosmetics, Inc.
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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):
  • HISTAMINE DIHYDROCHLORIDE .00025 g/g
    • Sample Package:
    No
    FDA Application Number:
    part348
    Marketing Category:
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date:
    12-09-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    61577-8120-259 g in 1 JAR
    61577-8120-359 g in 1 TUBE
    61577-8120-4119 g in 1 JAR

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61577-8120-9?

    The NDC Packaged Code 61577-8120-9 is assigned to a package of 266 g in 1 jar of Arthritis Pain Relief Cream, a human over the counter drug labeled by Sombra Cosmetics, Inc.. The product's dosage form is cream and is administered via topical form.

    Is NDC 61577-8120 included in the NDC Directory?

    Yes, Arthritis Pain Relief Cream with product code 61577-8120 is active and included in the NDC Directory. The product was first marketed by Sombra Cosmetics, Inc. on December 09, 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 61577-8120-9?

    The 11-digit format is 61577812009. 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
    5-4-161577-8120-95-4-261577-8120-09