1. Home
  2. Labeler Index
  3. Sombra Cosmetics Inc.
  4. 61577-2800
  5. NDC Package Code: 61577-2800-1 Deep Core Pain Relieving Gel Warm Therapy

NDC Package 61577-2800-1 Deep Core Pain Relieving Gel Warm Therapy

Menthol Camphor Gel 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:
61577-2800-1
Package Description:
85.05 g in 1 BOTTLE
Product Code:
61577-2800
Proprietary Name:
Deep Core Pain Relieving Gel Warm Therapy
Non-Proprietary Name:
Menthol Camphor
Substance Name:
Camphor (synthetic); Menthol
Usage Information:
Adults 18 years and above: Apply thin layer to the affected area not more than 3-4 times daily. Massage until cream absorbs into skin. Wash hands with water and soap after application. Adults and children 2 - 18 years of age consult a doctor before use. Children aged under 2, do not use.
11-Digit NDC Billing Format:
61577280001
Product Type:
Human Otc Drug
Labeler Name:
Sombra Cosmetics Inc.
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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):
  • CAMPHOR (SYNTHETIC) .03 g/.03g
  • MENTHOL .03 g/.03g
    • Sample Package:
    No
    FDA Application Number:
    M
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    03-01-2024
    Listing Expiration Date:
    12-31-2025
    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 61577-2800-1?

    The NDC Packaged Code 61577-2800-1 is assigned to a package of 85.05 g in 1 bottle of Deep Core Pain Relieving Gel Warm Therapy, a human over the counter drug labeled by Sombra Cosmetics Inc.. The product's dosage form is gel and is administered via topical form.

    Is NDC 61577-2800 included in the NDC Directory?

    Yes, Deep Core Pain Relieving Gel Warm Therapy with product code 61577-2800 is active and included in the NDC Directory. The product was first marketed by Sombra Cosmetics Inc. on March 01, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 61577-2800-1?

    The 11-digit format is 61577280001. 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
    5-4-161577-2800-15-4-261577-2800-01