NDC Package 43493-0012-0 Kalaya Extra Strength Pain Relief Gel With Arnica

Methyl Salicylate,Menthol,Camphor Gel Topical - View Billable Units, 11-Digit Format, RxNorm

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:
43493-0012-0
Package Description:
1 TUBE in 1 CARTON / 100 g in 1 TUBE
Product Code:
Proprietary Name:
Kalaya Extra Strength Pain Relief Gel With Arnica
Non-Proprietary Name:
Methyl Salicylate, Menthol, Camphor
Substance Name:
Camphor (synthetic); Levomenthol; Methyl Salicylate
Usage Information:
Adults and children 12 years and over. Use no more than 3-4 times daily. Apply cream to affected areas and thoroughly massage until penetrated. Wash hands with soap and water after use.
11-Digit NDC Billing Format:
43493001200
Product Type:
Human Otc Drug
Labeler Name:
Avaria Health & Beauty Corp
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.
  • Sample Package:
    No
    FDA Application Number:
    M017
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    02-16-2023
    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 43493-0012-0?

    The NDC Packaged Code 43493-0012-0 is assigned to a package of 1 tube in 1 carton / 100 g in 1 tube of Kalaya Extra Strength Pain Relief Gel With Arnica, a human over the counter drug labeled by Avaria Health & Beauty Corp. The product's dosage form is gel and is administered via topical form.

    Is NDC 43493-0012 included in the NDC Directory?

    Yes, Kalaya Extra Strength Pain Relief Gel With Arnica with product code 43493-0012 is active and included in the NDC Directory. The product was first marketed by Avaria Health & Beauty Corp on February 16, 2023 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 43493-0012-0?

    The 11-digit format is 43493001200. 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
    5-4-143493-0012-05-4-243493-0012-00