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  5. NDC Package Code: 83538-102-18 Oprava

NDC Package 83538-102-18 Oprava

Methyl Salicylate,Menthol,Capsaicin Cream 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:
83538-102-18
Package Description:
237 mL in 1 BOTTLE
Product Code:
83538-102
Proprietary Name:
Oprava
Non-Proprietary Name:
Methyl Salicylate, Menthol, Capsaicin
Substance Name:
Capsaicin; Menthol; Methyl Salicylate
Usage Information:
APPLY GENEROUSLY.GENTLY MASSAGE INTO PAINFUL AREA UNTIL THOROUGHLY ABSORBED.REPEAT AS NECESSARY, UP TO FOUR TIMES DAILY.PRODUCT CAN BE USED WITH A WRAP.
11-Digit NDC Billing Format:
83538010218
NDC to RxNorm Crosswalk:
  • RxCUI: 2644111 - capsaicin 0.03 % / menthol 1 % / methyl salicylate 10 % Topical Cream
  • RxCUI: 2644111 - capsaicin 0.3 MG/ML / menthol 10 MG/ML / methyl salicylate 100 MG/ML Topical Cream
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Biological M.d. Solutions Llc
    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):
  • CAPSAICIN .03 g/100mL
  • MENTHOL 1 g/100mL
  • METHYL SALICYLATE 10 g/100mL
    • 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:
    08-08-2023
    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 83538-102-18?

    The NDC Packaged Code 83538-102-18 is assigned to a package of 237 ml in 1 bottle of Oprava, a human over the counter drug labeled by Biological M.d. Solutions Llc. The product's dosage form is cream and is administered via topical form.

    Is NDC 83538-102 included in the NDC Directory?

    Yes, Oprava with product code 83538-102 is active and included in the NDC Directory. The product was first marketed by Biological M.d. Solutions Llc on August 08, 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 83538-102-18?

    The 11-digit format is 83538010218. 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 5-3-2 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
    5-3-283538-102-185-4-283538-0102-18