1. Home
  2. Labeler Index
  3. Pure Source, Llc
  4. 65121-828
  5. NDC Package Code: 65121-828-05 Painkoolers

NDC Package 65121-828-05 Painkoolers

Menthol,Capsaicin Patch 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:
65121-828-05
Package Description:
5 PATCH in 1 BOX / 8 g in 1 PATCH
Product Code:
65121-828
Proprietary Name:
Painkoolers
Non-Proprietary Name:
Menthol, Capsaicin
Substance Name:
Capsaicin; Menthol
Usage Information:
Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.Children under 12 years, consult physician before use.How to apply:Clean and dry affected areaCut open pouch and remove patchRemove protective film and apply directly to the area of painApply to affected area not more than 3 times dailyWash hands with soap after applying patchReseal pouch containing unsed patches
11-Digit NDC Billing Format:
65121082805
NDC to RxNorm Crosswalk:
  • RxCUI: 1300889 - capsaicin 0.0375 % / menthol 5 % Medicated Patch
  • RxCUI: 1300889 - capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG Medicated Patch
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Pure Source, Llc
    Dosage Form:
    Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
    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 .0375 g/100g
  • MENTHOL 5 g/100g
    • Sample Package:
    No
    FDA Application Number:
    M017
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    12-30-2014
    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 65121-828-05?

    The NDC Packaged Code 65121-828-05 is assigned to a package of 5 patch in 1 box / 8 g in 1 patch of Painkoolers, a human over the counter drug labeled by Pure Source, Llc. The product's dosage form is patch and is administered via topical form.

    Is NDC 65121-828 included in the NDC Directory?

    Yes, Painkoolers with product code 65121-828 is active and included in the NDC Directory. The product was first marketed by Pure Source, Llc on December 30, 2014 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 65121-828-05?

    The 11-digit format is 65121082805. 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
    5-3-265121-828-055-4-265121-0828-05