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  5. NDC Package Code: 36800-512-29 Topcare Oral Pain Relief Maximum Strength

NDC Package 36800-512-29 Topcare Oral Pain Relief Maximum Strength

Benzocaine 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:
36800-512-29
Package Description:
1 TUBE in 1 CARTON / 14 g in 1 TUBE
Product Code:
36800-512
Proprietary Name:
Topcare Oral Pain Relief Maximum Strength
Non-Proprietary Name:
Benzocaine
Substance Name:
Benzocaine
Usage Information:
Usefor the temporary relief of pain due to toothaches
11-Digit NDC Billing Format:
36800051229
NDC to RxNorm Crosswalk:
  • RxCUI: 238910 - benzocaine 20 % Oral Gel
  • RxCUI: 238910 - benzocaine 0.2 MG/MG Oral Gel
  • RxCUI: 238910 - benzocaine 20 % (180-220 MG per 1 GM) Oral Gel
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Topco Associates Llc
    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):
  • BENZOCAINE 20 g/100g
    • Pharmacologic Class(es):
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    part356
    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:
    03-05-2019
    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.

    Frequently Asked Questions

    What is NDC 36800-512-29?

    The NDC Packaged Code 36800-512-29 is assigned to a package of 1 tube in 1 carton / 14 g in 1 tube of Topcare Oral Pain Relief Maximum Strength, a human over the counter drug labeled by Topco Associates Llc. The product's dosage form is gel and is administered via topical form.

    Is NDC 36800-512 included in the NDC Directory?

    Yes, Topcare Oral Pain Relief Maximum Strength with product code 36800-512 is active and included in the NDC Directory. The product was first marketed by Topco Associates Llc on March 05, 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 36800-512-29?

    The 11-digit format is 36800051229. 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
    5-3-236800-512-295-4-236800-0512-29