NDC Package 10216-3091-1 Topex Pina Colada

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
10216-3091-1
Package Description:
100 g in 1 JAR
Product Code:
Proprietary Name:
Topex Pina Colada
Usage Information:
Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intraoral radiographs.
11-Digit NDC Billing Format:
10216309101
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
  • Labeler Name:
    Dentsply Caulk
    Sample Package:
    No
    Start Marketing Date:
    02-19-1963
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    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 10216-3091-1?

    The NDC Packaged Code 10216-3091-1 is assigned to a package of 100 g in 1 jar of Topex Pina Colada, labeled by Dentsply Caulk. The product's dosage form is and is administered via form.

    Is NDC 10216-3091 included in the NDC Directory?

    No, Topex Pina Colada with product code 10216-3091 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Dentsply Caulk on February 19, 1963 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 10216-3091-1?

    The 11-digit format is 10216309101. 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
    5-4-110216-3091-15-4-210216-3091-01