Zzip Cold Sore Treatment
NDC Package 70019-100-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Zzip Cold Sore Treatment is ​adults and children 12 years or over:​ - Apply to affected area on face or lips at first sign (tingle) of cold sore/fever blister- Open tube, saturate cotton swab with 8 drops of liquid- Use the cotton swab to apply to affeted area on face or lips. Marketed by Zzip Ag, this product is identified by NDC 70019-100 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
70019-100-00
Package Description
3 mL in 1 TUBE
Product Code
70019-100
11-Digit Billing Format
70019010000
RxNorm Crosswalk
  • RxCUI: 1659645 - allantoin 0.5 % / dimethicone 1 % / menthol 0.1 % Topical Solution
  • RxCUI: 1659645 - allantoin 5 MG/ML / dimethicone 10 MG/ML / menthol 1 MG/ML Topical Solution
  • RxCUI: 1659650 - Zzip Cold Sore (allantoin 0.5 % / dimethicone 1 % / menthol 0.1 % ) Topical Solution
  • RxCUI: 1659650 - allantoin 5 MG/ML / dimethicone 10 MG/ML / menthol 1 MG/ML Topical Solution [Zzip]

Clinical Specifications

Proprietary Name
Zzip Cold Sore Treatment
Dosage Form
-
Usage Information
​adults and children 12 years or over:​ - Apply to affected area on face or lips at first sign (tingle) of cold sore/fever blister- Open tube, saturate cotton swab with 8 drops of liquid- Use the cotton swab to apply to affeted area on face or lips. Do ot touch the sore with your fingers. Continue for 3 seconds until the cold sore is completely covered and sealed.- Dispose of cotton swab - do not reuse- Wash hands before and after application.- Apply 2 times daily, not to exceed 3 to 4 times daily until sore is healed​children under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Zzip Ag
FDA Application #
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
07-30-2015
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70019-100-00 identifies a specific commercial package of 3 ml in 1 tube of Zzip Cold Sore Treatment, labeled by Zzip Ag. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Zzip Ag on July 30, 2015. The current certification is valid through December 31, 2017.

How is this Zzip Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70019010000. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70019-100-00
11-Digit CMS (5-4-2)
70019-0100-00

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.