Twice. Oral Wellness Gum Shield Rinse
NDC Package 72164-009-20

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

Package Information

Twice. Oral Wellness Gum Shield (cetylpyridinium chloride) rinses is adults and children 12 years of age and older: Vigorously swish 20 mL of rinse between your teeth a day for 30 seconds and then split it our. This formulation utilizes a rinse delivery system. Marketed by Twice Twice Llc, this product is identified by NDC 72164-009 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
72164-009-20
Package Description
591 mL in 1 BOTTLE
Product Code
72164-009
11-Digit Billing Format
72164000920
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Twice. Oral Wellness Gum Shield
Non-Proprietary Name
Cetylpyridinium Chloride
Substance Name
Cetylpyridinium Chloride
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETYLPYRIDINIUM CHLORIDE .5 mg/mL
Usage Information
Adults and children 12 years of age and older: Vigorously swish 20 mL of rinse between your teeth a day for 30 seconds and then split it our. Do not swallow the rinse.Children 6 years to under 12 yaers: Supervise use.Children under 6 years: Do not use.

Regulatory & Marketing

Labeler Name
Twice Twice Llc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-01-2025
Listing Expiration
12-31-2027
Exclude Flag
N
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 72164-009-20 identifies a specific commercial package of 591 ml in 1 bottle of Twice. Oral Wellness Gum Shield, a human over the counter drug labeled by Twice Twice Llc. This rinse is formulated for oral use and contains cetylpyridinium chloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Twice Twice Llc on August 01, 2025. The current certification is valid through December 31, 2027.

How is this Twice Twice Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72164000920. 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)
72164-009-20
11-Digit CMS (5-4-2)
72164-0009-20

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