Double X Concentrated Mouthwash
NDC Package 76670-0012-2

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

Package Information

Double X Concentrated (cetylpyridinium chloride) mouthwashes is ■ Add a 5 drops of this solution to the enclosed cup, add water to the marked line (20ml).■ Adults and children 12 years of age and older: vigorously 1/2 oz. This formulation utilizes a mouthwash delivery system. Marketed by Docsmedi Co., Ltd., this product is identified by NDC 76670-0012 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
76670-0012-2
Package Description
2 CONTAINER in 1 CARTON / 30 mL in 1 CONTAINER (76670-0012-1)
Product Code
76670-0012
11-Digit Billing Format
76670001202
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Double X Concentrated
Non-Proprietary Name
Cetylpyridinium Chloride
Substance Name
Cetylpyridinium Chloride
Dosage Form
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETYLPYRIDINIUM CHLORIDE 2.3 g/100mL
Usage Information
■ Add a 5 drops of this solution to the enclosed cup, add water to the marked line (20ml).■ Adults and children 12 years of age and older: vigorously 1/2 oz. (20ml) of rinse, twice a day, for 30seconds and then spit out.■ Children 6 years to under 12 years: supervise use.■ Children under 6 years of age: do not use

Regulatory & Marketing

Labeler Name
Docsmedi Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-02-2022
Listing Expiration
12-31-2026
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 76670-0012-2 identifies a specific commercial package of 2 container in 1 carton / 30 ml in 1 container (76670-0012-1) of Double X Concentrated, a human over the counter drug labeled by Docsmedi Co., Ltd.. This mouthwash 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 Docsmedi Co., Ltd. on January 02, 2022. The current certification is valid through December 31, 2026.

How is this Docsmedi Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76670001202. 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 (5-4-1)
76670-0012-2
11-Digit CMS (5-4-2)
76670-0012-02

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