Antiseptic Rinse
NDC Package 11344-299-77

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

Package Information

Antiseptic (cetylpyridinium chloride) rinses is adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a daydo not swallowchildren 6 years to under 12 years of age: supervise usewhen used after brushing, rinse mouth with water firstchildren under 6 years of age: do not use. This formulation utilizes a rinse delivery system. Marketed by Nice-pak Products, Llc, this product is identified by NDC 11344-299 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
11344-299-77
Package Description
500 mL in 1 BOTTLE, PLASTIC
Product Code
11344-299
11-Digit Billing Format
11344029977
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Antiseptic
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 .7 mg/mL
Usage Information
Adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a daydo not swallowchildren 6 years to under 12 years of age: supervise usewhen used after brushing, rinse mouth with water firstchildren under 6 years of age: do not use

Regulatory & Marketing

Labeler Name
Nice-pak Products, Llc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-29-2024
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 11344-299-77 identifies a specific commercial package of 500 ml in 1 bottle, plastic of Antiseptic, a human over the counter drug labeled by Nice-pak Products, 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 Nice-pak Products, Llc on April 29, 2024. The current certification is valid through December 31, 2027.

How is this Nice-pak Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11344029977. 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)
11344-299-77
11-Digit CMS (5-4-2)
11344-0299-77

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