Cepacol Liquid
NDC Package 63824-790-80

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

Package Information

Cepacol (cetylpyridinium chloride) liquids is adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. This formulation utilizes a liquid delivery system. Marketed by Reckitt Benckiser Llc, this product is identified by NDC 63824-790 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
63824-790-80
Package Description
1 BOTTLE in 1 CARTON / 710 mL in 1 BOTTLE
Product Code
63824-790
11-Digit Billing Format
63824079080
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cepacol Antibacterial
Non-Proprietary Name
Cetylpyridinium Chloride
Substance Name
Cetylpyridinium Chloride
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETYLPYRIDINIUM CHLORIDE .05 g/100mL
Usage Information
Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinsechildren 6 years to under 12 years of age: supervise usechildren under 6 years of age: do not use.

Regulatory & Marketing

Labeler Name
Reckitt Benckiser Llc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-22-2011
End Marketing Date
09-03-2027
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 63824-790-80 identifies a specific commercial package of 1 bottle in 1 carton / 710 ml in 1 bottle of Cepacol Antibacterial, a human over the counter drug labeled by Reckitt Benckiser Llc. This liquid 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 Reckitt Benckiser Llc on June 22, 2011.

How is this Reckitt Benckiser Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63824079080. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
63824-790-80
11-Digit CMS (5-4-2)
63824-0790-80

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