Cepacol Lozenge
NDC Package 63824-744-16

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

Package Information

Cepacol (benzocaine and dextromethorphan hydrobromide) lozenges is adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctorchildren 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctorchildren under 6 years of age: do not use. This formulation utilizes a lozenge delivery system. Marketed by Reckitt Benckiser Llc, this product is identified by NDC 63824-744 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
63824-744-16
Package Description
2 BLISTER PACK in 1 CARTON / 8 LOZENGE in 1 BLISTER PACK
Product Code
63824-744
11-Digit Billing Format
63824074416
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk
  • RxCUI: 1039251 - dextromethorphan HBr 5 MG / benzocaine 7.5 MG Oral Lozenge
  • RxCUI: 1039251 - benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral Lozenge
  • RxCUI: 1039255 - Cepacol Sore Throat Plus Cough 7.5 MG / 5 MG Oral Lozenge
  • RxCUI: 1039255 - benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral Lozenge [Cepacol Sore Throat Plus Cough]
  • RxCUI: 1039255 - Cepacol Sore Throat Plus Cough (benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG) Oral Lozenge

Clinical Specifications

Proprietary Name
Cepacol Extra Strength Sore Throat And Cough
Non-Proprietary Name
Benzocaine And Dextromethorphan Hydrobromide
Substance Name
Benzocaine; Dextromethorphan Hydrobromide
Dosage Form
Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctorchildren 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctorchildren under 6 years of age: do not use

Regulatory & Marketing

Labeler Name
Reckitt Benckiser Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-05-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63824-744). Click a package code to view its specific billing and regulatory data.

63824-744-36
3 BLISTER PACK in 1 CARTON / 12 LOZENGE in 1 BLISTER PACK
63824-744-94
1 BLISTER PACK in 1 CARTON / 4 LOZENGE in 1 BLISTER PACK

* 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 63824-744-16 identifies a specific commercial package of 2 blister pack in 1 carton / 8 lozenge in 1 blister pack of Cepacol Extra Strength Sore Throat And Cough, a human over the counter drug labeled by Reckitt Benckiser Llc. This lozenge is formulated for oral use and contains benzocaine; dextromethorphan hydrobromide 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 May 05, 2014. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63824074416. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 total billable units per package. 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)
63824-744-16
11-Digit CMS (5-4-2)
63824-0744-16

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