Cvs Pharmacy Kit
NDC Package 51316-635-08

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

Package Information

Cvs Pharmacy (brompheniramine maleate, dextromethorphan hbr, diphenhydramine hcl) kits is cold & Cough▪do not take more than 6 doses in any 24-hour period ▪measure only with dosing cup provided.▪Keep dosage cup with product▪mL= milliliteragedoseAdults and children 12 years and over20 mL every 4 hourschildren 6 to under 12 years 10 mL every 4 hourschildren under 6 yearsdo not useNighttime cold & cough▪do not take more than 6 doses in any 24-hour period ▪measure only with dosing cup provided.▪Keep dosage cup with product▪mL= milliliteragedose Adults and children 12 years and over 20 mL every 4 hours children 6 to under 12 years10 mL every 4 hours children under 6 yearsdo not use. This formulation utilizes a kit delivery system. Marketed by Cvs Pharmacy, Inc., this product is identified by NDC 51316-635 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
51316-635-08
Package Description
1 KIT in 1 KIT * 118 mL in 1 BOTTLE, PLASTIC (51316-632-04) * 118 mL in 1 BOTTLE, PLASTIC (51316-646-04)
Product Code
51316-635
11-Digit Billing Format
51316063508
RxNorm Crosswalk
  • RxCUI: 1049884 - diphenhydrAMINE HCl 50 MG in 40 mL Oral Solution
  • RxCUI: 1049884 - diphenhydramine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 1049884 - diphenhydramine hydrochloride 50 MG per 40 ML Oral Solution
  • RxCUI: 2683421 - brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG in 10 mL Oral Solution
  • RxCUI: 2683421 - brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Cvs Pharmacy Cold And Cough And Nighttime Value Pack
Non-Proprietary Name
Brompheniramine Maleate, Dextromethorphan Hbr, Diphenhydramine Hcl
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Cold & Cough▪do not take more than 6 doses in any 24-hour period ▪measure only with dosing cup provided.▪Keep dosage cup with product▪mL= milliliteragedoseAdults and children 12 years and over20 mL every 4 hourschildren 6 to under 12 years 10 mL every 4 hourschildren under 6 yearsdo not useNighttime cold & cough▪do not take more than 6 doses in any 24-hour period ▪measure only with dosing cup provided.▪Keep dosage cup with product▪mL= milliliteragedose Adults and children 12 years and over 20 mL every 4 hours children 6 to under 12 years10 mL every 4 hours children under 6 yearsdo not use

Regulatory & Marketing

Labeler Name
Cvs Pharmacy, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-03-2025
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 51316-635-08 identifies a specific commercial package of 1 kit in 1 kit * 118 ml in 1 bottle, plastic (51316-632-04) * 118 ml in 1 bottle, plastic (51316-646-04) of Cvs Pharmacy Cold And Cough And Nighttime Value Pack, a human over the counter drug labeled by Cvs Pharmacy, Inc.. This kit is formulated for use and contains 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 Cvs Pharmacy, Inc. on March 03, 2025. The current certification is valid through December 31, 2026.

How is this Cvs Pharmacy, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316063508. 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)
51316-635-08
11-Digit CMS (5-4-2)
51316-0635-08

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