Cold And Flu Kit
NDC Package 51316-123-96
Package Information
Cold And Flu (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl) kits is do not take more than directeddo not exceed 4 doses per 24 hoursmL = milliliteronly use the dose cup providedadults and children 12 years and over30 mL every 4 hourschildren 6 to under 12 years15 mL every 4 hourschildren under 6 yearsdo not use do not take more than directeddo not exceed 4 doses per 24 hoursmL = milliliteronly use the dose cup providedadults and children 12 years and over: 30 mL every 6 hourschildren under 12 years: do not use. This formulation utilizes a kit delivery system. Marketed by Cvs Woonsocket Prescription Center, Incorporated, this product is identified by NDC 51316-123 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
- RxCUI: 1043400 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
- RxCUI: 1043400 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
- RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
- RxCUI: 1043400 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 51316 - Cvs Woonsocket Prescription Center, Incorporated
- 51316-123 - Cold And Flu
- 51316-123-96 - 1 KIT in 1 CARTON * 355 mL in 1 BOTTLE, PLASTIC (51316-120-02) * 355 mL in 1 BOTTLE, PLASTIC (51316-130-02)
- 51316-123 - Cold And Flu
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 (51316-123). Click a package code to view its specific billing and regulatory data.
* 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 51316-123-96 identifies a specific commercial package of 1 kit in 1 carton * 355 ml in 1 bottle, plastic (51316-120-02) * 355 ml in 1 bottle, plastic (51316-130-02) of Cold And Flu Daytime Nighttime, a human over the counter drug labeled by Cvs Woonsocket Prescription Center, Incorporated. 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 Woonsocket Prescription Center, Incorporated on July 28, 2023. The current certification is valid through December 31, 2027.
How is this Cvs Woonsocket Prescription Center, Incorporated product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316012396. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
