Severe Congestion, Cough, Cold And Flu Relief Kit
NDC Package 51316-463-99
Package Information
Severe Congestion, Cough, Cold And Flu Relief (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl) kits is do not take more than directeddo not take more than 6 doses in any 24-hour periodmL = milliliter; FL OZ = fluid ounceonly use the dose cup providedadults and children 12 years and over: 20 mL in dosing cup provided every 4 hourschildren under 12 years: do not use do not take more than directeddo not take more than 4 doses in any 24-hour periodmL = milliliter; FL OZ = fluid ounceonly use the dose cup providedadults and children 12 years and over: 20 mL in dosing cup provided every 4 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 51316-463 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1043543 - dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
- RxCUI: 1043543 - dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
- RxCUI: 1043543 - dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution
- RxCUI: 1043543 - dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution
- RxCUI: 2173667 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 51316 - Cvs Woonsocket Prescription Center, Incorporated
- 51316-463 - Severe Congestion, Cough, Cold And Flu Relief
- 51316-463-99 - 1 KIT in 1 PACKAGE * 177 mL in 1 BOTTLE, PLASTIC (51316-004-45) * 177 mL in 1 BOTTLE, PLASTIC (51316-063-45)
- 51316-463 - Severe Congestion, Cough, Cold And Flu Relief
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 51316-463-99 identifies a specific commercial package of 1 kit in 1 package * 177 ml in 1 bottle, plastic (51316-004-45) * 177 ml in 1 bottle, plastic (51316-063-45) of Severe Congestion, Cough, Cold And Flu Relief Maximum Strength, 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 May 27, 2022. The current certification is valid through December 31, 2026.
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: 51316046399. 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.
