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  5. NDC Package Code: 51316-614-01 Severe Cold, Cold And Flu Maximum Strength, Daytime, Nightime

NDC Package 51316-614-01 Severe Cold, Cold And Flu Maximum Strength, Daytime, Nightime

Acetaminophen,Dextromethorphan Hbr,Diphenhydramine Hcl,Guaifenesin,Phenylephrine Hcl Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
51316-614-01
Package Description:
1 KIT in 1 CARTON * 10 TABLET, FILM COATED in 1 BLISTER PACK * 10 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
51316-614
Proprietary Name:
Severe Cold, Cold And Flu Maximum Strength, Daytime, Nightime
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hcl
Usage Information:
Do not take more than directeddo not take more than 12 caplets in any 24-hour periodadults and children 12 years and over: take 2 caplets every 4 hourschildren under 12 years: do not use
11-Digit NDC Billing Format:
51316061401
NDC to RxNorm Crosswalk:
  • RxCUI: 1110988 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1110988 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1110988 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1233575 - acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1233575 - acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Cvs Woonsocket Prescription Center, Incorporated
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    08-16-2022
    End Marketing Date:
    02-22-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 51316-614-01?

    The NDC Packaged Code 51316-614-01 is assigned to a package of 1 kit in 1 carton * 10 tablet, film coated in 1 blister pack * 10 tablet, film coated in 1 blister pack of Severe Cold, Cold And Flu Maximum Strength, Daytime, Nightime, a human over the counter drug labeled by Cvs Woonsocket Prescription Center, Incorporated. The product's dosage form is kit and is administered via form.

    Is NDC 51316-614 included in the NDC Directory?

    Yes, Severe Cold, Cold And Flu Maximum Strength, Daytime, Nightime with product code 51316-614 is active and included in the NDC Directory. The product was first marketed by Cvs Woonsocket Prescription Center, Incorporated on August 16, 2022.

    What is the 11-digit format for NDC 51316-614-01?

    The 11-digit format is 51316061401. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-251316-614-015-4-251316-0614-01