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  5. NDC Package Code: 55319-813-16 Daytime Nighttime Severe Cold And Flu

NDC Package 55319-813-16 Daytime Nighttime Severe Cold And Flu

Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl Doxylaminesucinate 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:
55319-813-16
Package Description:
1 KIT in 1 KIT * 237 mL in 1 BOTTLE * 237 mL in 1 BOTTLE
Product Code:
55319-813
Proprietary Name:
Daytime Nighttime Severe Cold And Flu
Non-Proprietary Name:
Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl Doxylaminesucinate
Usage Information:
DAYTIMEdo not take more than directed (see Overdose warning)do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL= milliliter adults and children 12 years and over30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 yearsask a doctor children under 4 years do not use NIGHTTIMEtake only as directed (see Overdose warning)Do not exceed 4 doses per 24 hoursmeasure only with dosing cup provided. Do not use any other dosing device.   mL= milliliterkeep dosing cup with productadults and children 12 years and over: 30 mL every 4 hourschildren under 12 years of age: do not usewhen using other Daytime or Nighttime products, carefully read each label or ensure correct dosing
11-Digit NDC Billing Format:
55319081316
NDC to RxNorm Crosswalk:
  • RxCUI: 1369842 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution
  • RxCUI: 1369842 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution
  • RxCUI: 1369842 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution
  • RxCUI: 1369842 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution
  • RxCUI: 1369842 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Family Dollar (family Wellness)
    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:
    07-31-2019
    End Marketing Date:
    07-31-2025
    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 55319-813-16?

    The NDC Packaged Code 55319-813-16 is assigned to a package of 1 kit in 1 kit * 237 ml in 1 bottle * 237 ml in 1 bottle of Daytime Nighttime Severe Cold And Flu, a human over the counter drug labeled by Family Dollar (family Wellness). The product's dosage form is kit and is administered via form.

    Is NDC 55319-813 included in the NDC Directory?

    Yes, Daytime Nighttime Severe Cold And Flu with product code 55319-813 is active and included in the NDC Directory. The product was first marketed by Family Dollar (family Wellness) on July 31, 2019.

    What is the 11-digit format for NDC 55319-813-16?

    The 11-digit format is 55319081316. 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
    5-3-255319-813-165-4-255319-0813-16