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  5. NDC Package Code: 55319-079-04 Childrens Cold And Cough Nighttime

NDC Package 55319-079-04 Childrens Cold And Cough Nighttime

Diphenhydramine Hcl,Phenylephrine Hcl Liquid Oral - 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:
55319-079-04
Package Description:
1 BOTTLE, PLASTIC in 1 BOX / 118 mL in 1 BOTTLE, PLASTIC
Product Code:
55319-079
Proprietary Name:
Childrens Cold And Cough Nighttime
Non-Proprietary Name:
Diphenhydramine Hcl, Phenylephrine Hcl
Substance Name:
Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride
Usage Information:
Do not give more than 6 doses in 24 hours unless directed by a doctor.mL = millilitermeasure only with dosing cup provided. Do not use any other dosing device.keep dosing cup with productAgeDose  children 6 to under 12 years10 mL every 4 hours children 4 to under 6 yearsdo not use unless directed by a doctor children under 4 years do not use 
11-Digit NDC Billing Format:
55319007904
NDC to RxNorm Crosswalk:
  • RxCUI: 1236048 - diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1236048 - diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1236048 - diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution
  • RxCUI: 1236048 - diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Family Dollar (family Wellness)
    Dosage Form:
    Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DIPHENHYDRAMINE HYDROCHLORIDE 6.25 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • 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:
    11-30-2014
    End Marketing Date:
    11-30-2025
    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 55319-079-04?

    The NDC Packaged Code 55319-079-04 is assigned to a package of 1 bottle, plastic in 1 box / 118 ml in 1 bottle, plastic of Childrens Cold And Cough Nighttime, a human over the counter drug labeled by Family Dollar (family Wellness). The product's dosage form is liquid and is administered via oral form.

    Is NDC 55319-079 included in the NDC Directory?

    Yes, Childrens Cold And Cough Nighttime with product code 55319-079 is active and included in the NDC Directory. The product was first marketed by Family Dollar (family Wellness) on November 30, 2014.

    What is the 11-digit format for NDC 55319-079-04?

    The 11-digit format is 55319007904. 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
    5-3-255319-079-045-4-255319-0079-04