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  5. NDC Package Code: 55319-378-04 Cold And Cough Day Time Childrens

NDC Package 55319-378-04 Cold And Cough Day Time Childrens

Dextromethorphan Hbr,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:
55319-378-04
Package Description:
1 BOTTLE, PLASTIC in 1 BOX / 118 mL in 1 BOTTLE, PLASTIC
Product Code:
55319-378
Proprietary Name:
Cold And Cough Day Time Childrens
Non-Proprietary Name:
Dextromethorphan Hbr, Phenylephrine Hcl
Substance Name:
Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Usage Information:
Do not take more than 6 doses in any 24-hour periodmeasure only with dosing cup provided. Do not use any other dosing devicekeep dosing cup with productmL = millilitershake well before using age dose children 6 to under 12 years of age 10 mL every 4 hours children 4 to 5 years 5 mL every 4 hours children under 4 years do not use
11-Digit NDC Billing Format:
55319037804
NDC to RxNorm Crosswalk:
  • RxCUI: 1535366 - dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 mL Oral Suspension
  • RxCUI: 1535366 - dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Suspension
  • RxCUI: 1535366 - dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Suspension
    • 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):
  • DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
  • 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:
    08-31-2015
    End Marketing Date:
    08-31-2025
    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 55319-378-04?

    The NDC Packaged Code 55319-378-04 is assigned to a package of 1 bottle, plastic in 1 box / 118 ml in 1 bottle, plastic of Cold And Cough Day Time Childrens, 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 55319-378 included in the NDC Directory?

    Yes, Cold And Cough Day Time Childrens with product code 55319-378 is active and included in the NDC Directory. The product was first marketed by Family Dollar (family Wellness) on August 31, 2015.

    What is the 11-digit format for NDC 55319-378-04?

    The 11-digit format is 55319037804. 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
    5-3-255319-378-045-4-255319-0378-04