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  5. NDC Package Code: 0031-8716-12 Childrens Robitussin Cough And Cold Cf

NDC Package 0031-8716-12 Childrens Robitussin Cough And Cold Cf

Dextromethorphan Hydrobromide,Guaifenesin,And Phenylephrine Hydrochloride 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:
0031-8716-12
Package Description:
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code:
0031-8716
Proprietary Name:
Childrens Robitussin Cough And Cold Cf
Non-Proprietary Name:
Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Substance Name:
Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
Measure only with dosing cup providedkeep dosing cup with productml = milliliterdo not take more than 6 doses in any 24-hour periodagedosechildren under 4 yearsdo not usechildren 4 to under 6 years5 ml every 4 hourschildren 6 to under 12 years10 ml every 4 hoursadults and children 12 years and over20 ml every 4 hours
11-Digit NDC Billing Format:
00031871612
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1370205 - dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1370205 - dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1370205 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution
  • RxCUI: 1370205 - dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Haleon Us Holdings Llc
    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
  • GUAIFENESIN 50 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
  • Expectorant - [EPC] (Established Pharmacologic Class)
  • Increased Respiratory Secretions - [PE] (Physiologic Effect)
  • 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:
    M001
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    09-01-2009
    Listing Expiration Date:
    12-31-2025
    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 0031-8716-12?

    The NDC Packaged Code 0031-8716-12 is assigned to a package of 1 bottle in 1 carton / 118 ml in 1 bottle of Childrens Robitussin Cough And Cold Cf, a human over the counter drug labeled by Haleon Us Holdings Llc. The product's dosage form is liquid and is administered via oral form.

    Is NDC 0031-8716 included in the NDC Directory?

    Yes, Childrens Robitussin Cough And Cold Cf with product code 0031-8716 is active and included in the NDC Directory. The product was first marketed by Haleon Us Holdings Llc on September 01, 2009 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0031-8716-12?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0031-8716-12?

    The 11-digit format is 00031871612. 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 4-4-2 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
    4-4-20031-8716-125-4-200031-8716-12