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  5. NDC Package Code: 70000-0629-1 Leader Childrens Multi Symptom Cold

NDC Package 70000-0629-1 Leader Childrens Multi Symptom Cold

Dextromethorphan Hbr,Guaifenesin,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:
70000-0629-1
Package Description:
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code:
70000-0629
Proprietary Name:
Leader Childrens Multi Symptom Cold
Non-Proprietary Name:
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Substance Name:
Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
Do not take more than 6 doses in any 24-hour periodmeasure only with dosing cup provideddo not use dosing cup with other productsdose as follows or as directed by a doctorAge Dose children 6 years to under 12 years10 mL every 4 hourschildren 4 years to under 6 years5 mL every 4 hourschildren under 4 yearsdo not usemL=milliliter
11-Digit NDC Billing Format:
70000062901
NDC to RxNorm Crosswalk:
  • RxCUI: 1043543 - dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1043543 - dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1043543 - dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution
  • RxCUI: 1043543 - dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Cardinal Health 110, Llc. Dba Leader
    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 100 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:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    03-15-2023
    Listing Expiration Date:
    12-31-2024
    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 70000-0629-1?

    The NDC Packaged Code 70000-0629-1 is assigned to a package of 1 bottle in 1 carton / 118 ml in 1 bottle of Leader Childrens Multi Symptom Cold, a human over the counter drug labeled by Cardinal Health 110, Llc. Dba Leader. The product's dosage form is liquid and is administered via oral form.

    Is NDC 70000-0629 included in the NDC Directory?

    Yes, Leader Childrens Multi Symptom Cold with product code 70000-0629 is active and included in the NDC Directory. The product was first marketed by Cardinal Health 110, Llc. Dba Leader on March 15, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70000-0629-1?

    The 11-digit format is 70000062901. 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 5-4-1 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
    5-4-170000-0629-15-4-270000-0629-01