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  5. NDC Package Code: 53041-622-03 Childrens Tussnex

NDC Package 53041-622-03 Childrens Tussnex

Acteaminophen,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:
53041-622-03
Package Description:
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code:
53041-622
Proprietary Name:
Childrens Tussnex
Non-Proprietary Name:
Acteaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
This product does not contain directions or complete warnings for adult dose do not take more than directed (see overdose warning)shake well before usedo not take more than 5 doses in any 24 hour periodif needed, repeat dose every 4 hours while symptoms lastdo not give more than 5 days unless directed by a doctormeasure only with dosing cup provideddo not use dosing cup with other productsdose as follows or as directed by a doctorChildren 6 to under 12 years of age: 10 mL in dosing cup provided Children under 6 years of age: Do not use
11-Digit NDC Billing Format:
53041062203
NDC to RxNorm Crosswalk:
  • RxCUI: 1593450 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Suspension
  • RxCUI: 1593450 - acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Suspension
  • RxCUI: 1593450 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Suspension
  • RxCUI: 1593450 - acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Suspension
  • RxCUI: 1593450 - APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Suspension
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Guardian Drug Company
    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):
  • ACETAMINOPHEN 325 mg/10mL
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL
  • GUAIFENESIN 200 mg/10mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL
    • 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:
    05-05-2012
    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 53041-622-03?

    The NDC Packaged Code 53041-622-03 is assigned to a package of 1 bottle in 1 carton / 118 ml in 1 bottle of Childrens Tussnex, a human over the counter drug labeled by Guardian Drug Company. The product's dosage form is liquid and is administered via oral form.

    Is NDC 53041-622 included in the NDC Directory?

    Yes, Childrens Tussnex with product code 53041-622 is active and included in the NDC Directory. The product was first marketed by Guardian Drug Company on May 05, 2012 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 53041-622-03?

    The 11-digit format is 53041062203. 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
    5-3-253041-622-035-4-253041-0622-03