NDC Package 53041-616-58 Tussnex Fm Cold And Sinus

Acteaminophen,Guaifenesin,Phenylephrine Hcl Liquid Oral - View Billable Units, 11-Digit Format, RxNorm

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:
53041-616-58
Package Description:
177 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Tussnex Fm Cold And Sinus
Non-Proprietary Name:
Acteaminophen, Guaifenesin, Phenylephrine Hcl
Substance Name:
Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
Do not take more than directed (see overdose warning)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 doctorAdults and children 12 years and older: 20 mL in dosing cup provided every 4 hours.Children under 12 years of age: Do not use
11-Digit NDC Billing Format:
53041061658
NDC to RxNorm Crosswalk:
  • RxCUI: 1116568 - acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution
  • RxCUI: 1116568 - acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1116568 - acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution
  • RxCUI: 1116568 - acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution
  • RxCUI: 1116568 - APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution
  • 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.
  • 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:
    12-01-2012
    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 53041-616-58?

    The NDC Packaged Code 53041-616-58 is assigned to a package of 177 ml in 1 bottle of Tussnex Fm Cold And Sinus, 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 53041-616 included in the NDC Directory?

    Yes, Tussnex Fm Cold And Sinus with product code 53041-616 is active and included in the NDC Directory. The product was first marketed by Guardian Drug Company on December 01, 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 53041-616-58?

    The 11-digit format is 53041061658. 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
    5-3-253041-616-585-4-253041-0616-58