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  5. NDC Package Code: 58809-217-08 Texaclear Severe Cough, Cold And Flu

NDC Package 58809-217-08 Texaclear Severe Cough, Cold And Flu

Choline Salicylate,Dextromethorphan Hydrobromide,Guaifenesin 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:
58809-217-08
Package Description:
237 mL in 1 BOTTLE, PLASTIC
Product Code:
58809-217
Proprietary Name:
Texaclear Severe Cough, Cold And Flu
Non-Proprietary Name:
Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin
Substance Name:
Choline Salicylate; Dextromethorphan Hydrobromide; Guaifenesin
Usage Information:
Do not exceed recommended dosage. do not take more than 6 doses in any 24-hour period.use enclosed dose cup and keep with productmL= milliliteradults and children 12 years of age and over:30 mL every 4 hours.children under 12 years of age:do not use
11-Digit NDC Billing Format:
58809021708
NDC to RxNorm Crosswalk:
  • RxCUI: 2670541 - choline salicylate 870 MG / dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 30 mL Oral Solution
  • RxCUI: 2670541 - choline salicylate 29 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral Solution
  • RxCUI: 2670541 - choline salicylate 870 MG / dextromethorphan HBr 20 MG / guaifenesin 200 MG per 30 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Gm Pharmaceuticals, Inc
    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):
  • CHOLINE SALICYLATE 870 mg/30mL
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL
  • GUAIFENESIN 200 mg/30mL
    • Pharmacologic Class(es):
  • 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)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    10-25-2023
    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 58809-217-08?

    The NDC Packaged Code 58809-217-08 is assigned to a package of 237 ml in 1 bottle, plastic of Texaclear Severe Cough, Cold And Flu, a human over the counter drug labeled by Gm Pharmaceuticals, Inc. The product's dosage form is liquid and is administered via oral form.

    Is NDC 58809-217 included in the NDC Directory?

    Yes, Texaclear Severe Cough, Cold And Flu with product code 58809-217 is active and included in the NDC Directory. The product was first marketed by Gm Pharmaceuticals, Inc on October 25, 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 58809-217-08?

    The 11-digit format is 58809021708. 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
    5-3-258809-217-085-4-258809-0217-08