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  5. NDC Package Code: 58809-346-08 Texaclear Congestion And Pain Sinus Relief

NDC Package 58809-346-08 Texaclear Congestion And Pain Sinus Relief

Choline Salicylate, Guaifenesin,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:
58809-346-08
Package Description:
237 mL in 1 BOTTLE, PLASTIC
Product Code:
58809-346
Proprietary Name:
Texaclear Congestion And Pain Sinus Relief
Non-Proprietary Name:
Choline Salicylate, Guaifenesin, Phenylephrine Hydrochloride
Substance Name:
Choline Salicylate; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
Do not exceed recommended dosage.do not take more than 6 doses in any 24-hour period.use enclosed dose cupkeep dosage cup with productmL= milliliteradults and children 12 years of age and over:30 mL every 4 hourschildren under 12 years of age:do not use.
11-Digit NDC Billing Format:
58809034608
NDC to RxNorm Crosswalk:
  • RxCUI: 1653155 - choline salicylate 870 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution
  • RxCUI: 1653155 - choline salicylate 29 MG/ML / guaifenesin 6.67 MG/ML / phenylephrine hydrochloride 0.33 MG/ML Oral Solution
  • RxCUI: 1653155 - choline salicylate 870 MG / guaifenesin 200 MG / phenylephrine HCl 10 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
  • GUAIFENESIN 200 mg/30mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL
    • 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)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    10-21-2014
    End Marketing Date:
    09-30-2024
    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 58809-346-08?

    The NDC Packaged Code 58809-346-08 is assigned to a package of 237 ml in 1 bottle, plastic of Texaclear Congestion And Pain Sinus Relief, 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 58809-346 included in the NDC Directory?

    Yes, Texaclear Congestion And Pain Sinus Relief with product code 58809-346 is active and included in the NDC Directory. The product was first marketed by Gm Pharmaceuticals, Inc on October 21, 2014.

    What is the 11-digit format for NDC 58809-346-08?

    The 11-digit format is 58809034608. 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
    5-3-258809-346-085-4-258809-0346-08