NDC Package 58809-950-08 Texaclear Kids Cough And Cold

Dextromethorphan Hbr Guaifenesin Phenyephrine 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:
58809-950-08
Package Description:
237 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Texaclear Kids Cough And Cold
Non-Proprietary Name:
Dextromethorphan Hbr Guaifenesin Phenyephrine Hcl
Substance Name:
Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
■ do not exceed 6 doses per 24-hour period■ use enclosed (30 mL) dose cup  ■ mL = milliliter■ dose every 4 hours■ adults and children 12 years and over:60 mL (2 dose cups)■ children 6 to under 12 years: 30 mL (1 dose cup)■ children under 6 years: do not use
11-Digit NDC Billing Format:
58809095008
NDC to RxNorm Crosswalk:
  • RxCUI: 1808192 - dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 30 mL Oral Solution
  • RxCUI: 1808192 - dextromethorphan hydrobromide 0.333 MG/ML / guaifenesin 6.67 MG/ML / phenylephrine hydrochloride 0.167 MG/ML Oral Solution
  • RxCUI: 1808192 - dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 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.
  • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    06-15-2015
    End Marketing 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 58809-950-08?

    The NDC Packaged Code 58809-950-08 is assigned to a package of 237 ml in 1 bottle of Texaclear Kids Cough And Cold, 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 58809-950 included in the NDC Directory?

    Yes, Texaclear Kids Cough And Cold with product code 58809-950 is active and included in the NDC Directory. The product was first marketed by Gm Pharmaceuticals, Inc on June 15, 2015.

    What is the 11-digit format for NDC 58809-950-08?

    The 11-digit format is 58809095008. 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
    5-3-258809-950-085-4-258809-0950-08