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  5. NDC Package Code: 53943-508-28 Night-time Cough Relief

NDC Package 53943-508-28 Night-time Cough Relief

Dextromethorphan Hydrobromide,Doxylamine Succinate 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:
53943-508-28
Package Description:
354 mL in 1 BOTTLE
Product Code:
53943-508
Proprietary Name:
Night-time Cough Relief
Non-Proprietary Name:
Dextromethorphan Hydrobromide, Doxylamine Succinate
Substance Name:
Dextromethorphan Hydrobromide; Doxylamine Succinate
Usage Information:
Use dose cup or tablespoon (TBSP)do not exceed 4 doses per 24 hoursWhen using Day Time and Night Time products, carefully read each label to ensure adults and children 12 years and over 30 mL (2 TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use
11-Digit NDC Billing Format:
53943050828
NDC to RxNorm Crosswalk:
  • RxCUI: 1234386 - dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
  • RxCUI: 1234386 - dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • RxCUI: 1234386 - dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
  • RxCUI: 1234386 - dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Discount Drug Mart
    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):
  • DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL
  • DOXYLAMINE SUCCINATE 12.5 mg/30mL
    • Pharmacologic Class(es):
  • Antihistamine - [EPC] (Established Pharmacologic Class)
  • Histamine Receptor Antagonists - [MoA] (Mechanism of Action)
  • 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:
    10-27-2014
    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 53943-508-28?

    The NDC Packaged Code 53943-508-28 is assigned to a package of 354 ml in 1 bottle of Night-time Cough Relief, a human over the counter drug labeled by Discount Drug Mart. The product's dosage form is liquid and is administered via oral form.

    Is NDC 53943-508 included in the NDC Directory?

    Yes, Night-time Cough Relief with product code 53943-508 is active and included in the NDC Directory. The product was first marketed by Discount Drug Mart on October 27, 2014 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 53943-508-28?

    The 11-digit format is 53943050828. 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
    5-3-253943-508-285-4-253943-0508-28