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  5. NDC Package Code: 82501-3431-2 Nighttime Cold And Flu

NDC Package 82501-3431-2 Nighttime Cold And Flu

Acetaminophen,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:
82501-3431-2
Package Description:
355 mL in 1 BOTTLE, PLASTIC
Product Code:
82501-3431
Proprietary Name:
Nighttime Cold And Flu
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Usage Information:
Do not take more than directed (see Overdose warning)do not take more than 4 doses in any 24-hour periodmeasure only with dosing cup provided. Do not use any other dosing device.mL= milliliter keep dosing cup with productadults and children 12 years and over: 30 mL every 6 hourschildren under 12 years of age: do not useWhen using other Day Time or Night Time products, carefully read each label to ensure correct dosing
11-Digit NDC Billing Format:
82501343102
NDC to RxNorm Crosswalk:
  • RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
  • RxCUI: 1043400 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • RxCUI: 1043400 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
  • RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
  • RxCUI: 1043400 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Gobrands, Inc. (goodnow)
    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):
  • ACETAMINOPHEN 650 mg/30mL
  • 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:
    04-29-2022
    Listing Expiration Date:
    12-31-2025
    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 82501-3431-2?

    The NDC Packaged Code 82501-3431-2 is assigned to a package of 355 ml in 1 bottle, plastic of Nighttime Cold And Flu, a human over the counter drug labeled by Gobrands, Inc. (goodnow). The product's dosage form is liquid and is administered via oral form.

    Is NDC 82501-3431 included in the NDC Directory?

    Yes, Nighttime Cold And Flu with product code 82501-3431 is active and included in the NDC Directory. The product was first marketed by Gobrands, Inc. (goodnow) on April 29, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 82501-3431-2?

    The 11-digit format is 82501343102. 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 5-4-1 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
    5-4-182501-3431-25-4-282501-3431-02