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  5. NDC Package Code: 67091-258-54 Cold And Flu Relief Multi Symptom Nighttime

NDC Package 67091-258-54 Cold And Flu Relief Multi Symptom Nighttime

Acetaminophen,Dextromethorphan Hydrobromide,Doxylamine Succinate Liquid Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
67091-258-54
Package Description:
355 mL in 1 BOTTLE, PLASTIC
Product Code:
67091-258
Proprietary Name:
Cold And Flu Relief Multi Symptom Nighttime
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 period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliterkeep dosing cup with product adults 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 insure correct dosing
11-Digit NDC Billing Format:
67091025854
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:
    Winco Foods, Llc
    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:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    12-31-2014
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    67091-258-23237 mL in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 67091-258-54?

    The NDC Packaged Code 67091-258-54 is assigned to a package of 355 ml in 1 bottle, plastic of Cold And Flu Relief Multi Symptom Nighttime, a human over the counter drug labeled by Winco Foods, Llc. The product's dosage form is liquid and is administered via oral form.

    Is NDC 67091-258 included in the NDC Directory?

    Yes, Cold And Flu Relief Multi Symptom Nighttime with product code 67091-258 is active and included in the NDC Directory. The product was first marketed by Winco Foods, Llc on December 31, 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 67091-258-54?

    The 11-digit format is 67091025854. 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
    5-3-267091-258-545-4-267091-0258-54