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  5. NDC Package Code: 49580-0416-8 Severe Cold And Flu Nighttime

NDC Package 49580-0416-8 Severe Cold And Flu Nighttime

Acetaminophen,Dextromethorphan Hydrobromide,Doxylamine Succinate,Phenylephrine Hci Liquid - 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:
49580-0416-8
Package Description:
237 mL in 1 BOTTLE, PLASTIC
Product Code:
49580-0416
Proprietary Name:
Severe Cold And Flu Nighttime
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hci
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride
Usage Information:
Take only as directed - see Overdose warningmL = milliliter use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. do not exceed 4 doses per 24 hours adults and children 12 years and over: 30 mL every 4 hours children under 12 years of age: do not use When using Day Time or Night Time products, carefully read each label to ensure correct dosing.
11-Digit NDC Billing Format:
49580041608
NDC to RxNorm Crosswalk:
  • RxCUI: 1431245 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution
  • RxCUI: 1431245 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution
  • RxCUI: 1431245 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution
  • RxCUI: 1431245 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution
  • RxCUI: 1431245 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    P & L Development, 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 20 mg/30mL
  • DOXYLAMINE SUCCINATE 12.5 mg/30mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • 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)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • 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:
    08-31-2015
    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 49580-0416-8?

    The NDC Packaged Code 49580-0416-8 is assigned to a package of 237 ml in 1 bottle, plastic of Severe Cold And Flu Nighttime, a human over the counter drug labeled by P & L Development, Llc. The product's dosage form is liquid and is administered via oral form.

    Is NDC 49580-0416 included in the NDC Directory?

    Yes, Severe Cold And Flu Nighttime with product code 49580-0416 is active and included in the NDC Directory. The product was first marketed by P & L Development, Llc on August 31, 2015 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 49580-0416-8?

    The 11-digit format is 49580041608. 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
    5-4-149580-0416-85-4-249580-0416-08