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  5. NDC Package Code: 49580-0502-8 Nighttime Severe Cold And Cough

NDC Package 49580-0502-8 Nighttime Severe Cold And Cough

Acetaminophen,Diphenhydramine Hcl,Phenylephrine Hcl 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:
49580-0502-8
Package Description:
245 mL in 1 BOTTLE, PLASTIC
Product Code:
49580-0502
Proprietary Name:
Nighttime Severe Cold And Cough
Non-Proprietary Name:
Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Substance Name:
Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride
Usage Information:
Do not take more than directed (see overdose warning)do not take more than 6 doses (180 mL) in any 24-hour periodmeasure only with dosing cup provided. Do not use any other dosing devicemL=milliliterkeep dosing cup with productadults and children 12 years and over 30 mL every 4 hourschildren under 12 years of age; do not use 
11-Digit NDC Billing Format:
49580050208
NDC to RxNorm Crosswalk:
  • RxCUI: 1298348 - acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution
  • RxCUI: 1298348 - acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution
  • RxCUI: 1298348 - acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution
  • RxCUI: 1298348 - acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution
  • RxCUI: 1298348 - APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 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
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/30mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    04-30-2021
    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 49580-0502-8?

    The NDC Packaged Code 49580-0502-8 is assigned to a package of 245 ml in 1 bottle, plastic of Nighttime Severe Cold And Cough, 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 49580-0502 included in the NDC Directory?

    Yes, Nighttime Severe Cold And Cough with product code 49580-0502 is active and included in the NDC Directory. The product was first marketed by P & L Development, Llc on April 30, 2021 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 49580-0502-8?

    The 11-digit format is 49580050208. 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
    5-4-149580-0502-85-4-249580-0502-08