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  5. NDC Package Code: 49580-0304-4 Pain Relief Plus Multi Symptom Cold Childrens

NDC Package 49580-0304-4 Pain Relief Plus Multi Symptom Cold Childrens

Acetaminophen,Chlorpheniramine Maleate,Dextromethorphan Hbr,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:
49580-0304-4
Package Description:
1 BOTTLE, PLASTIC in 1 BOX / 118 mL in 1 BOTTLE, PLASTIC
Product Code:
49580-0304
Proprietary Name:
Pain Relief Plus Multi Symptom Cold Childrens
Non-Proprietary Name:
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl
Substance Name:
Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Usage Information:
This product does not contain directions or complete warnings for adult usemL=millilitershake well before usingdo not give more than 5 doses in any 24-hour periodmeasure only with dosing cup provided. Do not use any other dosing device keep dosing cup with productif needed, repeat dose every 4 hours while symptoms lastfind the right dose on chart below. If possible, use weight to dose; otherwise, use age Weight (lb)Age (yr) Dose (mL)48-956-1110 mL36-47  4-5do not use unless directed by a doctor under 36under 4do not use
11-Digit NDC Billing Format:
49580030404
NDC to RxNorm Crosswalk:
  • RxCUI: 1357553 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1357553 - acetaminophen 32 MG/ML / chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1357553 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution
  • RxCUI: 1357553 - acetaminophen 320 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution
  • RxCUI: 1357553 - APAP 32 MG/ML / Chlorpheniramine Maleate 0.2 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 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 160 mg/5mL
  • CHLORPHENIRAMINE MALEATE 1 mg/5mL
  • DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
    • 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)
  • 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:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    03-26-2021
    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 49580-0304-4?

    The NDC Packaged Code 49580-0304-4 is assigned to a package of 1 bottle, plastic in 1 box / 118 ml in 1 bottle, plastic of Pain Relief Plus Multi Symptom Cold Childrens, 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 49580-0304 included in the NDC Directory?

    Yes, Pain Relief Plus Multi Symptom Cold Childrens with product code 49580-0304 is active and included in the NDC Directory. The product was first marketed by P & L Development, Llc on March 26, 2021 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 49580-0304-4?

    The 11-digit format is 49580030404. 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
    5-4-149580-0304-45-4-249580-0304-04