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  5. NDC Package Code: 0363-0058-04 Cold And Congestion Childrens Nighttime

NDC Package 0363-0058-04 Cold And Congestion Childrens Nighttime

Diphenhydramine Hci,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:
0363-0058-04
Package Description:
118 mL in 1 BOTTLE, PLASTIC
Product Code:
0363-0058
Proprietary Name:
Cold And Congestion Childrens Nighttime
Non-Proprietary Name:
Diphenhydramine Hci, Phenylephrine Hcl
Substance Name:
Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride
Usage Information:
Do not take more than 6 doses in any 24-hour period do not exceed recommended dosage measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter  age doseadults and children 12 years and over20 mL every 4 hours children 6 to 11 years 10 mL every 4 hours children under 6 yearsdo not use
11-Digit NDC Billing Format:
00363005804
NDC to RxNorm Crosswalk:
  • RxCUI: 1236048 - diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1236048 - diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1236048 - diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution
  • RxCUI: 1236048 - diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Walgreens
    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):
  • DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/10mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL
    • 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:
    03-31-2016
    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 0363-0058-04?

    The NDC Packaged Code 0363-0058-04 is assigned to a package of 118 ml in 1 bottle, plastic of Cold And Congestion Childrens Nighttime, a human over the counter drug labeled by Walgreens. The product's dosage form is liquid and is administered via oral form.

    Is NDC 0363-0058 included in the NDC Directory?

    Yes, Cold And Congestion Childrens Nighttime with product code 0363-0058 is active and included in the NDC Directory. The product was first marketed by Walgreens on March 31, 2016 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 0363-0058-04?

    The 11-digit format is 00363005804. 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 4-4-2 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
    4-4-20363-0058-045-4-200363-0058-04