Cold And Congestion Liquid
NDC Package 0363-0058-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cold And Congestion (diphenhydramine hci, phenylephrine hcl) liquids is do not take more than 6 doses in any 24-hour period do not exceed recommended dosage measure only with dosing cup provided. This formulation utilizes a liquid delivery system. Marketed by Walgreens, this product is identified by NDC 0363-0058 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0363-0058-04
Package Description
118 mL in 1 BOTTLE, PLASTIC
Product Code
0363-0058
11-Digit Billing Format
00363005804
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

Clinical Specifications

Proprietary Name
Cold And Congestion Childrens Nighttime
Non-Proprietary Name
Diphenhydramine Hci, Phenylephrine Hcl
Substance Name
Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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

Regulatory & Marketing

Labeler Name
Walgreens
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-31-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0363-0058-04 identifies a specific commercial package of 118 ml in 1 bottle, plastic of Cold And Congestion Childrens Nighttime, a human over the counter drug labeled by Walgreens. This liquid is formulated for oral use and contains diphenhydramine hydrochloride; phenylephrine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Walgreens on March 31, 2016. The current certification is valid through December 31, 2026.

How is this Walgreens product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00363005804. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0363-0058-04
11-Digit CMS (5-4-2)
00363-0058-04

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.