Childrens Sudafed Pe Solution
NDC Package 50580-784-04

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

Package Information

Childrens Sudafed Pe (phenylephrine hydrochloride) solution is find right dose on chart belowmL = milliliterrepeat dose every 4 hoursdo not use more than 6 times in 24 hoursAge (yr)Dose (mL)under 4 yearsdo not use4 to 5 years5 mL6 to 11 years10 mLAttention: use only enclosed dosing cup specifically designed for use with this product. This formulation utilizes a solution delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-784 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
50580-784-04
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
50580-784
11-Digit Billing Format
50580078404
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 692479 - phenylephrine HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 692479 - phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 692479 - phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Childrens Sudafed Pe Nasal Decongestant
Non-Proprietary Name
Phenylephrine Hydrochloride
Substance Name
Phenylephrine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
Pharmacologic Class
Usage Information
Find right dose on chart belowmL = milliliterrepeat dose every 4 hoursdo not use more than 6 times in 24 hoursAge (yr)Dose (mL)under 4 yearsdo not use4 to 5 years5 mL6 to 11 years10 mLAttention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Regulatory & Marketing

Labeler Name
Kenvue Brands Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-01-2008
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 50580-784-04 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Childrens Sudafed Pe Nasal Decongestant, a human over the counter drug labeled by Kenvue Brands Llc. This solution is formulated for oral use and contains 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 Kenvue Brands Llc on October 01, 2008. The current certification is valid through December 31, 2026.

How is this Kenvue Brands Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50580078404. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-3-2)
50580-784-04
11-Digit CMS (5-4-2)
50580-0784-04

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