Childrens Delsym Solution
NDC Package 63824-212-64

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

Package Information

Childrens Delsym (acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride) solution is this product does not contain directions or complete warnings for adult usedo not give more than directed (see Overdose warning)measure only with dosing cup provideddo not use dosing cup with other productsdose as follows or as directed by a doctorchildren 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour periodchildren under 6 years of age: do not use. This formulation utilizes a solution delivery system. Marketed by Reckitt Benckiser Llc, this product is identified by NDC 63824-212 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
63824-212-64
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
63824-212
11-Digit Billing Format
63824021264
RxNorm Crosswalk
  • RxCUI: 1375932 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution
  • RxCUI: 1375932 - acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1375932 - acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution
  • RxCUI: 1375932 - acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution
  • RxCUI: 1375932 - APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Childrens Delsym Cough Plus Cold Night Time
Non-Proprietary Name
Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Diphenhydramine Hydrochloride; 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)
Pharmacologic Class
Usage Information
This product does not contain directions or complete warnings for adult usedo not give more than directed (see Overdose warning)measure only with dosing cup provideddo not use dosing cup with other productsdose as follows or as directed by a doctorchildren 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour periodchildren under 6 years of age: do not use

Regulatory & Marketing

Labeler Name
Reckitt Benckiser Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-18-2013
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63824-212). Click a package code to view its specific billing and regulatory data.

63824-212-66
180 mL in 1 BOTTLE

* 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 63824-212-64 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Childrens Delsym Cough Plus Cold Night Time, a human over the counter drug labeled by Reckitt Benckiser Llc. This solution is formulated for oral use and contains acetaminophen; 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 Reckitt Benckiser Llc on March 18, 2013. The current certification is valid through December 31, 2027.

How is this Reckitt Benckiser Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63824021264. 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)
63824-212-64
11-Digit CMS (5-4-2)
63824-0212-64

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