Pediacare Childrens Cough And Congestion Grape Syrup
NDC Package 52412-992-01

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

Package Information

Pediacare Childrens Cough And Congestion Grape (dextromethorphan hydrobromide and guaifenesin) syrups is do not take more than 6 doses in any 24-hour periodmeasure only with dosing cup providedkeep dosing cup with productmL=milliliterAGEDOSEchildren under 4 yearsdo not usechildren 4 to under 6 years5 mL every 4 hourschildren 6 to under 12 years10 mL every 4 hoursadults and children 12 years and over20 mL every 4 hours. This formulation utilizes a syrup delivery system. Marketed by Randob Labs,ltd. Dba Crossingwell Consumer Health, this product is identified by NDC 52412-992 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
52412-992-01
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
52412-992
11-Digit Billing Format
52412099201
RxNorm Crosswalk
  • RxCUI: 1020138 - dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution
  • RxCUI: 1020138 - dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 1020138 - dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution
  • RxCUI: 1020138 - dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Pediacare Childrens Cough And Congestion Grape
Non-Proprietary Name
Dextromethorphan Hydrobromide And Guaifenesin
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
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 periodmeasure only with dosing cup providedkeep dosing cup with productmL=milliliterAGEDOSEchildren under 4 yearsdo not usechildren 4 to under 6 years5 mL every 4 hourschildren 6 to under 12 years10 mL every 4 hoursadults and children 12 years and over20 mL every 4 hours

Regulatory & Marketing

Labeler Name
Randob Labs,ltd. Dba Crossingwell Consumer Health
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-03-2023
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 52412-992-01 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Pediacare Childrens Cough And Congestion Grape, a human over the counter drug labeled by Randob Labs,ltd. Dba Crossingwell Consumer Health. This syrup is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin 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 Randob Labs,ltd. Dba Crossingwell Consumer Health on January 03, 2023. The current certification is valid through December 31, 2026.

How is this Randob Labs,ltd. Dba Crossingwell Consumer Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52412099201. 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)
52412-992-01
11-Digit CMS (5-4-2)
52412-0992-01

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