Childrens Pediaclear Pd Liquid
NDC Package 58809-651-50

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

Package Information

Childrens Pediaclear Pd (triprolidine hydrochloride) liquids is ■ use only with enclosed dropper■ do not use dropper for any other drug product■ mL= milliliter■ Professional Labeling: Take under guidance of health professionals.children 6 to under 12 years of age:       2 mL every 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor. This formulation utilizes a liquid delivery system. Marketed by Gm Pharmaceuticals, Inc, this product is identified by NDC 58809-651 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
58809-651-50
Package Description
50 mL in 1 BOTTLE, DROPPER
Product Code
58809-651
11-Digit Billing Format
58809065150
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
50 ML
RxNorm Crosswalk
  • RxCUI: 1428927 - triprolidine HCl 0.625 MG in 1 mL Oral Solution
  • RxCUI: 1428927 - triprolidine hydrochloride 0.625 MG/ML Oral Solution
  • RxCUI: 1428927 - triprolidine hydrochloride 0.625 MG per 1 ML Oral Solution
  • RxCUI: 1428927 - triprolidine hydrochloride 1.25 MG per 2 ML Oral Solution
  • RxCUI: 2179647 - Pediaclear Childrens PD 1.25 MG in 2 mL Oral Solution

Clinical Specifications

Proprietary Name
Childrens Pediaclear Pd
Non-Proprietary Name
Triprolidine Hydrochloride
Substance Name
Triprolidine 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)
TRIPROLIDINE HYDROCHLORIDE 1.25 mg/2mL
Usage Information
■ use only with enclosed dropper■ do not use dropper for any other drug product■ mL= milliliter■ Professional Labeling: Take under guidance of health professionals.children 6 to under 12 years of age:       2 mL every 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.       children 4 to under 6 years of age:       1.5 mL ever 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.             children 2 to under 4 years of age:       1 mL ever 6 hours, not to exceed 4 doses in 24 hoursor as directed by a doctor.infants 4 months to under 2 years of age: .5 mL every 6 hours, not to exceed 4 doses in 24 hours or as directed by a doctor.

Regulatory & Marketing

Labeler Name
Gm Pharmaceuticals, Inc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2019
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 58809-651-50 identifies a specific commercial package of 50 ml in 1 bottle, dropper of Childrens Pediaclear Pd, a human over the counter drug labeled by Gm Pharmaceuticals, Inc. This product is billed per "ML" milliliter and contains an estimated amount of 50 billable units per package. This liquid is formulated for oral use and contains triprolidine 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 Gm Pharmaceuticals, Inc on July 01, 2019. The current certification is valid through December 31, 2026.

How is this Gm Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58809065150. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 50 total billable units per package. 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)
58809-651-50
11-Digit CMS (5-4-2)
58809-0651-50

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