Childrens Pediaclear 8 Liquid
NDC Package 58809-770-08

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

Package Information

Childrens Pediaclear 8 (pyrilamine maleate) liquids is ■ use only with enclosed dose cup and keep with product■ mL= milliliter■ professional labeling: for use under guidance of health professional only children 6 to under 12 years of age: 30 mL (2 dose cups) every 6 to 8 hours, not to exceed 4 doses in 24 hours. children 2 to under 6 years of age:15 mL (1 dose cup) every 6 to 8 hours, not to exceed 4 doses in 24 hours. This formulation utilizes a liquid delivery system. Marketed by Gm Pharmaceuticals, Inc, this product is identified by NDC 58809-770 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
58809-770-08
Package Description
237 mL in 1 BOTTLE
Product Code
58809-770
11-Digit Billing Format
58809077008
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
237 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Childrens Pediaclear 8
Non-Proprietary Name
Pyrilamine Maleate
Substance Name
Pyrilamine Maleate
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)
PYRILAMINE MALEATE 12.5 mg/15mL
Usage Information
■ use only with enclosed dose cup and keep with product■ mL= milliliter■ professional labeling: for use under guidance of health professional only children 6 to under 12 years of age: 30 mL (2 dose cups) every 6 to 8 hours, not to exceed 4 doses in 24 hours. children 2 to under 6 years of age:15 mL (1 dose cup) every 6 to 8 hours, not to exceed 4 doses in 24 hours.

Regulatory & Marketing

Labeler Name
Gm Pharmaceuticals, Inc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-19-2019
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 58809-770-08 identifies a specific commercial package of 237 ml in 1 bottle of Childrens Pediaclear 8, a human over the counter drug labeled by Gm Pharmaceuticals, Inc. This product is billed per "ML" milliliter and contains an estimated amount of 237 billable units per package. This liquid is formulated for oral use and contains pyrilamine maleate 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 August 19, 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: 58809077008. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 237 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)
58809-770-08
11-Digit CMS (5-4-2)
58809-0770-08

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