Texaclear Kids Allergy Liquid
NDC Package 58809-925-08

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

Package Information

Texaclear Kids Allergy (chlophedianol hcl pyrilamine maleate) liquids is ▪ do not exceed 4 doses per 24 hours▪ mL= milliliter▪ use enclosed dose cup and keep with productadults and children 12 years of age and over:60 mL (2 dose cups) every 6 to 8 hourschildren 6 to under 12 years of age:30 mL (1 dose cup) every 6 to 8 hourschildren under 6 years:do not use. This formulation utilizes a liquid delivery system. Marketed by Gm Pharmaceuticals, Inc., this product is identified by NDC 58809-925 and is authorized under FDA application M12.

Identification & Billing

NDC Package Code
58809-925-08
Package Description
237 mL in 1 BOTTLE
Product Code
58809-925
11-Digit Billing Format
58809092508
RxNorm Crosswalk
  • RxCUI: 1808189 - chlophedianol HCl 12.5 MG / pyrilamine maleate 25 MG in 30 mL Oral Solution
  • RxCUI: 1808189 - chlophedianol hydrochloride 0.417 MG/ML / pyrilamine maleate 0.833 MG/ML Oral Solution
  • RxCUI: 1808189 - chlophedianol HCl 12.5 MG / pyrilamine maleate 25 MG per 30 ML Oral Solution

Clinical Specifications

Proprietary Name
Texaclear Kids Allergy
Non-Proprietary Name
Chlophedianol Hcl Pyrilamine Maleate
Substance Name
Chlophedianol Hydrochloride; 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)
Usage Information
▪ do not exceed 4 doses per 24 hours▪ mL= milliliter▪ use enclosed dose cup and keep with productadults and children 12 years of age and over:60 mL (2 dose cups) every 6 to 8 hourschildren 6 to under 12 years of age:30 mL (1 dose cup) every 6 to 8 hourschildren under 6 years:do not use.

Regulatory & Marketing

Labeler Name
Gm Pharmaceuticals, Inc.
Product Type
Human Otc Drug
FDA Application #
M12
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-15-2016
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 58809-925-08 identifies a specific commercial package of 237 ml in 1 bottle of Texaclear Kids Allergy, a human over the counter drug labeled by Gm Pharmaceuticals, Inc.. This liquid is formulated for oral use and contains chlophedianol hydrochloride; 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 June 15, 2016. 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: 58809092508. 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)
58809-925-08
11-Digit CMS (5-4-2)
58809-0925-08

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