Texaclear All Season Allergy Relief Solution/ Drops
NDC Package 58809-213-01

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

Texaclear All Season Allergy Relief (antigens all zones grasses trees and weeds. baptisia tinctoria, echinacea, hydrastis canadensis, myrrha, nasturtium aquaticum, phytolacca decandra, urtica urens) solution/ dropses is measure only with enclosed dropper provided.Adults 12 years and older: 10-15 drops, 3 times per day, hold under the tongue for at least 30 seconds before swallowing.Consult a doctor for use in children under 12. This formulation utilizes a solution/ drops delivery system. Marketed by Gm Pharmaceuticals, Inc, this product is identified by NDC 58809-213.

Identification & Billing

NDC Package Code
58809-213-01
Package Description
30 mL in 1 BOTTLE, DROPPER
Product Code
58809-213
11-Digit Billing Format
58809021301

Clinical Specifications

Proprietary Name
Texaclear All Season Allergy Relief
Non-Proprietary Name
Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens
Substance Name
Acacia Dealbata Pollen; Acer Negundo Pollen; Acer Saccharum Pollen; Amaranthus Palmeri Pollen; Amaranthus Retroflexus Pollen; Amaranthus Spinosus Pollen; Amaranthus Tuberculatus Pollen; Ambrosia Acanthicarpa Pollen; Ambrosia Artemisiifolia Pollen; Ambrosia Bidentata Pollen; Ambrosia Confertiflora Pollen; Ambrosia Psilostachya Pollen; Ambrosia Trifida Pollen; Anthoxanthum Odoratum Pollen; Artemisia Tridentata Pollen; Artemisia Vulgaris Pollen; Atriplex Wrightii Pollen; Avena Sativa Pollen; Baptisia Tinctoria Root; Bassia Scoparia Pollen; Betula Nigra Pollen; Broussonetia Papyrifera Pollen; Carya Illinoinensis Pollen; Carya Ovata Pollen; Celtis Occidentalis Pollen; Chenopodium Album Pollen; Cyclachaena Xanthifolia Pollen; Distichlis Spicata Pollen; Echinacea Angustifolia Root; Eucalyptus Globulus Pollen; Eupatorium Capillifolium Pollen; Fagus Grandifolia Pollen; Fraxinus Americana Pollen; Fraxinus Velutina Pollen; Goldenseal; Hesperocyparis Arizonica Pollen; Holcus Lanatus Pollen; Juglans Nigra Pollen; Juniperus Ashei Pollen; Juniperus Occidentalis Pollen; Juniperus Virginiana Pollen; Ligustrum Vulgare Pollen; Liquidambar Styraciflua Pollen; Melaleuca Quinquenervia Pollen; Morus Alba Pollen; Morus Rubra Pollen; Myrica Cerifera Pollen; Myrrh; Nasturtium Officinale; Olea Europaea Pollen; Paspalum Notatum Pollen; Phytolacca Americana Root; Pinus Echinata Pollen; Pinus Strobus Pollen; Plantago Lanceolata Pollen; Platanus Occidentalis Pollen; Poa Pratensis Pollen; Populus Alba Pollen; Populus Deltoides Subsp. Deltoides Pollen; Populus Deltoides Subsp. Monilifera Pollen; Populus Nigra Pollen; Prosopis Juliflora Pollen; Quercus Alba Pollen; Quercus Gambelii Pollen; Quercus Macrocarpa Pollen; Quercus Nigra Pollen; Quercus Rubra Pollen; Quercus Stellata Pollen; Quercus Virginiana Pollen; Rumex Acetosella Pollen; Rumex Crispus Pollen; Salix Nigra Pollen; Salsola Kali Pollen; Schinus Molle Pollen; Secale Cereale Pollen; Solidago Canadensis Pollen; Sorghum Halepense Pollen; Syagrus Romanzoffiana Pollen; Taxodium Distichum Pollen; Triticum Aestivum Pollen; Ulmus Americana Pollen; Urtica Dioica Pollen; Urtica Urens Whole; Xanthium Strumarium Pollen; Zea Mays Pollen
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Sublingual - Administration beneath the tongue.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Measure only with enclosed dropper provided.Adults 12 years and older: 10-15 drops, 3 times per day, hold under the tongue for at least 30 seconds before swallowing.Consult a doctor for use in children under 12

Regulatory & Marketing

Labeler Name
Gm Pharmaceuticals, Inc
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
11-10-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58809-213). Click a package code to view its specific billing and regulatory data.

58809-213-02
60 mL in 1 BOTTLE, DROPPER

* 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 58809-213-01 identifies a specific commercial package of 30 ml in 1 bottle, dropper of Texaclear All Season Allergy Relief, a human over the counter drug labeled by Gm Pharmaceuticals, Inc. This solution/ drops is formulated for sublingual use and contains acacia dealbata pollen; acer negundo pollen; acer saccharum pollen; amaranthus palmeri pollen; amaranthus retroflexus pollen; amaranthus spinosus pollen; amaranthus tuberculatus pollen; ambrosia acanthicarpa pollen; ambrosia artemisiifolia pollen; ambrosia bidentata pollen; ambrosia confertiflora pollen; ambrosia psilostachya pollen; ambrosia trifida pollen; anthoxanthum odoratum pollen; artemisia tridentata pollen; artemisia vulgaris pollen; atriplex wrightii pollen; avena sativa pollen; baptisia tinctoria root; bassia scoparia pollen; betula nigra pollen; broussonetia papyrifera pollen; carya illinoinensis pollen; carya ovata pollen; celtis occidentalis pollen; chenopodium album pollen; cyclachaena xanthifolia pollen; distichlis spicata pollen; echinacea angustifolia root; eucalyptus globulus pollen; eupatorium capillifolium pollen; fagus grandifolia pollen; fraxinus americana pollen; fraxinus velutina pollen; goldenseal; hesperocyparis arizonica pollen; holcus lanatus pollen; juglans nigra pollen; juniperus ashei pollen; juniperus occidentalis pollen; juniperus virginiana pollen; ligustrum vulgare pollen; liquidambar styraciflua pollen; melaleuca quinquenervia pollen; morus alba pollen; morus rubra pollen; myrica cerifera pollen; myrrh; nasturtium officinale; olea europaea pollen; paspalum notatum pollen; phytolacca americana root; pinus echinata pollen; pinus strobus pollen; plantago lanceolata pollen; platanus occidentalis pollen; poa pratensis pollen; populus alba pollen; populus deltoides subsp. deltoides pollen; populus deltoides subsp. monilifera pollen; populus nigra pollen; prosopis juliflora pollen; quercus alba pollen; quercus gambelii pollen; quercus macrocarpa pollen; quercus nigra pollen; quercus rubra pollen; quercus stellata pollen; quercus virginiana pollen; rumex acetosella pollen; rumex crispus pollen; salix nigra pollen; salsola kali pollen; schinus molle pollen; secale cereale pollen; solidago canadensis pollen; sorghum halepense pollen; syagrus romanzoffiana pollen; taxodium distichum pollen; triticum aestivum pollen; ulmus americana pollen; urtica dioica pollen; urtica urens whole; xanthium strumarium pollen; zea mays pollen 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 November 10, 2023. 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: 58809021301. 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)
58809-213-01
11-Digit CMS (5-4-2)
58809-0213-01

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