Guna-oral Spray
NDC Package 17089-452-27

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

Package Information

Guna-oral (achillea millefolium - aconitum napellus - arnica montana - atropa belladonna - calcium sulfide - comfrey root - echinacea angustifolia - echinacea purpurea - hypericum perforatum - sus scrofa tooth - witch hazel -) sprays is adults and children 12 years and older                2 sprays to back of throat, 3-5 times per dayChildren between 12 years and 6 years of age    1 spray to back of throat, 3-5 times per dayChildren under 6 years                                     1 spray to back of throat, 3 times per day. This formulation utilizes a spray delivery system. Marketed by Guna Spa, this product is identified by NDC 17089-452.

Identification & Billing

NDC Package Code
17089-452-27
Package Description
1 BOTTLE, SPRAY in 1 BOX / 50 mL in 1 BOTTLE, SPRAY
Product Code
17089-452
11-Digit Billing Format
17089045227

Clinical Specifications

Proprietary Name
Guna-oral
Non-Proprietary Name
Achillea Millefolium - Aconitum Napellus - Arnica Montana - Atropa Belladonna - Calcium Sulfide - Comfrey Root - Echinacea Angustifolia - Echinacea Purpurea - Hypericum Perforatum - Sus Scrofa Tooth - Witch Hazel -
Substance Name
Achillea Millefolium; Aconitum Napellus; Arnica Montana; Atropa Belladonna; Calcium Sulfide; Comfrey Root; Echinacea Angustifolia; Echinacea Purpurea; Hypericum Perforatum; Sus Scrofa Tooth; Witch Hazel
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
Adults and children 12 years and older                2 sprays to back of throat, 3-5 times per dayChildren between 12 years and 6 years of age    1 spray to back of throat, 3-5 times per dayChildren under 6 years                                     1 spray to back of throat, 3 times per day

Regulatory & Marketing

Labeler Name
Guna Spa
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
05-27-2010
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 17089-452-27 identifies a specific commercial package of 1 bottle, spray in 1 box / 50 ml in 1 bottle, spray of Guna-oral, a human over the counter drug labeled by Guna Spa. This spray is formulated for oral use and contains achillea millefolium; aconitum napellus; arnica montana; atropa belladonna; calcium sulfide; comfrey root; echinacea angustifolia; echinacea purpurea; hypericum perforatum; sus scrofa tooth; witch hazel 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 Guna Spa on May 27, 2010. The current certification is valid through December 31, 2026.

How is this Guna Spa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17089045227. 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)
17089-452-27
11-Digit CMS (5-4-2)
17089-0452-27

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