Stellalife Vega Oral Care Gel
NDC Package 69685-112-01

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

Package Information

Stellalife Vega Oral Care Gel (gel) gel is adults and children over 6 years of age: Shake well. This formulation utilizes a gel delivery system. Marketed by Stellalife, Inc., this product is identified by NDC 69685-112.

Identification & Billing

NDC Package Code
69685-112-01
Package Description
1 BOTTLE, PUMP in 1 BOX / 30 mL in 1 BOTTLE, PUMP
Product Code
69685-112
11-Digit Billing Format
69685011201

Clinical Specifications

Proprietary Name
Stellalife Vega Oral Care Gel
Non-Proprietary Name
Gel
Substance Name
Arnica Montana; Calcium Sulfide; Calendula Officinalis Flowering Top; Delphinium Staphisagria Seed; Echinacea Angustifolia; Echinacea Purpurea; Hypericum Perforatum; Ledum Palustre Twig; Matricaria Recutita; Ruta Graveolens Flowering Top; Silicon Dioxide; Strychnos Ignatii Seed
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
  • Dental - Administration to a tooth or teeth.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Usage Information
Adults and children over 6 years of age: Shake well. Spray 4 times per application under the tongue. Repeat 3-4 times per day or as directed by your doctor. Consult a healthcare professional for use in children under 6 years of age. Adults and children over the age of 6 years: Wash hands. Apply to the gum at the surgical or affected area with a cotton swab. Allow gel to dissolve. Do not eat or drink for 20 minutes after application. Apply 4 times per day or as directed by a dental professional. Consult your healthcare professional for use in children under 6 years of age. Adults and children over the age of 6 years: Shake well. Use 3/4 tablespoon (10 ml) per application 3 times a day. Swish in the mouth for 1-2 minutes and then spit out. Do not swallow. Refrain from eating or drinking for at least 20 minutes after use. Consult your healthcare professional for use in children under 6 years of age.

Regulatory & Marketing

Labeler Name
Stellalife, 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
01-08-2021
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 69685-112-01 identifies a specific commercial package of 1 bottle, pump in 1 box / 30 ml in 1 bottle, pump of Stellalife Vega Oral Care Gel, a human over the counter drug labeled by Stellalife, Inc.. This gel is formulated for dental; topical use and contains arnica montana; calcium sulfide; calendula officinalis flowering top; delphinium staphisagria seed; echinacea angustifolia; echinacea purpurea; hypericum perforatum; ledum palustre twig; matricaria recutita; ruta graveolens flowering top; silicon dioxide; strychnos ignatii seed 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 Stellalife, Inc. on January 08, 2021. The current certification is valid through December 31, 2026.

How is this Stellalife, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69685011201. 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)
69685-112-01
11-Digit CMS (5-4-2)
69685-0112-01

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