Stellalife Vega Oral Care Gel
NDC 69685-112

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69685-112?
  5. Stellalife Vega Oral Care Gel Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes

Product Information

Stellalife Vega Oral Care Gel (gel) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Stellalife, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a yellow gel for dental; topical administration. This product entry covers the primary NDC 69685-112 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
69685-112
Proprietary Name:
Stellalife Vega Oral Care Gel
Non-Proprietary Name: [1]
Gel
Substance Name: [2]
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
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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(s): [4]
  • 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.

Labeler & Regulatory Data

Labeler Name: [5]
Stellalife, Inc.
Labeler Code:
69685
Product Label ID:
b8ba495e-2cfe-092c-e053-2995a90a3fd3
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
01-08-2021
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
YELLOW (C48330)
Flavor(s):

Code Structure Chart

Product Details

What is NDC 69685-112?

The NDC code 69685-112 is assigned by the FDA to the product Stellalife Vega Oral Care Gel. It is commonly known by its generic name, gel. This pharmaceutical product is labeled by Stellalife, Inc. and is currently categorized as listed product. The medication is a gel administered via dental; topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 69685-112-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".