Bm Tooth Remineralization Globule
NDC 85816-6010

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 85816-6010?
  5. Bm Tooth Remineralization Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes

Product Information

Bm Tooth Remineralization (calc phos, calc fluor, silicea) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Bm Private Limited. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white globule for oral administration. This product entry covers the primary NDC 85816-6010 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
85816-6010
Proprietary Name:
Bm Tooth Remineralization
Non-Proprietary Name: [1]
Calc Phos, Calc Fluor, Silicea
Substance Name: [2]
Silicon Dioxide; Tribasic Calcium Phosphate; Calcium Fluoride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Globule - Also called pellets or pilules, are made of pure sucrose, lactose, or other polysaccharides. They are formed into small globular masses of various sizes, and are medicated by placing them in a vial and adding the liquid drug attenuation in the proportion not less than one percent (v/w). After shaking, the medicated globules are dried at temperatures not to exceed 40 degrees Centigrade.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Bm Private Limited
Labeler Code:
85816
Product Label ID:
5331dc40-2ac8-5fce-e063-6394a90a5875
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
01-01-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
90 MM
Score:
1

Code Structure Chart

Product Details

What is NDC 85816-6010?

The NDC code 85816-6010 is assigned by the FDA to the product Bm Tooth Remineralization. It is commonly known by its generic name, calc phos, calc fluor, silicea. This pharmaceutical product is labeled by Bm Private Limited and is currently categorized as listed product. The medication is a globule administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 85816-6010-1, 85816-6010-2. 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?

Indications: See the leaflet enclosed for detail.

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.
  • SILICON DIOXIDE 12 [hp_X]/g - Transparent, tasteless crystals found in nature as agate, amethyst, chalcedony, cristobalite, flint, sand, QUARTZ, and tridymite. The compound is insoluble in water or acids except hydrofluoric acid.
  • TRIBASIC CALCIUM PHOSPHATE 12 [hp_X]/g
  • CALCIUM FLUORIDE 12 [hp_X]/g - Calcium fluoride. Occurring in nature as the mineral fluorite or fluorspar. It is the primary source of fluorine and its compounds. Pure calcium fluoride is used as a catalyst in dehydration and dehydrogenation and is used to fluoridate drinking water. (From Merck Index, 11th ed)

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".