Amalgam Liquid
NDC 63083-6003

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 63083-6003?
  4. Amalgam 6003 Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Amalgam is a UNAPPROVED HOMEOPATHIC-approved product labeled by Professional Complementary Health Formulas. This medication is typically used as a allergens [cs]. It is supplied as a liquid for oral administration. This product entry covers the primary NDC 63083-6003 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
63083-6003
Proprietary Name:
Amalgam 6003
Non-Proprietary Name: [1]
Amalgam
Substance Name: [2]
Bos Taurus Bone; Bos Taurus Gingiva; Epichlorohydrin; Fluorine; Gold; Isatis Tinctoria Root; Mercurius Solubilis; Nickel; Palladium; Platinum; Silicon Dioxide; Silver; Sodium Fluoride; Tilletia Caries; Titanium; Treponema Denticola; Xanthan Gum; Zinc Cation
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Professional Complementary Health Formulas
Labeler Code:
63083
Product Label ID:
1af74f69-a23a-45a2-a20e-92bf8b0ccb22
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
08-15-1984
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 63083-6003?

The NDC code 63083-6003 is assigned by the FDA to the product Amalgam 6003. This pharmaceutical product is labeled by Professional Complementary Health Formulas and is currently categorized as listed product. The medication is a liquid administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 63083-6003-2. 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?

For the temporary relief of swollen, red, or tender gums, occasional bad breath, minor toothache, occasional headache, irritability, or fatigue due to sensitivity to or exposure to oral/dental materials.*

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.
  • BOS TAURUS BONE 30 [hp_X]/59mL
  • BOS TAURUS GINGIVA 30 [hp_X]/59mL
  • EPICHLOROHYDRIN 30 [hp_X]/59mL - A chlorinated epoxy compound used as an industrial solvent. It is a strong skin irritant and carcinogen.
  • FLUORINE 30 [hp_X]/59mL - A nonmetallic, diatomic gas that is a trace element and member of the halogen family. It is used in dentistry as fluoride (FLUORIDES) to prevent dental caries.
  • GOLD 30 [hp_X]/59mL - A yellow metallic element with the atomic symbol Au, atomic number 79, and atomic weight 197. It is used in jewelry, goldplating of other metals, as currency, and in dental restoration. Many of its clinical applications, such as ANTIRHEUMATIC AGENTS, are in the form of its salts.
  • ISATIS TINCTORIA ROOT 30 [hp_X]/59mL
  • MERCURIUS SOLUBILIS 30 [hp_X]/59mL
  • NICKEL 30 [hp_X]/59mL - A trace element with the atomic symbol Ni, atomic number 28, and atomic weight 58.69. It is a cofactor of the enzyme UREASE.
  • PALLADIUM 30 [hp_X]/59mL - A chemical element having an atomic weight of 106.4, atomic number of 46, and the symbol Pd. It is a white, ductile metal resembling platinum, and following it in abundance and importance of applications. It is used in dentistry in the form of gold, silver, and copper alloys.
  • PLATINUM 30 [hp_X]/59mL - A heavy, soft, whitish metal, resembling tin, with atomic number 78, atomic weight 195.084, symbol Pt. It is used in manufacturing equipment for laboratory and industrial use. It occurs as a black powder (platinum black) and as a spongy substance (spongy platinum) and may have been known in Pliny's time as alutiae.
  • SILICON DIOXIDE 30 [hp_X]/59mL - 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.
  • SILVER 30 [hp_X]/59mL - An element with the atomic symbol Ag, atomic number 47, and atomic weight 107.87. It is a soft metal that is used medically in surgical instruments, dental prostheses, and alloys. Long-continued use of silver salts can lead to a form of poisoning known as ARGYRIA.
  • SODIUM FLUORIDE 30 [hp_X]/59mL - A source of inorganic fluoride which is used topically to prevent dental caries.
  • TILLETIA CARIES 30 [hp_X]/59mL
  • TITANIUM 30 [hp_X]/59mL - A dark-gray, metallic element of widespread distribution but occurring in small amounts with atomic number, 22, atomic weight, 47.867 and symbol, Ti; specific gravity, 4.5; used for fixation of fractures.
  • TREPONEMA DENTICOLA 30 [hp_X]/59mL - A species of bacteria in the family SPIROCHAETACEAE, frequently isolated from periodontal pockets (PERIODONTAL POCKET).
  • XANTHAN GUM 30 [hp_X]/59mL - a polysaccharide gum derived from Xanthomonas campestris by a pure culture fermentation process
  • ZINC CATION 30 [hp_X]/59mL

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".