Mineffect Eye Drops Solution/ Drops
NDC 81488-001

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 81488-001?
  4. Mineffect Eye Drops Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

Mineffect Eye Drops (alumina silicata, calcarea fluorica, ferrum metallicum, ferrum phosphoricum, natrum muriaticum, phosphorus, sulphur, titanium metallicum, zincum metallicum) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Kadesh Incoporation Co,ltd. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a solution/ drops for ophthalmic administration. This product entry covers the primary NDC 81488-001 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
81488-001
Proprietary Name:
Mineffect Eye Drops
Non-Proprietary Name: [1]
Alumina Silicata, Calcarea Fluorica, Ferrum Metallicum, Ferrum Phosphoricum, Natrum Muriaticum, Phosphorus, Sulphur, Titanium Metallicum, Zincum Metallicum
Substance Name: [2]
Calcium Fluoride; Ferrosoferric Phosphate; Iron; Kaolin; Phosphorus; Sodium Chloride; Sulfur; Titanium; Zinc
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
Ophthalmic - Administration to the external eye.

Labeler & Regulatory Data

Labeler Name: [5]
Kadesh Incoporation Co,ltd
Labeler Code:
81488
Product Label ID:
e2259f58-3043-4af3-918d-d4403757aa1f
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
02-01-2021
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 81488-001?

The NDC code 81488-001 is assigned by the FDA to the product Mineffect Eye Drops. It is commonly known by its generic name, alumina silicata, calcarea fluorica, ferrum metallicum, ferrum phosphoricum, natrum muriaticum, phosphorus, sulphur, titanium metallicum, zincum metallicum. This pharmaceutical product is labeled by Kadesh Incoporation Co,ltd and is currently categorized as listed product. The medication is a solution/ drops administered via ophthalmic route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 81488-001-15. 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?

Instill 1 or 2 drops in the affected eye(s) as needed.

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.
  • CALCIUM FLUORIDE 6 [hp_X]/15mL - 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)
  • FERROSOFERRIC PHOSPHATE 7 [hp_X]/15mL
  • IRON 7 [hp_X]/15mL - A metallic element with atomic symbol Fe, atomic number 26, and atomic weight 55.85. It is an essential constituent of HEMOGLOBINS; CYTOCHROMES; and IRON-BINDING PROTEINS. It plays a role in cellular redox reactions and in the transport of OXYGEN.
  • KAOLIN 5 [hp_X]/15mL - The most common mineral of a group of hydrated aluminum silicates, approximately H2Al2Si2O8-H2O. It is prepared for pharmaceutical and medicinal purposes by levigating with water to remove sand, etc. (From Merck Index, 11th ed) The name is derived from Kao-ling (Chinese: high ridge), the original site. (From Grant & Hackh's Chemical Dictionary, 5th ed)
  • PHOSPHORUS 6 [hp_X]/15mL - A non-metal element that has the atomic symbol P, atomic number 15, and atomic weight 31. It is an essential element that takes part in a broad variety of biochemical reactions.
  • SODIUM CHLORIDE 4 [hp_X]/15mL - A ubiquitous sodium salt that is commonly used to season food.
  • SULFUR 4 [hp_X]/15mL - An element that is a member of the chalcogen family. It has an atomic symbol S, atomic number 16, and atomic weight [32.059; 32.076]. It is found in the amino acids cysteine and methionine.
  • TITANIUM 7 [hp_X]/15mL - 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.
  • ZINC 8 [hp_X]/15mL - A metallic element of atomic number 30 and atomic weight 65.38. It is a necessary trace element in the diet, forming an essential part of many enzymes, and playing an important role in protein synthesis and in cell division. Zinc deficiency is associated with ANEMIA, short stature, HYPOGONADISM, impaired WOUND HEALING, and geophagia. It is known by the symbol Zn.

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".