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  4. NDC Product Code: 75053-0009 Oxaltem

NDC 75053-0009 Oxaltem

Berberis Vulgaris,Oxalicum Acidum,Sanguinaria Canadensis,Chimaphila Umbellata,Calcarea - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 75053-0009?
  4. Oxaltem Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
75053-0009
Proprietary Name:
Oxaltem
Non-Proprietary Name: [1]
Berberis Vulgaris, Oxalicum Acidum, Sanguinaria Canadensis, Chimaphila Umbellata, Calcarea Fluorica, Calcarea Silicata, Uricum Acidum, Calcarea Phosphorica, Parathormonum, Pyridoxinum Hydrochloricum
Substance Name: [2]
Berberis Vulgaris Root Bark; Calcium Fluoride; Calcium Silicate; Chimaphila Umbellata Whole; Oxalic Acid; Parathyroid Hormone; Pyridoxine Hydrochloride; Sanguinaria Canadensis Whole; Tribasic Calcium Phosphate; Uric Acid
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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 Name: [5]
    Nucleic Products, Llc
    Labeler Code:
    75053
    Product Label ID:
    ab35fadf-5213-486b-b313-e676420efff7
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    01-31-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 75053-0009?

    The NDC code 75053-0009 is assigned by the FDA to the product Oxaltem which is a human over the counter drug product labeled by Nucleic Products, Llc. The generic name of Oxaltem is berberis vulgaris, oxalicum acidum, sanguinaria canadensis, chimaphila umbellata, calcarea fluorica, calcarea silicata, uricum acidum, calcarea phosphorica, parathormonum, pyridoxinum hydrochloricum. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 75053-0009-1 118 ml in 1 bottle, dropper . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Oxaltem?

    Homeopathic medicine for the regulation of oxalate deposition and related dysfunctions of drainage.Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated. Homeopathic medicine for the regulation of oxalate deposition and related dysfunctions of drainage.Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.

    What are Oxaltem Active Ingredients?

    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.
    • BERBERIS VULGARIS ROOT BARK 6 [hp_X]/mL
    • CALCIUM FLUORIDE 12 [hp_X]/mL - 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)
    • CALCIUM SILICATE 12 [hp_X]/mL
    • CHIMAPHILA UMBELLATA WHOLE 9 [hp_X]/mL
    • OXALIC ACID 6 [hp_X]/mL - A strong dicarboxylic acid occurring in many plants and vegetables. It is produced in the body by metabolism of glyoxylic acid or ascorbic acid. It is not metabolized but excreted in the urine. It is used as an analytical reagent and general reducing agent.
    • PARATHYROID HORMONE 9 [hp_C]/mL - A polypeptide hormone (84 amino acid residues) secreted by the PARATHYROID GLANDS which performs the essential role of maintaining intracellular CALCIUM levels in the body. Parathyroid hormone increases intracellular calcium by promoting the release of CALCIUM from BONE, increases the intestinal absorption of calcium, increases the renal tubular reabsorption of calcium, and increases the renal excretion of phosphates.
    • PYRIDOXINE HYDROCHLORIDE 12 [hp_C]/mL - The 4-methanol form of VITAMIN B 6 which is converted to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).
    • SANGUINARIA CANADENSIS WHOLE 9 [hp_X]/mL
    • TRIBASIC CALCIUM PHOSPHATE 6 [hp_C]/mL
    • URIC ACID 12 [hp_X]/mL - An oxidation product, via XANTHINE OXIDASE, of oxypurines such as XANTHINE and HYPOXANTHINE. It is the final oxidation product of purine catabolism in humans and primates, whereas in most other mammals URATE OXIDASE further oxidizes it to ALLANTOIN.

    Which are Oxaltem UNII Codes?

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

    Which are Oxaltem Inactive Ingredients 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 Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".