Oxaltem Liquid
NDC 75053-0009

View dosage, usage, ingredients, routes, and UNII mappings.
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

Oxaltem (berberis vulgaris, oxalicum acidum, sanguinaria canadensis, chimaphila umbellata, calcarea fluorica, calcarea silicata, uricum acidum, calcarea phosphorica, parathormonum, pyridoxinum hydrochloricum) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Nucleic Products, Llc. This medication is typically used as a analogs/derivatives [chemical/ingredient]. It is supplied as a liquid for oral administration. This product entry covers the primary NDC 75053-0009 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
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]
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.

Marketing Timeline

Start Marketing Date: [9]
01-31-2022
End Marketing Date: [10]
07-26-2028
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 75053-0009?

The NDC code 75053-0009 is assigned by the FDA to the product Oxaltem. It is commonly known by its generic name, berberis vulgaris, oxalicum acidum, sanguinaria canadensis, chimaphila umbellata, calcarea fluorica, calcarea silicata, uricum acidum, calcarea phosphorica, parathormonum, pyridoxinum hydrochloricum. This pharmaceutical product is labeled by Nucleic Products, Llc 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: 75053-0009-1. 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?

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 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.
  • 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 - RN given refers to cpd with unknown MF
  • 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 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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".