Bowel Pathogen Nosode Liquid
NDC 63083-4005

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 63083-4005?
  4. Bowel Pathogen Nosode 4005 Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

Bowel Pathogen Nosode is a UNAPPROVED HOMEOPATHIC-approved product labeled by Professional Complementary Health Formulas. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a liquid for oral administration. This product entry covers the primary NDC 63083-4005 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
63083-4005
Proprietary Name:
Bowel Pathogen Nosode 4005
Non-Proprietary Name: [1]
Bowel Pathogen Nosode
Substance Name: [2]
Amoeba Proteus; Ancylostoma Duodenale; Ascaris Lumbricoides; Blastocystis Hominis; Citrobacter Freundii; Clostridium Botulinum; Clostridium Perfringens; Cryptosporidium Hominis; Diphtherial Respiratory Pseudomembrane Human; Echinococcus Granulosus; Enterococcus Faecium; Escherichia Coli; Giardia Lamblia; Helicobacter Pylori; Necator Americanus; Pheretima Aspergillum
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:
97564c37-a983-4c93-9214-bf51531efb69
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 63083-4005?

The NDC code 63083-4005 is assigned by the FDA to the product Bowel Pathogen Nosode 4005. 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: 63083-4005-2. 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 diarrhea, nausea or vomiting, abdominal pain or cramps, bloating, fatigue, or feelings of discomfort or uneasiness.*

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.
  • AMOEBA PROTEUS 30 [hp_X]/59mL
  • ANCYLOSTOMA DUODENALE 30 [hp_X]/59mL
  • ASCARIS LUMBRICOIDES 30 [hp_X]/59mL - A species of parasitic nematode that is the largest found in the human intestine. Its distribution is worldwide, but it is more prevalent in areas of poor sanitation. Human infection with A. lumbricoides is acquired by swallowing fully embryonated eggs from contaminated soil.
  • BLASTOCYSTIS HOMINIS 30 [hp_X]/59mL - A species of parasitic protozoa found in the intestines of humans and other primates. It was classified as a yeast in 1912. Over the years, questions arose about this designation. In 1967, many physiological and morphological B. hominis characteristics were reported that fit a protozoan classification. Since that time, other papers have corroborated this work and the organism is now recognized as a protozoan parasite of humans causing intestinal disease with potentially disabling symptoms.
  • CITROBACTER FREUNDII 30 [hp_X]/59mL - A species of gram-negative, facultatively anaerobic, rod-shaped bacteria found in humans and other animals including MAMMALS; BIRDS; REPTILES; and AMPHIBIANS. It has also been isolated from SOIL and WATER as well as from clinical specimens such as URINE; THROAT; SPUTUM; BLOOD; and wound swabs as an opportunistic pathogen.
  • CLOSTRIDIUM BOTULINUM 30 [hp_X]/59mL - A species of anaerobic, gram-positive, rod-shaped bacteria in the family Clostridiaceae that produces proteins with characteristic neurotoxicity. It is the etiologic agent of BOTULISM in humans, wild fowl, HORSES; and CATTLE. Seven subtypes (sometimes called antigenic types, or strains) exist, each producing a different botulinum toxin (BOTULINUM TOXINS). The organism and its spores are widely distributed in nature.
  • CLOSTRIDIUM PERFRINGENS 30 [hp_X]/59mL - The most common etiologic agent of GAS GANGRENE. It is differentiable into several distinct types based on the distribution of twelve different toxins.
  • CRYPTOSPORIDIUM HOMINIS 30 [hp_X]/59mL
  • DIPHTHERIAL RESPIRATORY PSEUDOMEMBRANE HUMAN 30 [hp_X]/59mL
  • ECHINOCOCCUS GRANULOSUS 30 [hp_X]/59mL - A species of hydatid tapeworm (class CESTODA) in the family Taeniidae, whose adult form infects the DIGESTIVE TRACT of DOGS, other canines, and CATS. The larval form infects SHEEP; PIGS; HORSES; and may infect humans, where it migrates to various organs and forms permanent HYDATID CYSTS.
  • ENTEROCOCCUS FAECIUM 30 [hp_X]/59mL - A species of gram-positive, coccoid bacteria whose organisms are normal flora of the intestinal tract. Unlike ENTEROCOCCUS FAECALIS, this species may produce an alpha-hemolytic reaction on blood agar and is unable to utilize pyruvic acid as an energy source.
  • ESCHERICHIA COLI 30 [hp_X]/59mL - A species of gram-negative, facultatively anaerobic, rod-shaped bacteria (GRAM-NEGATIVE FACULTATIVELY ANAEROBIC RODS) commonly found in the lower part of the intestine of warm-blooded animals. It is usually nonpathogenic, but some strains are known to produce DIARRHEA and pyogenic infections. Pathogenic strains (virotypes) are classified by their specific pathogenic mechanisms such as toxins (ENTEROTOXIGENIC ESCHERICHIA COLI), etc.
  • GIARDIA LAMBLIA 30 [hp_X]/59mL - A species of parasitic EUKARYOTES that attaches itself to the intestinal mucosa and feeds on mucous secretions. The organism is roughly pear-shaped and motility is somewhat erratic, with a slow oscillation about the long axis.
  • HELICOBACTER PYLORI 30 [hp_X]/59mL - A spiral bacterium active as a human gastric pathogen. It is a gram-negative, urease-positive, curved or slightly spiral organism initially isolated in 1982 from patients with lesions of gastritis or peptic ulcers in Western Australia. Helicobacter pylori was originally classified in the genus CAMPYLOBACTER, but RNA sequencing, cellular fatty acid profiles, growth patterns, and other taxonomic characteristics indicate that the micro-organism should be included in the genus HELICOBACTER. It has been officially transferred to Helicobacter gen. nov. (see Int J Syst Bacteriol 1989 Oct;39(4):297-405).
  • NECATOR AMERICANUS 30 [hp_X]/59mL - A common parasite of humans in the moist tropics and subtropics. These organisms attach to villi in the small intestine and suck blood causing diarrhea, anorexia, and anemia.
  • PHERETIMA ASPERGILLUM 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".