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  4. NDC Product Code: 83027-0072 Bowel Sode

NDC 83027-0072 Bowel Sode

Ascaris Lumbricoides,Borrelia Burgdorferi,Botulinum,Colibacillinum Cum Natrum - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 83027-0072?
  4. Bowel Sode Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
83027-0072
Proprietary Name:
Bowel Sode
Non-Proprietary Name: [1]
Ascaris Lumbricoides, Borrelia Burgdorferi, Botulinum, Colibacillinum Cum Natrum Muriaticum, Enterobius Vermicularis, Giardia Lamblia, Helicobacter Pylori, Proteus (vulgaris), Trichinella Spiralis, Enterococcus Faecalis, Taenia Saginatta, Taenia Solium, Adenoviren Nosode, Campylobacter Jejuni, Clostridium Perfringens, Dysentery Bacillus, Clostridium Difficile, Entamoeba Histolytica
Substance Name: [2]
Ascaris Lumbricoides; Borrelia Burgdorferi; Campylobacter Jejuni; Clostridium Botulinum; Clostridium Difficile; Clostridium Perfringens; Entamoeba Histolytica; Enterobius Vermicularis; Enterococcus Faecalis; Escherichia Coli; Giardia Lamblia; Helicobacter Pylori; Human Adenovirus E Serotype 4 Strain Cl-68578 Antigen; Proteus Vulgaris; Shigella Dysenteriae; Taenia Saginata; Taenia Solium; Trichinella Spiralis
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Nutritional Specialties, Inc.
    Labeler Code:
    83027
    Product Label ID:
    caf62710-f8f0-4ca5-b3ac-6bc79af044a5
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    09-15-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 83027-0072?

    The NDC code 83027-0072 is assigned by the FDA to the product Bowel Sode which is a human over the counter drug product labeled by Nutritional Specialties, Inc.. The generic name of Bowel Sode is ascaris lumbricoides, borrelia burgdorferi, botulinum, colibacillinum cum natrum muriaticum, enterobius vermicularis, giardia lamblia, helicobacter pylori, proteus (vulgaris), trichinella spiralis, enterococcus faecalis, taenia saginatta, taenia solium, adenoviren nosode, campylobacter jejuni, clostridium perfringens, dysentery bacillus, clostridium difficile, entamoeba histolytica. The product's dosage form is spray and is administered via oral form. The product is distributed in a single package with assigned NDC code 83027-0072-1 60 ml in 1 bottle, spray . 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 Bowel Sode?

    Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

    What are Bowel Sode 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.
    • ASCARIS LUMBRICOIDES 16 [hp_X]/mL - 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.
    • BORRELIA BURGDORFERI 16 [hp_X]/mL - A specific species of bacteria, part of the BORRELIA BURGDORFERI GROUP, whose common name is Lyme disease spirochete.
    • CAMPYLOBACTER JEJUNI 12 [hp_C]/mL - A species of bacteria that resemble small tightly coiled spirals. Its organisms are known to cause abortion in sheep and fever and enteritis in man and may be associated with enteric diseases of calves, lambs, and other animals.
    • CLOSTRIDIUM BOTULINUM 16 [hp_X]/mL - 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 DIFFICILE 32 [hp_C]/mL
    • CLOSTRIDIUM PERFRINGENS 18 [hp_C]/mL - The most common etiologic agent of GAS GANGRENE. It is differentiable into several distinct types based on the distribution of twelve different toxins.
    • ENTAMOEBA HISTOLYTICA 32 [hp_C]/mL - A species of parasitic protozoa causing ENTAMOEBIASIS and amebic dysentery (DYSENTERY, AMEBIC). Characteristics include a single nucleus containing a small central karyosome and peripheral chromatin that is finely and regularly beaded.
    • ENTEROBIUS VERMICULARIS 16 [hp_X]/mL
    • ENTEROCOCCUS FAECALIS 20 [hp_X]/mL - A species of gram-positive, coccoid bacteria commonly isolated from clinical specimens and the human intestinal tract. Most strains are nonhemolytic.
    • ESCHERICHIA COLI 16 [hp_X]/mL - 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 16 [hp_X]/mL - 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 16 [hp_X]/mL - 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).
    • HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN 12 [hp_C]/mL
    • PROTEUS VULGARIS 16 [hp_X]/mL - A species of gram-negative, facultatively anaerobic, rod-shaped bacteria that occurs in soil, fecal matter, and sewage. It is an opportunistic pathogen and causes cystitis and pyelonephritis.
    • SHIGELLA DYSENTERIAE 18 [hp_C]/mL - A species of gram-negative, facultatively anaerobic, rod-shaped bacteria that is extremely pathogenic and causes severe dysentery. Infection with this organism often leads to ulceration of the intestinal epithelium.
    • TAENIA SAGINATA 8 [hp_C]/mL - Species of tapeworm in the genus TAENIA, that infects cattle. It is acquired by humans through the ingestion of raw or insufficiently cooked beef.
    • TAENIA SOLIUM 8 [hp_C]/mL - Species of tapeworm in the genus TAENIA, that infects swine. It is acquired by humans through the ingestion of cured or undercooked pork.
    • TRICHINELLA SPIRALIS 16 [hp_X]/mL - A parasite of carnivorous mammals that causes TRICHINELLOSIS. It is especially common in rats and in swine fed uncooked garbage. Human infection is initiated by the consumption of raw or insufficiently cooked pork or other meat containing the encysted larvae.

    Which are Bowel Sode UNII Codes?

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

    Which are Bowel Sode 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:

    Which are the Pharmacologic Classes for Bowel Sode?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    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".