Bowel Sode Spray
NDC 83027-0147

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

Product Information

Bowel Sode (ascaris lumbricoides, borrelia burgdorferi, colibacillinum cum natrum muriaticum, enterobius vermicularis, helicobacter pylori, proteus (vulgaris), trichinella spiralis, enterococcus faecalis, taenia saginatta, taenia solium, adenoviren nosode, campylobacter jejuni, clostridium perfringens, dysentery bacillus, giardia lamblia, clostridium difficile, entamoeba histolytica) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Nutritional Specialties, Inc.. This medication is typically used as a actively acquired immunity [pe]. It is supplied as a spray for oral administration. This product entry covers the primary NDC 83027-0147 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
83027-0147
Proprietary Name:
Bowel Sode
Non-Proprietary Name: [1]
Ascaris Lumbricoides, Borrelia Burgdorferi, Colibacillinum Cum Natrum Muriaticum, Enterobius Vermicularis, Helicobacter Pylori, Proteus (vulgaris), Trichinella Spiralis, Enterococcus Faecalis, Taenia Saginatta, Taenia Solium, Adenoviren Nosode, Campylobacter Jejuni, Clostridium Perfringens, Dysentery Bacillus, Giardia Lamblia, Clostridium Difficile, Entamoeba Histolytica
Substance Name: [2]
Ascaris Lumbricoides; Borrelia Burgdorferi; Campylobacter Jejuni; Clostridioides 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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Code:
83027
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
11-12-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 83027-0147?

The NDC code 83027-0147 is assigned by the FDA to the product Bowel Sode. It is commonly known by its generic name, ascaris lumbricoides, borrelia burgdorferi, colibacillinum cum natrum muriaticum, enterobius vermicularis, helicobacter pylori, proteus (vulgaris), trichinella spiralis, enterococcus faecalis, taenia saginatta, taenia solium, adenoviren nosode, campylobacter jejuni, clostridium perfringens, dysentery bacillus, giardia lamblia, clostridium difficile, entamoeba histolytica. This pharmaceutical product is labeled by Nutritional Specialties, Inc. and is currently categorized as listed product. The medication is a spray administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 83027-0147-1. 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?

• 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 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.
  • 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.
  • CLOSTRIDIOIDES DIFFICILE 32 [hp_C]/mL - A common inhabitant of the colon flora in human infants and sometimes in adults. The type species Clostridioides difficile is formerly known as Clostridium difficile. It is a causative agent for CLOSTRIDIOIDES INFECTIONS and is associated with PSEUDOMEMBRANOUS ENTEROCOLITIS in patients receiving antibiotic therapy.
  • 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 18 [hp_C]/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 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:

Which are the Pharmacologic Classes of this product?

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.

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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".