Biotox Bac Liquid
NDC 50181-0077

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 50181-0077?
  4. Biotox Bac 2 Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

Biotox Bac (bacillus tetani, chlamydia trachomatis, streptococcus viridans, meningococcus nosode, phytolacca decandra, pneumococcinum, clostridium perfringens, dysentery bacillus, enterococcus faecalis, listeria monocytogenes, streptococcus agalactiae, streptococcus dysgalactiae, streptococcus mutans, streptococcus bovis, streptococcus uberis) is a UNAPPROVED HOMEOPATHIC-approved product labeled by The Wellness Center For Research And Education, Inc.. 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 50181-0077 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50181-0077
Proprietary Name:
Biotox Bac 2
Non-Proprietary Name: [1]
Bacillus Tetani, Chlamydia Trachomatis, Streptococcus Viridans, Meningococcus Nosode, Phytolacca Decandra, Pneumococcinum, Clostridium Perfringens, Dysentery Bacillus, Enterococcus Faecalis, Listeria Monocytogenes, Streptococcus Agalactiae, Streptococcus Dysgalactiae, Streptococcus Mutans, Streptococcus Bovis, Streptococcus Uberis
Substance Name: [2]
Chlamydia Trachomatis; Clostridium Perfringens; Clostridium Tetani; Enterococcus Faecalis; Listeria Monocytogenes; Neisseria Meningitidis; Phytolacca Americana Root; Shigella Dysenteriae; Streptococcus Agalactiae; Streptococcus Dysgalactiae; Streptococcus Equinus; Streptococcus Mutans; Streptococcus Pneumoniae; Streptococcus Uberis; Streptococcus Viridans Group
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]
The Wellness Center For Research And Education, Inc.
Labeler Code:
50181
Product Label ID:
1554cd2d-e064-46f1-a635-2c80191a7b9e
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
10-04-2021
End Marketing Date: [10]
10-26-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 50181-0077?

The NDC code 50181-0077 is assigned by the FDA to the product Biotox Bac 2. It is commonly known by its generic name, bacillus tetani, chlamydia trachomatis, streptococcus viridans, meningococcus nosode, phytolacca decandra, pneumococcinum, clostridium perfringens, dysentery bacillus, enterococcus faecalis, listeria monocytogenes, streptococcus agalactiae, streptococcus dysgalactiae, streptococcus mutans, streptococcus bovis, streptococcus uberis. This pharmaceutical product is labeled by The Wellness Center For Research And Education, Inc. 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: 50181-0077-1. 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?

For the temporary relief of fever, sore throat, fatigue, pain and loose stools.  For the temporary relief of fever, sore throat, fatigue, pain and loose stools.

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.
  • CHLAMYDIA TRACHOMATIS 15 [hp_X]/mL - Type species of CHLAMYDIA causing a variety of ocular and urogenital diseases.
  • CLOSTRIDIUM PERFRINGENS 15 [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.
  • CLOSTRIDIUM TETANI 15 [hp_X]/mL - The cause of TETANUS in humans and domestic animals. It is a common inhabitant of human and horse intestines as well as soil. Two components make up its potent exotoxin activity, a neurotoxin and a hemolytic toxin.
  • ENTEROCOCCUS FAECALIS 15 [hp_C]/mL - A species of gram-positive, coccoid bacteria commonly isolated from clinical specimens and the human intestinal tract. Most strains are nonhemolytic.
  • LISTERIA MONOCYTOGENES 15 [hp_C]/mL - A species of gram-positive, rod-shaped bacteria widely distributed in nature. It has been isolated from sewage, soil, silage, and from feces of healthy animals and man. Infection with this bacterium leads to encephalitis, meningitis, endocarditis, and abortion.
  • NEISSERIA MENINGITIDIS 27 [hp_X]/mL - A species of gram-negative, aerobic BACTERIA. It is a commensal and pathogen only of humans, and can be carried asymptomatically in the NASOPHARYNX. When found in cerebrospinal fluid it is the causative agent of cerebrospinal meningitis (MENINGITIS, MENINGOCOCCAL). It is also found in venereal discharges and blood. There are at least 13 serogroups based on antigenic differences in the capsular polysaccharides; the ones causing most meningitis infections being A, B, C, Y, and W-135. Each serogroup can be further classified by serotype, serosubtype, and immunotype.
  • PHYTOLACCA AMERICANA ROOT 6 [hp_C]/mL
  • SHIGELLA DYSENTERIAE 15 [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.
  • STREPTOCOCCUS AGALACTIAE 15 [hp_C]/mL - A bacterium which causes mastitis in cattle and occasionally in man.
  • STREPTOCOCCUS DYSGALACTIAE 15 [hp_C]/mL
  • STREPTOCOCCUS EQUINUS 32 [hp_C]/mL - A species of gram-positive, coccoid bacteria commonly found in the alimentary tract of cows, sheep, and other ruminants. It occasionally is encountered in cases of human endocarditis. This species is nonhemolytic.
  • STREPTOCOCCUS MUTANS 15 [hp_C]/mL - A polysaccharide-producing species of STREPTOCOCCUS isolated from human dental plaque.
  • STREPTOCOCCUS PNEUMONIAE 12 [hp_C]/mL - A gram-positive organism found in the upper respiratory tract, inflammatory exudates, and various body fluids of normal and/or diseased humans and, rarely, domestic animals.
  • STREPTOCOCCUS UBERIS 32 [hp_C]/mL
  • STREPTOCOCCUS VIRIDANS GROUP 15 [hp_X]/mL

Which are the associated UNII Codes?

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

  • CLOSTRIDIUM TETANI (UNII: 751E8J54VM)
  • CLOSTRIDIUM TETANI (UNII: 751E8J54VM) (Active Moiety)
  • CHLAMYDIA TRACHOMATIS (UNII: T6NI39QU44)
  • CHLAMYDIA TRACHOMATIS (UNII: T6NI39QU44) (Active Moiety)
  • STREPTOCOCCUS VIRIDANS GROUP (UNII: NNV2379HKR)
  • STREPTOCOCCUS VIRIDANS GROUP (UNII: NNV2379HKR) (Active Moiety)
  • NEISSERIA MENINGITIDIS (UNII: V3TP2MD7F3)
  • NEISSERIA MENINGITIDIS (UNII: V3TP2MD7F3) (Active Moiety)
  • PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
  • PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2)
  • STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (Active Moiety)
  • CLOSTRIDIUM PERFRINGENS (UNII: OVP6XX033E)
  • CLOSTRIDIUM PERFRINGENS (UNII: OVP6XX033E) (Active Moiety)
  • SHIGELLA DYSENTERIAE (UNII: 1EP6R5562J)
  • SHIGELLA DYSENTERIAE (UNII: 1EP6R5562J) (Active Moiety)
  • ENTEROCOCCUS FAECALIS (UNII: 15E04LZ9CT)
  • ENTEROCOCCUS FAECALIS (UNII: 15E04LZ9CT) (Active Moiety)
  • LISTERIA MONOCYTOGENES (UNII: 3O44K14A86)
  • LISTERIA MONOCYTOGENES (UNII: 3O44K14A86) (Active Moiety)
  • STREPTOCOCCUS AGALACTIAE (UNII: 2B3763S671)
  • STREPTOCOCCUS AGALACTIAE (UNII: 2B3763S671) (Active Moiety)
  • STREPTOCOCCUS DYSGALACTIAE (UNII: LN0SH02Y5M)
  • STREPTOCOCCUS DYSGALACTIAE (UNII: LN0SH02Y5M) (Active Moiety)
  • STREPTOCOCCUS MUTANS (UNII: 5C7J33MJJ1)
  • STREPTOCOCCUS MUTANS (UNII: 5C7J33MJJ1) (Active Moiety)
  • STREPTOCOCCUS EQUINUS (UNII: R2P4NKP3ZK)
  • STREPTOCOCCUS EQUINUS (UNII: R2P4NKP3ZK) (Active Moiety)
  • STREPTOCOCCUS UBERIS (UNII: O84V4ZK4BX)
  • STREPTOCOCCUS UBERIS (UNII: O84V4ZK4BX) (Active Moiety)

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".