Biotox Bac Liquid
NDC 50181-0078

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 50181-0078?
  4. Biotox Bac 3 Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Biotox Bac (mycoplasma pneumoniae, proteus (vulgaris), candida albicans, colibacillinum cum natrum muriaticum, mycobacterium paratuberculosis, pasteurellosis (pasteurella multocida), pneumococcinum, thuja occidentalis, mycobacterium avium paratuberculosis, phytolacca decandra, legionella pneumophila, shigella sonnei) is a UNAPPROVED HOMEOPATHIC-approved product labeled by The Wellness Center For Research And Education, Inc.. This medication is typically used as a allergens [cs]. It is supplied as a liquid for oral administration. This product entry covers the primary NDC 50181-0078 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50181-0078
Proprietary Name:
Biotox Bac 3
Non-Proprietary Name: [1]
Mycoplasma Pneumoniae, Proteus (vulgaris), Candida Albicans, Colibacillinum Cum Natrum Muriaticum, Mycobacterium Paratuberculosis, Pasteurellosis (pasteurella Multocida), Pneumococcinum, Thuja Occidentalis, Mycobacterium Avium Paratuberculosis, Phytolacca Decandra, Legionella Pneumophila, Shigella Sonnei
Substance Name: [2]
Candida Albicans; Escherichia Coli; Legionella Pneumophila; Mycobacterium Avium Subsp. Paratuberculosis; Mycoplasma Pneumoniae; Pasteurella Multocida; Phytolacca Americana Root; Proteus Inconstans; Shigella Sonnei; Streptococcus Pneumoniae; Thuja Occidentalis Leafy Twig
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:
29f1cba2-0bb6-43bf-a630-afc8fcb1ec81
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
11-08-2021
End Marketing Date: [10]
12-09-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 50181-0078?

The NDC code 50181-0078 is assigned by the FDA to the product Biotox Bac 3. It is commonly known by its generic name, mycoplasma pneumoniae, proteus (vulgaris), candida albicans, colibacillinum cum natrum muriaticum, mycobacterium paratuberculosis, pasteurellosis (pasteurella multocida), pneumococcinum, thuja occidentalis, mycobacterium avium paratuberculosis, phytolacca decandra, legionella pneumophila, shigella sonnei. 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: 50181-0078-1. 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 temporary relief of fever and chills. Promotes a productive wet cough and the coughing up of phlegm. expectorant. Helps relieve the presence of mucus in the stool and loose stools.  For temporary relief of fever and chills. Promotes a productive wet cough and the coughing up of phlegm. expectorant. Helps relieve the presence of mucus in the stool 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.
  • CANDIDA ALBICANS 15 [hp_X]/mL - A unicellular budding fungus which is the principal pathogenic species causing CANDIDIASIS (moniliasis).
  • ESCHERICHIA COLI 15 [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.
  • LEGIONELLA PNEUMOPHILA 15 [hp_C]/mL - A species of gram-negative, aerobic bacteria that is the causative agent of LEGIONNAIRES' DISEASE. It has been isolated from numerous environmental sites as well as from human lung tissue, respiratory secretions, and blood.
  • MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS 15 [hp_X]/mL - A subspecies of gram-positive, aerobic bacteria. It is the etiologic agent of Johne's disease (PARATUBERCULOSIS), a chronic GASTROENTERITIS in RUMINANTS.
  • MYCOPLASMA PNEUMONIAE 9 [hp_X]/mL - Short filamentous organism of the genus Mycoplasma, which binds firmly to the cells of the respiratory epithelium. It is one of the etiologic agents of non-viral primary atypical pneumonia in man.
  • PASTEURELLA MULTOCIDA 15 [hp_X]/mL - A species of gram-negative, facultatively anaerobic, rod-shaped bacteria normally found in the flora of the mouth and respiratory tract of animals and birds. It causes shipping fever (see PASTEURELLOSIS, PNEUMONIC); HEMORRHAGIC BACTEREMIA; and intestinal disease in animals. In humans, disease usually arises from a wound infection following a bite or scratch from domesticated animals.
  • PHYTOLACCA AMERICANA ROOT 6 [hp_C]/mL
  • PROTEUS INCONSTANS 12 [hp_X]/mL
  • SHIGELLA SONNEI 15 [hp_C]/mL - A lactose-fermenting bacterium causing dysentery.
  • STREPTOCOCCUS PNEUMONIAE 15 [hp_X]/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.
  • THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X]/mL

Which are the associated UNII Codes?

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

  • MYCOPLASMA PNEUMONIAE (UNII: JQE470FAD0)
  • MYCOPLASMA PNEUMONIAE (UNII: JQE470FAD0) (Active Moiety)
  • PROTEUS INCONSTANS (UNII: UTX536WN6N)
  • PROTEUS INCONSTANS (UNII: UTX536WN6N) (Active Moiety)
  • CANDIDA ALBICANS (UNII: 4D7G21HDBC)
  • CANDIDA ALBICANS (UNII: 4D7G21HDBC) (Active Moiety)
  • ESCHERICHIA COLI (UNII: 514B9K0L10)
  • ESCHERICHIA COLI (UNII: 514B9K0L10) (Active Moiety)
  • MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS (UNII: XH0F4IP2RX)
  • MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS (UNII: XH0F4IP2RX) (Active Moiety)
  • PASTEURELLA MULTOCIDA (UNII: IX56B2GQX6)
  • PASTEURELLA MULTOCIDA (UNII: IX56B2GQX6) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2)
  • STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (Active Moiety)
  • THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397)
  • THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (Active Moiety)
  • PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
  • PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (Active Moiety)
  • LEGIONELLA PNEUMOPHILA (UNII: TJR6ZFY0F0)
  • LEGIONELLA PNEUMOPHILA (UNII: TJR6ZFY0F0) (Active Moiety)
  • SHIGELLA SONNEI (UNII: OO358E3009)
  • SHIGELLA SONNEI (UNII: OO358E3009) (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:

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 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".