Low Bacterial Nosode Liquid
NDC 63083-4022
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Low Bacterial 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 63083-4022 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
63083-4022
Proprietary Name:
Low Bacterial Nosode 4022
Non-Proprietary Name: [1]
Low Bacterial Nosode
Substance Name: [2]
Bovine Tuberculin; Diphtherial Respiratory Pseudomembrane Human; Escherichia Coli; Rancid Beef; Salmonella Enterica Enterica Serovar Typhi; Staphylococcus Aureus; Streptococcus Pyogenes
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]
Labeler Code:
63083
Product Label ID:
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 63083-4022?
The NDC code 63083-4022 is assigned by the FDA to the product Low Bacterial Nosode 4022. 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: 63083-4022-2. 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?
Temporarily reduces occasional mild abdominal pain or discomfort, nausea, headache, fatigue, runny nose, chills, cough, congestion, or minor sore throat.*
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.
- BOVINE TUBERCULIN 12 [hp_X]/59mL
- DIPHTHERIAL RESPIRATORY PSEUDOMEMBRANE HUMAN 12 [hp_X]/59mL
- 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.
- RANCID BEEF 12 [hp_X]/59mL
- SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI 12 [hp_X]/59mL
- STAPHYLOCOCCUS AUREUS 12 [hp_X]/59mL - Potentially pathogenic bacteria found in nasal membranes, skin, hair follicles, and perineum of warm-blooded animals. They may cause a wide range of infections and intoxications.
- STREPTOCOCCUS PYOGENES 12 [hp_X]/59mL - A species of gram-positive, coccoid bacteria isolated from skin lesions, blood, inflammatory exudates, and the upper respiratory tract of humans. It is a group A hemolytic Streptococcus that can cause SCARLET FEVER and RHEUMATIC FEVER.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- DIPHTHERIAL RESPIRATORY PSEUDOMEMBRANE HUMAN (UNII: 50SG618FGN)
- DIPHTHERIAL RESPIRATORY PSEUDOMEMBRANE HUMAN (UNII: 50SG618FGN) (Active Moiety)
- STREPTOCOCCUS PYOGENES (UNII: LJ2LP0YL98)
- STREPTOCOCCUS PYOGENES (UNII: LJ2LP0YL98) (Active Moiety)
- RANCID BEEF (UNII: 29SUH5R3HU)
- RANCID BEEF (UNII: 29SUH5R3HU) (Active Moiety)
- SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI (UNII: 760T5R8B3O)
- SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI (UNII: 760T5R8B3O) (Active Moiety)
- STAPHYLOCOCCUS AUREUS (UNII: O478WX4004)
- STAPHYLOCOCCUS AUREUS (UNII: O478WX4004) (Active Moiety)
- BOVINE TUBERCULIN (UNII: HKD62G79N5)
- BOVINE TUBERCULIN (UNII: HKD62G79N5) (Active Moiety)
- ESCHERICHIA COLI (UNII: 514B9K0L10)
- ESCHERICHIA COLI (UNII: 514B9K0L10) (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:
- ALCOHOL (UNII: 3K9958V90M)
- WATER (UNII: 059QF0KO0R)
* Please review the full disclaimer at the bottom of this page.
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".
