Bactex Spray
NDC 83027-0047

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 83027-0047?
  4. Bactex Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Bactex (aloe, hydrastis canadensis, allium sativum, anthracinum, bacillus tetani (clostridium tetani), brucella abortus, colibacillinum cum natrum muriaticum, klebsiella pneumoniae, mycoplasma pneumoniae, pneumococcinum, proteus (vulgaris) pseudomonas aeruginosa, staphylococcus aureus, streptococcus viridans, staphysagria, eucalyptol, pyrogenium, lac caninum, lac vaccinum, pertussinum, bacillus cereus, clostridium perfringens, coxiella burnetii (q fever), rickettsia nosode, serratia marcescens) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Nutritional Specialties, Inc.. This medication is typically used as a allergens [cs]. It is supplied as a spray for oral administration. This product entry covers the primary NDC 83027-0047 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
83027-0047
Proprietary Name:
Bactex
Non-Proprietary Name: [1]
Aloe, Hydrastis Canadensis, Allium Sativum, Anthracinum, Bacillus Tetani (clostridium Tetani), Brucella Abortus, Colibacillinum Cum Natrum Muriaticum, Klebsiella Pneumoniae, Mycoplasma Pneumoniae, Pneumococcinum, Proteus (vulgaris) Pseudomonas Aeruginosa, Staphylococcus Aureus, Streptococcus Viridans, Staphysagria, Eucalyptol, Pyrogenium, Lac Caninum, Lac Vaccinum, Pertussinum, Bacillus Cereus, Clostridium Perfringens, Coxiella Burnetii (q Fever), Rickettsia Nosode, Serratia Marcescens
Substance Name: [2]
Aloe; Bacillus Anthracis Immunoserum Rabbit; Bacillus Cereus; Brucella Abortus; Canis Lupus Familiaris Milk; Clostridium Perfringens; Clostridium Tetani; Cow Milk; Coxiella Burnetii; Delphinium Staphisagria Seed; Escherichia Coli; Eucalyptol; Garlic; Goldenseal; Human Sputum, Bordetella Pertussis Infected; Klebsiella Pneumoniae; Mycoplasma Pneumoniae; Proteus Vulgaris; Pseudomonas Aeruginosa; Rancid Beef; Rickettsia Prowazekii; Serratia Marcescens; Staphylococcus Aureus; Streptococcus Pneumoniae; 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:
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 Name: [5]
Nutritional Specialties, Inc.
Labeler Code:
83027
Product Label ID:
c6055c02-a365-4adf-9d3a-47d717c4c93d
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
09-15-2023
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 83027-0047?

The NDC code 83027-0047 is assigned by the FDA to the product Bactex. It is commonly known by its generic name, aloe, hydrastis canadensis, allium sativum, anthracinum, bacillus tetani (clostridium tetani), brucella abortus, colibacillinum cum natrum muriaticum, klebsiella pneumoniae, mycoplasma pneumoniae, pneumococcinum, proteus (vulgaris) pseudomonas aeruginosa, staphylococcus aureus, streptococcus viridans, staphysagria, eucalyptol, pyrogenium, lac caninum, lac vaccinum, pertussinum, bacillus cereus, clostridium perfringens, coxiella burnetii (q fever), rickettsia nosode, serratia marcescens. 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: 83027-0047-1. 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.
  • ALOE 6 [hp_X]/mL - A plant genus of the family ASPHODELACEAE which is used medicinally. It contains anthraquinone glycosides such as aloin-emodin or aloe-emodin (EMODIN).
  • BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 16 [hp_X]/mL
  • BACILLUS CEREUS 18 [hp_C]/mL - A species of rod-shaped bacteria that is a common soil saprophyte. Its spores are widespread and multiplication has been observed chiefly in foods. Contamination may lead to food poisoning.
  • BRUCELLA ABORTUS 16 [hp_X]/mL - A species of the genus BRUCELLA whose natural hosts are cattle and other bovidae. Abortion and placentitis are frequently produced in the pregnant animal. Other mammals, including humans, may be infected.
  • CANIS LUPUS FAMILIARIS MILK 30 [hp_X]/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.
  • CLOSTRIDIUM TETANI 16 [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.
  • COW MILK 30 [hp_X]/mL - The off-white liquid secreted by the mammary glands of humans and other mammals. It contains proteins, sugar, lipids, vitamins, and minerals.
  • COXIELLA BURNETII 18 [hp_C]/mL - A species of gram-negative bacteria that grows preferentially in the vacuoles of the host cell. It is the etiological agent of Q FEVER.
  • DELPHINIUM STAPHISAGRIA SEED 16 [hp_X]/mL
  • 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.
  • EUCALYPTOL 20 [hp_X]/mL - A monoterpene and cyclohexanol derivative that is the major component of EUCALYPTUS OIL. It is used in mouthwash, insect repellent, and as a cough suppressant, and also is widely used as a flavoring agent and solvent. It has antimicrobial properties.
  • GARLIC 12 [hp_X]/mL - A species of Allium used as a spice (SPICES) and traditional remedy. It contains alliin lyase and alliin, which is converted by alliin lyase to allicin, the pungent ingredient responsible for the aroma of fresh cut garlic.
  • GOLDENSEAL 6 [hp_X]/mL
  • HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED 30 [hp_X]/mL
  • KLEBSIELLA PNEUMONIAE 16 [hp_Q]/mL - Gram-negative, non-motile, capsulated, gas-producing rods found widely in nature and associated with urinary and respiratory infections in humans.
  • MYCOPLASMA PNEUMONIAE 16 [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.
  • 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.
  • PSEUDOMONAS AERUGINOSA 16 [hp_X]/mL - A species of gram-negative, aerobic, rod-shaped bacteria commonly isolated from clinical specimens (wound, burn, and urinary tract infections). It is also found widely distributed in soil and water. P. aeruginosa is a major agent of nosocomial infection.
  • RANCID BEEF 20 [hp_X]/mL
  • RICKETTSIA PROWAZEKII 18 [hp_C]/mL - A species of gram-negative, aerobic bacteria that is the etiologic agent of epidemic typhus fever acquired through contact with lice (TYPHUS, EPIDEMIC LOUSE-BORNE) as well as Brill's disease.
  • SERRATIA MARCESCENS 18 [hp_C]/mL - A species of gram-negative, facultatively anaerobic, rod-shaped bacteria found in soil, water, food, and clinical specimens. It is a prominent opportunistic pathogen for hospitalized patients.
  • STAPHYLOCOCCUS AUREUS 16 [hp_X]/mL - 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 PNEUMONIAE 16 [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.
  • STREPTOCOCCUS VIRIDANS GROUP 16 [hp_X]/mL

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".