Sinus Defense Spray
NDC 83018-0002

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 83018-0002?
  4. Sinus Defense Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Sinus Defense (lac vaccinum, silicea, aspergillus niger, babesia microti, borrelia burgdorferi, candida albicans, candida parapsilosis, chlamydia trachomatis, colibacillinum cum natrum muriaticum, cytomegalovirus nosode, ehrlichia nosode, herpes simplex i and ii nosode, human papilloma nosode, klebsiella pneumoniae, mucor racemosus, mycobacterium paratuberculosis, pneumoccoccinum, staphylococcus aureus, streptococcus viridans, epstein-barr virus nosode, herpes zoster nosode) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Micro Balance Health Products Llc. 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 83018-0002 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
83018-0002
Proprietary Name:
Sinus Defense
Non-Proprietary Name: [1]
Lac Vaccinum, Silicea, Aspergillus Niger, Babesia Microti, Borrelia Burgdorferi, Candida Albicans, Candida Parapsilosis, Chlamydia Trachomatis, Colibacillinum Cum Natrum Muriaticum, Cytomegalovirus Nosode, Ehrlichia Nosode, Herpes Simplex I And Ii Nosode, Human Papilloma Nosode, Klebsiella Pneumoniae, Mucor Racemosus, Mycobacterium Paratuberculosis, Pneumoccoccinum, Staphylococcus Aureus, Streptococcus Viridans, Epstein-barr Virus Nosode, Herpes Zoster Nosode
Substance Name: [2]
Aspergillus Niger Var. Niger; Babesia Microti; Borrelia Burgdorferi; Candida Albicans; Candida Parapsilosis; Chlamydia Trachomatis; Cow Milk; Ehrlichia Canis; Escherichia Coli; Human Herpesvirus 1; Human Herpesvirus 2; Human Herpesvirus 3; Human Herpesvirus 4; Human Herpesvirus 5; Human Papillomavirus; Klebsiella Pneumoniae; Mucor Racemosus; Mycobacterium Avium Subsp. Paratuberculosis; Silicon Dioxide; 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]
Micro Balance Health Products Llc
Labeler Code:
83018
Product Label ID:
9c2f51c5-aa41-414e-a966-32e02e9e79a2
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
03-08-2023
End Marketing Date: [10]
05-09-2029
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 83018-0002?

The NDC code 83018-0002 is assigned by the FDA to the product Sinus Defense. It is commonly known by its generic name, lac vaccinum, silicea, aspergillus niger, babesia microti, borrelia burgdorferi, candida albicans, candida parapsilosis, chlamydia trachomatis, colibacillinum cum natrum muriaticum, cytomegalovirus nosode, ehrlichia nosode, herpes simplex i and ii nosode, human papilloma nosode, klebsiella pneumoniae, mucor racemosus, mycobacterium paratuberculosis, pneumoccoccinum, staphylococcus aureus, streptococcus viridans, epstein-barr virus nosode, herpes zoster nosode. This pharmaceutical product is labeled by Micro Balance Health Products Llc 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: 83018-0002-1. 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 and Children over 12: For sinus symptoms apply 3-9 sprays under tongue 2-3 times daily, or as needed. Use 9 sprays under tongue, 3 times daily when symptoms increase or additional immune support is needed. Hold spray under tongue for 15 seconds before swallowing. Consult a physician for use in children under 12 years of age. Do not take within 15 minutes of consuming food or brushing teeth.

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.
  • ASPERGILLUS NIGER VAR. NIGER 16 [hp_X]/mL
  • BABESIA MICROTI 16 [hp_X]/mL - A species of protozoa infecting humans via the intermediate tick vector IXODES scapularis. The other hosts are the mouse PEROMYSCUS leucopus and meadow vole MICROTUS pennsylvanicus, which are fed on by the tick. Other primates can be experimentally infected with Babesia microti.
  • BORRELIA BURGDORFERI 16 [hp_X]/mL - A specific species of bacteria, part of the BORRELIA BURGDORFERI GROUP, whose common name is Lyme disease spirochete.
  • CANDIDA ALBICANS 16 [hp_X]/mL - A unicellular budding fungus which is the principal pathogenic species causing CANDIDIASIS (moniliasis).
  • CANDIDA PARAPSILOSIS 16 [hp_X]/mL - A species of MITOSPORIC FUNGI and opportunistic pathogen associated with its ability to form BIOFILMS in catheters and parenteral nutrition IV lines. C. parapsilosis complex includes closely related species C. orthopsilosis; and C. metapsilosis.
  • CHLAMYDIA TRACHOMATIS 16 [hp_X]/mL - Type species of CHLAMYDIA causing a variety of ocular and urogenital diseases.
  • COW MILK 6 [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.
  • EHRLICHIA CANIS 16 [hp_X]/mL - Species of gram-negative bacteria in the family ANAPLASMATACEAE, causing EHRLICHIOSIS in DOGS. The most common vector is the brown dog tick. It can also cause disease in humans.
  • 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.
  • HUMAN HERPESVIRUS 1 16 [hp_X]/mL - The type species of SIMPLEXVIRUS causing most forms of non-genital herpes simplex in humans. Primary infection occurs mainly in infants and young children and then the virus becomes latent in the dorsal root ganglion. It then is periodically reactivated throughout life causing mostly benign conditions.
  • HUMAN HERPESVIRUS 2 16 [hp_X]/mL
  • HUMAN HERPESVIRUS 3 15 [hp_C]/mL - The type species of VARICELLOVIRUS causing CHICKENPOX (varicella) and HERPES ZOSTER (shingles) in humans.
  • HUMAN HERPESVIRUS 4 15 [hp_C]/mL
  • HUMAN HERPESVIRUS 5 16 [hp_X]/mL
  • HUMAN PAPILLOMAVIRUS 16 [hp_X]/mL
  • KLEBSIELLA PNEUMONIAE 16 [hp_X]/mL - Gram-negative, non-motile, capsulated, gas-producing rods found widely in nature and associated with urinary and respiratory infections in humans.
  • MUCOR RACEMOSUS 16 [hp_X]/mL
  • MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS 16 [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.
  • SILICON DIOXIDE 9 [hp_X]/mL - Transparent, tasteless crystals found in nature as agate, amethyst, chalcedony, cristobalite, flint, sand, QUARTZ, and tridymite. The compound is insoluble in water or acids except hydrofluoric acid.
  • 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?

* 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 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".