83018-0002 NDC - 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)

Drug Information

  • Product NDC: 83018-0002
  • Proprietary Name: Sinus Defense
  • Non Proprietary 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
  • Active Ingredient(s): 16 [hp_X]/mL ASPERGILLUS NIGER VAR. NIGER; 16 [hp_X]/mL BABESIA MICROTI; 16 [hp_X]/mL BORRELIA BURGDORFERI; 16 [hp_X]/mL CANDIDA ALBICANS; 16 [hp_X]/mL CANDIDA PARAPSILOSIS; 16 [hp_X]/mL CHLAMYDIA TRACHOMATIS; 6 [hp_X]/mL COW MILK; 16 [hp_X]/mL EHRLICHIA CANIS; 16 [hp_X]/mL ESCHERICHIA COLI; 16 [hp_X]/mL HUMAN HERPESVIRUS 1; 16 [hp_X]/mL HUMAN HERPESVIRUS 2; 15 [hp_C]/mL HUMAN HERPESVIRUS 3; 15 [hp_C]/mL HUMAN HERPESVIRUS 4; 16 [hp_X]/mL HUMAN HERPESVIRUS 5; 16 [hp_X]/mL HUMAN PAPILLOMAVIRUS; 16 [hp_X]/mL KLEBSIELLA PNEUMONIAE; 16 [hp_X]/mL MUCOR RACEMOSUS; 16 [hp_X]/mL MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS; 9 [hp_X]/mL SILICON DIOXIDE; 16 [hp_X]/mL STAPHYLOCOCCUS AUREUS; 16 [hp_X]/mL STREPTOCOCCUS PNEUMONIAE; 16 [hp_X]/mL STREPTOCOCCUS VIRIDANS GROUP
  • Administration Route(s): ORAL
  • Dosage Form(s): SPRAY
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Milk Proteins [CS]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Micro Balance Health Products LLC
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:3/8/2023

Package Information

No. Package Code Package Description Billing Unit
183018-0002-160 mL in 1 BOTTLE, SPRAY (83018-0002-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC83018-0002The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMESinus DefenseThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMELac 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 NosodeThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESPRAYThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/8/2023This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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.
LABELER NAMEMicro Balance Health Products LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEASPERGILLUS 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 GROUPAn 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.
ACTIVE NUMERATOR STRENGTH16; 16; 16; 16; 16; 16; 6; 16; 16; 16; 16; 15; 15; 16; 16; 16; 16; 16; 9; 16; 16; 16 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Milk Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC] 

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This page was last updated on: 7/4/2025

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