83027-0133 NDC - MYCOTOX (GLANDULA SUPRARENALIS (BOVINE), SPLEEN (BOVINE), TABEBUIA IMPETIGINOSA (PAU D ARCO), THUJA OCCIDENTALIS, THYMUS (OVINE), THYROIDINUM (BOVINE), BORAX, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYMPH NODE (SUIS), ARSENICUM ALBUM, ZINCUM METALLICUM, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, MUCOR RACEMOSUS, TORULA CEREVISIAE, ALTERNARIA TENUIS NEES, CANDIDA KRUSEI, RHIZOPUS NIGRICANS, CANDIDA TROPICALIS)

Drug Information

  • Product NDC: 83027-0133
  • Proprietary Name: Mycotox
  • Non Proprietary Name: Glandula Suprarenalis (Bovine), Spleen (Bovine), Tabebuia Impetiginosa (Pau D Arco), Thuja Occidentalis, Thymus (Ovine), Thyroidinum (Bovine), Borax, Colchicum Autumnale, Lacticum Acidum, Lymph Node (Suis), Arsenicum Album, Zincum Metallicum, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Torula Cerevisiae, Alternaria Tenuis Nees, Candida Krusei, Rhizopus Nigricans, Candida Tropicalis
  • Active Ingredient(s): 60 [hp_X]/mL ALTERNARIA ALTERNATA; 12 [hp_X]/mL ARSENIC TRIOXIDE; 16 [hp_X]/mL ASPERGILLUS NIGER VAR. NIGER; 6 [hp_X]/mL BOS TAURUS ADRENAL GLAND; 6 [hp_X]/mL BOS TAURUS SPLEEN; 16 [hp_X]/mL CANDIDA ALBICANS; 16 [hp_X]/mL CANDIDA PARAPSILOSIS; 32 [hp_C]/mL CANDIDA TROPICALIS; 6 [hp_X]/mL COLCHICUM AUTUMNALE BULB; 6 [hp_X]/mL HANDROANTHUS IMPETIGINOSUS BARK; 16 [hp_C]/mL ISSATCHENKIA ORIENTALIS WHOLE; 6 [hp_X]/mL LACTIC ACID, DL-; 6 [hp_X]/mL LAMB; 16 [hp_X]/mL MUCOR RACEMOSUS; 16 [hp_C]/mL RHIZOPUS STOLONIFER; 16 [hp_X]/mL SACCHAROMYCES CEREVISIAE; 6 [hp_X]/mL SODIUM BORATE; 8 [hp_X]/mL SUS SCROFA LYMPH; 6 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG; 6 [hp_X]/mL THYROID, BOVINE; 12 [hp_X]/mL ZINC
  • Administration Route(s): ORAL
  • Dosage Form(s): SPRAY
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Dietary Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal 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 Histamine Release [PE]; 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]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Meat Proteins [EXT]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal 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: Nutritional Specialties, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:9/25/2024

Package Information

No. Package Code Package Description Billing Unit
183027-0133-160 mL in 1 BOTTLE, SPRAY (83027-0133-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC83027-0133The 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 NAMEMycotoxThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEGlandula Suprarenalis (Bovine), Spleen (Bovine), Tabebuia Impetiginosa (Pau D Arco), Thuja Occidentalis, Thymus (Ovine), Thyroidinum (Bovine), Borax, Colchicum Autumnale, Lacticum Acidum, Lymph Node (Suis), Arsenicum Album, Zincum Metallicum, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Torula Cerevisiae, Alternaria Tenuis Nees, Candida Krusei, Rhizopus Nigricans, Candida TropicalisThe 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 DATE9/25/2024This 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 NAMENutritional Specialties, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALTERNARIA ALTERNATA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CANDIDA TROPICALIS; COLCHICUM AUTUMNALE BULB; HANDROANTHUS IMPETIGINOSUS BARK; ISSATCHENKIA ORIENTALIS WHOLE; LACTIC ACID, DL-; LAMB; MUCOR RACEMOSUS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SODIUM BORATE; SUS SCROFA LYMPH; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, BOVINE; ZINCAn 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 STRENGTH60; 12; 16; 6; 6; 16; 16; 32; 6; 6; 16; 6; 6; 16; 16; 16; 6; 8; 6; 6; 12 
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_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/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], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal 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 Histamine Release [PE], 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal 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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