81825-0002 NDC - MOLD ANTIGEN (ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCC)

Drug Information

  • Product NDC: 81825-0002
  • Proprietary Name: Mold Antigen
  • Non Proprietary Name: Alternaria Alternata, Aspergillus Fumigatus, Aspergillus Niger, Boletus Sat, Botrytis Cinerea, Cladosporium Metanigrum, Fusarium Oxysporum, Helminthosporium, Mucor Muecedo, Pullularia Pullulans, Rhizopus Nigricans, Ustilago Maydis, Arsenicum Alb, Candida Alb, Carbo An, Lachesis, Lycopodium, Merc Solub, Nitricum Ac, Phosphorus, Pulsatilla, Sepia, Silicea, Thuja Occ
  • Active Ingredient(s): 200 [hp_X]/mL ALTERNARIA ALTERNATA; 30 [hp_C]/mL ARSENIC TRIOXIDE; 200 [hp_X]/mL ASPERGILLUS FUMIGATUS; 200 [hp_X]/mL ASPERGILLUS NIGER VAR. NIGER; 200 [hp_X]/mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS; 200 [hp_X]/mL BOLETUS SATANAS FRUITING BODY; 200 [hp_X]/mL BOTRYTIS CINEREA; 30 [hp_C]/mL CANDIDA ALBICANS; 30 [hp_C]/mL CARBO ANIMALIS; 200 [hp_X]/mL COCHLIOBOLUS SATIVUS; 200 [hp_X]/mL FUSARIUM OXYSPORUM; 30 [hp_C]/mL LACHESIS MUTA VENOM; 30 [hp_C]/mL LYCOPODIUM CLAVATUM SPORE; 30 [hp_C]/mL MERCURIUS SOLUBILIS; 30 [hp_C]/mL NITRIC ACID; 30 [hp_C]/mL PHOSPHORUS; 30 [hp_C]/mL PULSATILLA VULGARIS WHOLE; 200 [hp_X]/mL RHIZOPUS STOLONIFER; 30 [hp_C]/mL SEPIA OFFICINALIS JUICE; 30 [hp_C]/mL SILICON DIOXIDE; 30 [hp_C]/mL THUJA OCCIDENTALIS LEAFY TWIG; 200 [hp_X]/mL USTILAGO MAYDIS
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; 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]; Cell-mediated Immunity [PE]; Fungal 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]; 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 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]; Increased IgG Production [PE]; Increased IgG Production [PE]; 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]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Zorex International
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:12/1/2021

Package Information

No. Package Code Package Description Billing Unit
181825-0002-130 mL in 1 BOTTLE, DROPPER (81825-0002-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC81825-0002The 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 NAMEMold AntigenThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAlternaria Alternata, Aspergillus Fumigatus, Aspergillus Niger, Boletus Sat, Botrytis Cinerea, Cladosporium Metanigrum, Fusarium Oxysporum, Helminthosporium, Mucor Muecedo, Pullularia Pullulans, Rhizopus Nigricans, Ustilago Maydis, Arsenicum Alb, Candida Alb, Carbo An, Lachesis, Lycopodium, Merc Solub, Nitricum Ac, Phosphorus, Pulsatilla, Sepia, Silicea, Thuja OccThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe 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 DATE12/1/2021This 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 NAMEZorex InternationalName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALTERNARIA ALTERNATA; ARSENIC TRIOXIDE; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOLETUS SATANAS FRUITING BODY; BOTRYTIS CINEREA; CANDIDA ALBICANS; CARBO ANIMALIS; COCHLIOBOLUS SATIVUS; FUSARIUM OXYSPORUM; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; RHIZOPUS STOLONIFER; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; USTILAGO MAYDISAn 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 STRENGTH200; 30; 200; 200; 200; 200; 200; 30; 30; 200; 200; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 200 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_C]/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_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], 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], Cell-mediated Immunity [PE], Fungal 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], 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 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], Increased IgG Production [PE], Increased IgG Production [PE], 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], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC] 

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This page was last updated on: 6/6/2025

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