58264-0313 NDC - A-21 (ALTERNARIA ALTERNATA, ASPERGILLUS NIGER VAR. NIGER, COCHLIOBOLUS SPICIFER, GIBBERELLA FUJIKUROI, COCHLIOBOLUS SATIVUS, CLADOSPORIUM BRUHNEI, MUCOR PLUMBEUS, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, AUREOBASIDIUM PULLULANS VAR. PULLUTANS, AND RHIZOPUS STOLONIFER)

Drug Information

  • Product NDC: 58264-0313
  • Proprietary Name: A-21
  • Non Proprietary Name: ALTERNARIA ALTERNATA, ASPERGILLUS NIGER VAR. NIGER, COCHLIOBOLUS SPICIFER, GIBBERELLA FUJIKUROI, COCHLIOBOLUS SATIVUS, CLADOSPORIUM BRUHNEI, MUCOR PLUMBEUS, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, AUREOBASIDIUM PULLULANS VAR. PULLUTANS, and RHIZOPUS STOLONIFER
  • Active Ingredient(s): 30 [hp_X]/mL ALTERNARIA ALTERNATA; 30 [hp_X]/mL ASPERGILLUS NIGER VAR. NIGER; 30 [hp_X]/mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS; 30 [hp_X]/mL CLADOSPORIUM BRUHNEI; 30 [hp_X]/mL COCHLIOBOLUS SATIVUS; 30 [hp_X]/mL COCHLIOBOLUS SPICIFER; 30 [hp_X]/mL GIBBERELLA FUJIKUROI; 30 [hp_X]/mL MUCOR PLUMBEUS; 30 [hp_X]/mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; 30 [hp_X]/mL RHIZOPUS STOLONIFER
  • Administration Route(s): SUBLINGUAL
  • Dosage Form(s): SOLUTION
  • 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]; 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 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]

Labeler Information

Field Name Field Value
Labeler Name: DNA Labs, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:1/1/1990

Package Information

No. Package Code Package Description Billing Unit
158264-0313-129.57 mL in 1 BOTTLE, GLASS (58264-0313-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC58264-0313The 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 NAMEA-21The 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 NIGER VAR. NIGER, COCHLIOBOLUS SPICIFER, GIBBERELLA FUJIKUROI, COCHLIOBOLUS SATIVUS, CLADOSPORIUM BRUHNEI, MUCOR PLUMBEUS, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, AUREOBASIDIUM PULLULANS VAR. PULLUTANS, and RHIZOPUS STOLONIFERThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMESUBLINGUALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/1/1990This 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 NAMEDNA Labs, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CLADOSPORIUM BRUHNEI; COCHLIOBOLUS SATIVUS; COCHLIOBOLUS SPICIFER; GIBBERELLA FUJIKUROI; MUCOR PLUMBEUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; RHIZOPUS STOLONIFERAn 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 STRENGTH30; 30; 30; 30; 30; 30; 30; 30; 30; 30 
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 
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], 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 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] 

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This page was last updated on: 12/6/2025

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