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58264-0304 NDC - A-12 (JUNIPERUS ASHEI POLLEN, JUNIPERUS VIRGINIANA POLLEN, TAMARIX GALLICA POLLEN, CUPRESSUS ARIZONICA POLLEN, TAXODIUM DISTICHUM POLLEN, JUNIPERUS MONOSPERMA POLLEN, JUNIPERUS PINCHOTII POLLEN, JUNIPERUS SCOPULORUM POLLEN, PINUS TAEDA POLLEN, PINUS STROBUS POLLEN, AND PINUS ECHINATA POLLEN)

Drug Information

Product NDC: 58264-0304

Proprietary Name: A-12

Non Proprietary Name: JUNIPERUS ASHEI POLLEN, JUNIPERUS VIRGINIANA POLLEN, TAMARIX GALLICA POLLEN, CUPRESSUS ARIZONICA POLLEN, TAXODIUM DISTICHUM POLLEN, JUNIPERUS MONOSPERMA POLLEN, JUNIPERUS PINCHOTII POLLEN, JUNIPERUS SCOPULORUM POLLEN, PINUS TAEDA POLLEN, PINUS STROBUS POLLEN, and PINUS ECHINATA POLLEN

Active Ingredient(s):
  • 30 [hp_X]/mL CUPRESSUS ARIZONICA POLLEN;
  • 30 [hp_X]/mL JUNIPERUS ASHEI POLLEN;
  • 30 [hp_X]/mL JUNIPERUS MONOSPERMA POLLEN;
  • 30 [hp_X]/mL JUNIPERUS PINCHOTII POLLEN;
  • 30 [hp_X]/mL JUNIPERUS SCOPULORUM POLLEN;
  • 30 [hp_X]/mL JUNIPERUS VIRGINIANA POLLEN;
  • 30 [hp_X]/mL PINUS ECHINATA POLLEN;
  • 30 [hp_X]/mL PINUS STROBUS POLLEN;
  • 30 [hp_X]/mL PINUS TAEDA POLLEN;
  • 30 [hp_X]/mL TAMARIX GALLICA POLLEN;
  • 30 [hp_X]/mL TAXODIUM DISTICHUM POLLEN


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];
  • 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];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [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 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];
  • Increased IgG Production [PE];
  • Increased IgG Production [PE];
  • Increased IgG Production [PE];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Pollen [CS];
  • Pollen [CS];
  • Pollen [CS];
  • Pollen [CS];
  • Pollen [CS];
  • Pollen [CS];
  • Pollen [CS];
  • Pollen [CS];
  • Pollen [CS];
  • Pollen [CS];
  • Pollen [CS];
  • Pollen [CS]

Labeler Information

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
158264-0304-129.57 mL in 1 BOTTLE, GLASS (58264-0304-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC58264-0304The 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-12The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEJUNIPERUS ASHEI POLLEN, JUNIPERUS VIRGINIANA POLLEN, TAMARIX GALLICA POLLEN, CUPRESSUS ARIZONICA POLLEN, TAXODIUM DISTICHUM POLLEN, JUNIPERUS MONOSPERMA POLLEN, JUNIPERUS PINCHOTII POLLEN, JUNIPERUS SCOPULORUM POLLEN, PINUS TAEDA POLLEN, PINUS STROBUS POLLEN, and PINUS ECHINATA POLLENThe 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 NAMECUPRESSUS ARIZONICA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; PINUS ECHINATA POLLEN; PINUS STROBUS POLLEN; PINUS TAEDA POLLEN; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLENAn 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; 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; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Allergens [CS], 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], Cell-mediated Immunity [PE], Cell-mediated Immunity [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 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS] 

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This page was last updated on: 2/1/2023
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