59469-058 NDC - HELMIN (ONION, ARTEMISIA ABROTANUM FLOWERING TOP, ARTEMISIA CINA PRE-FLOWERING TOP, CUPRIC OXIDE, OKOUBAKA AUBREVILLEI BARK, SCHOENOCAULON OFFICINALE SEED, AND SPIGELIA ANTHELMIA)

Drug Information

Product NDC: 59469-058

Proprietary Name: HELMIN

Non Proprietary Name: Onion, Artemisia abrotanum Flowering Top, Artemisia cina Pre-Flowering Top, Cupric Oxide, Okoubaka aubrevillei Bark, Schoenocaulon officinale Seed, and Spigelia Anthelmia

Active Ingredient(s):
  • 8 [hp_X]/50mL ARTEMISIA ABROTANUM FLOWERING TOP;
  • 12 [hp_X]/50mL ARTEMISIA CINA PRE-FLOWERING TOP;
  • 12 [hp_X]/50mL CUPRIC OXIDE;
  • 4 [hp_X]/50mL OKOUBAKA AUBREVILLEI BARK;
  • 6 [hp_X]/50mL ONION;
  • 6 [hp_X]/50mL SCHOENOCAULON OFFICINALE SEED;
  • 4 [hp_X]/50mL SPIGELIA ANTHELMIA WHOLE


Administration Route(s): ORAL

Dosage Form(s): SOLUTION/ DROPS

Pharmacy Class(es):
  • Allergens [CS];
  • Cell-mediated Immunity [PE];
  • Dietary Proteins [CS];
  • Increased Histamine Release [PE];
  • Non-Standardized Food Allergenic Extract [EPC];
  • Vegetable Proteins [CS]

Labeler Information

Labeler Name: PEKANA Naturheilmittel GmbH
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:4/12/2008

Package Information

No. Package Code Package Description Billing Unit
159469-058-201 BOTTLE, GLASS in 1 BOX (59469-058-20) / 50 mL in 1 BOTTLE, GLASS

NDC Record

Field Name Field Value Definition
PRODUCT NDC59469-058The 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 NAMEHELMINThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEOnion, Artemisia abrotanum Flowering Top, Artemisia cina Pre-Flowering Top, Cupric Oxide, Okoubaka aubrevillei Bark, Schoenocaulon officinale Seed, and Spigelia AnthelmiaThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTION/ DROPSThe 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 DATE4/12/2008This 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 NAMEPEKANA Naturheilmittel GmbHName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA CINA PRE-FLOWERING TOP; CUPRIC OXIDE; OKOUBAKA AUBREVILLEI BARK; ONION; SCHOENOCAULON OFFICINALE SEED; SPIGELIA ANTHELMIA WHOLEAn 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 STRENGTH8; 12; 12; 4; 6; 6; 4 
ACTIVE INGRED UNIT[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS] 

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