59469-102 NDC - APO-STOM (ANTIMONY TRISULFIDE, ATROPA BELLA-DONNA FLOWERING TOP, COLCHICUM AUTUMNALE BULB, CITRULLUS COLOCYNTHIS FRUIT PULP, SODIUM PHOSPHATE, STRYCHNOS NUX-VOMICA SEED, ROBINIA PSEUDOACACIA BARK, AND ACHILLEA MILLEFOLIUM FLOWERING TOP)

Drug Information

  • Product NDC: 59469-102
  • Proprietary Name: apo-STOM
  • Non Proprietary Name: Antimony trisulfide, Atropa bella-donna Flowering Top, Colchicum autumnale Bulb, Citrullus colocynthis Fruit Pulp, Sodium phosphate, Strychnos nux-vomica Seed, Robinia pseudoacacia Bark, and Achillea millefolium Flowering Top
  • Active Ingredient(s): 2606 mg/50mL ACHILLEA MILLEFOLIUM FLOWERING TOP; 8 [hp_X]/50mL ANTIMONY TRISULFIDE; 4 [hp_X]/50mL ATROPA BELLA-DONNA FLOWERING TOP; 4 [hp_X]/50mL CITRULLUS COLOCYNTHIS FRUIT PULP; 6 [hp_X]/50mL COLCHICUM AUTUMNALE BULB; 6 [hp_X]/50mL ROBINIA PSEUDOACACIA BARK; 4 [hp_X]/50mL SODIUM PHOSPHATE; 4 [hp_X]/50mL STRYCHNOS NUX-VOMICA SEED
  • Administration Route(s): ORAL
  • Dosage Form(s): SOLUTION/ DROPS
  • Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Seed Storage Proteins [CS]

Labeler Information

Field Name Field Value
Labeler Name: PEKANA Naturheilmittel GmbH
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:12/11/2008

Package Information

No. Package Code Package Description Billing Unit
159469-102-101 BOTTLE, GLASS in 1 BOX (59469-102-10) / 50 mL in 1 BOTTLE, GLASS

NDC Record

Field Name Field Value Definition
PRODUCT NDC59469-102The 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 NAMEapo-STOMThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAntimony trisulfide, Atropa bella-donna Flowering Top, Colchicum autumnale Bulb, Citrullus colocynthis Fruit Pulp, Sodium phosphate, Strychnos nux-vomica Seed, Robinia pseudoacacia Bark, and Achillea millefolium Flowering TopThe 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 DATE12/11/2008This 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 NAMEACHILLEA MILLEFOLIUM FLOWERING TOP; ANTIMONY TRISULFIDE; ATROPA BELLA-DONNA FLOWERING TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; ROBINIA PSEUDOACACIA BARK; SODIUM PHOSPHATE; STRYCHNOS NUX-VOMICA SEEDAn 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 STRENGTH2606; 8; 4; 4; 6; 6; 4; 4 
ACTIVE INGRED UNITmg/50mL; [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], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS] 

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This page was last updated on: 7/4/2025

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