59469-201 NDC - BOLYM-EX DROPS (BENZOIC ACID, FORMIC ACID, ARISTOLOCHIA CLEMATITIS ROOT, FERULA ASSA-FOETIDA RESIN, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, CALCIUM PHOSPHATE, UNSPECIFIED FORM, CAPSELLA BURSA-PASTORIS, GALIUM APARINE, DAPHNE MEZEREUM BARK, AND PIPER METHYSTICUM ROOT)

Drug Information

  • Product NDC: 59469-201
  • Proprietary Name: BOLYM-EX Drops
  • Non Proprietary Name: Benzoic Acid, Formic Acid, Aristolochia Clematitis Root, FERULA ASSA-FOETIDA RESIN, Avena Sativa Flowering Top, Berberis Vulgaris Root Bark, CALCIUM PHOSPHATE, UNSPECIFIED FORM, Capsella bursa-pastoris, Galium aparine, Daphne Mezereum Bark, and Piper Methysticum Root
  • Active Ingredient(s): 24 [hp_X]/50mL ARISTOLOCHIA CLEMATITIS ROOT; 4 [hp_X]/50mL AVENA SATIVA FLOWERING TOP; 5 [hp_X]/50mL BENZOIC ACID; 5 [hp_X]/50mL BERBERIS VULGARIS ROOT BARK; 8 [hp_X]/50mL CALCIUM PHOSPHATE, UNSPECIFIED FORM; 5 [hp_X]/50mL CAPSELLA BURSA-PASTORIS WHOLE; 8 [hp_X]/50mL DAPHNE MEZEREUM BARK; 5 [hp_X]/50mL FERULA ASSA-FOETIDA RESIN; 5 [hp_X]/50mL FORMIC ACID; 5 [hp_X]/50mL GALIUM APARINE WHOLE; 10 [hp_X]/50mL MACROPIPER METHYSTICUM ROOT
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Ammonium Ion Binding Activity [MoA]; Blood Coagulation Factor [EPC]; Calcium [CS]; Cations; Divalent [CS]; Increased Coagulation Factor Activity [PE]; Nitrogen Binding Agent [EPC]

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:6/1/2015

Package Information

No. Package Code Package Description Billing Unit
159469-201-101 BOTTLE, DROPPER in 1 CARTON (59469-201-10) / 50 mL in 1 BOTTLE, DROPPER

NDC Record

Field Name Field Value Definition
PRODUCT NDC59469-201The 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 NAMEBOLYM-EX DropsThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBenzoic Acid, Formic Acid, Aristolochia Clematitis Root, FERULA ASSA-FOETIDA RESIN, Avena Sativa Flowering Top, Berberis Vulgaris Root Bark, CALCIUM PHOSPHATE, UNSPECIFIED FORM, Capsella bursa-pastoris, Galium aparine, Daphne Mezereum Bark, and Piper Methysticum RootThe 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 DATE6/1/2015This 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 NAMEARISTOLOCHIA CLEMATITIS ROOT; AVENA SATIVA FLOWERING TOP; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; CALCIUM PHOSPHATE, UNSPECIFIED FORM; CAPSELLA BURSA-PASTORIS WHOLE; DAPHNE MEZEREUM BARK; FERULA ASSA-FOETIDA RESIN; FORMIC ACID; GALIUM APARINE WHOLE; MACROPIPER METHYSTICUM ROOTAn 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 STRENGTH24; 4; 5; 5; 8; 5; 8; 5; 5; 5; 10 
ACTIVE INGRED UNIT[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 
PHARM CLASSESAmmonium Ion Binding Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Nitrogen Binding Agent [EPC] 

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This page was last updated on: 11/21/2025

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