NDC 59469-201 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

NDC Product Code 59469-201

NDC CODE: 59469-201

Proprietary Name: Bolym-ex Drops What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

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 What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 59469 - Pekana Naturheilmittel Gmbh

NDC 59469-201-10

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 50 mL in 1 BOTTLE, DROPPER

NDC Product Information

Bolym-ex Drops with NDC 59469-201 is a a human over the counter drug product labeled by Pekana Naturheilmittel Gmbh. The generic name of Bolym-ex Drops is 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. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Pekana Naturheilmittel Gmbh

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates 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.

Bolym-ex Drops Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZOIC ACID 5 [hp_X]/50mL
  • FORMIC ACID 5 [hp_X]/50mL
  • ARISTOLOCHIA CLEMATITIS ROOT 24 [hp_X]/50mL
  • FERULA ASSA-FOETIDA RESIN 5 [hp_X]/50mL
  • AVENA SATIVA FLOWERING TOP 4 [hp_X]/50mL
  • BERBERIS VULGARIS ROOT BARK 5 [hp_X]/50mL
  • CALCIUM PHOSPHATE, UNSPECIFIED FORM 8 [hp_X]/50mL
  • CAPSELLA BURSA-PASTORIS 5 [hp_X]/50mL
  • GALIUM APARINE 5 [hp_X]/50mL
  • DAPHNE MEZEREUM BARK 8 [hp_X]/50mL
  • MACROPIPER METHYSTICUM ROOT 10 [hp_X]/50mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pekana Naturheilmittel Gmbh
Labeler Code: 59469
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product 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.

Start Marketing Date: 06-01-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Bolym-ex Drops Product Label Images

Bolym-ex Drops Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Ingredients

Acidum benzoicum5XAcidum formicicum5XAristolochia clematitis24XAsa foetida5XAvena sativa4XBerberis vulgaris5XCalcium phosphoricum8XCapsella bursa-pastoris5XGalium aparine5XDaphne mezereum (Mezereum)8XPiper methysticum10XSelected ingredients prepared by spagyric processes.

Inactive Ingredient

Contains 18% alcohol by volume.

Otc - Purpose

Supports relief of minor symptoms related to tick-borne disease. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

Dosage

Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

Otc - Ask Doctor

If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Storage And Handling

Protect from light and heat.

Tamper Evident

Do not use this product if tamper evident strip is broken or removed from base of cap.

Other

Distributed by:BioResource Inc.Cotati, CA 94931Manufactured by:PEKANA® GmbHD-88353 Kisslegg

* Please review the disclaimer below.