59469-066 NDC - KELAN (SILICON DIOXIDE, ARNICA MONTANA ROOT, GRAPHITE, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, MAGNESIUM FLUORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, AND RUTA GRAVEOLENS FLOWERING TOP)

Drug Information

Product NDC: 59469-066

Proprietary Name: KELAN

Non Proprietary Name: Silicon Dioxide, Arnica montana Root, Graphite, Hypericum Perforatum, Ledum Palustre Twig, Magnesium fluoride, Magnesium Sulfate Heptahydrate, and Ruta graveolens Flowering Top

Active Ingredient(s):
  • 12 [hp_X]/35g ARNICA MONTANA ROOT;
  • 6 [hp_X]/35g GRAPHITE;
  • 6 [hp_X]/35g HYPERICUM PERFORATUM WHOLE;
  • 12 [hp_X]/35g MAGNESIUM FLUORIDE;
  • 12 [hp_X]/35g MAGNESIUM SULFATE HEPTAHYDRATE;
  • 12 [hp_X]/35g RHODODENDRON TOMENTOSUM LEAFY TWIG;
  • 12 [hp_X]/35g RUTA GRAVEOLENS FLOWERING TOP;
  • 6 [hp_X]/35g SILICON DIOXIDE


Administration Route(s): CUTANEOUS

Dosage Form(s): OINTMENT

Pharmacy Class(es):
  • Calculi Dissolution Agent [EPC];
  • Increased Large Intestinal Motility [PE];
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE];
  • Inhibition Small Intestine Fluid/Electrolyte Absorption [PE];
  • Magnesium Ion Exchange Activity [MoA];
  • Osmotic Activity [MoA];
  • Osmotic Laxative [EPC];
  • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

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
159469-066-301 TUBE in 1 BOX (59469-066-30) / 30 g in 1 TUBE
259469-066-351 TUBE in 1 BOX (59469-066-35) / 35 g in 1 TUBE

NDC Record

Field Name Field Value Definition
PRODUCT NDC59469-066The 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 NAMEKELANThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMESilicon Dioxide, Arnica montana Root, Graphite, Hypericum Perforatum, Ledum Palustre Twig, Magnesium fluoride, Magnesium Sulfate Heptahydrate, and Ruta graveolens 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 NAMEOINTMENTThe translation of the dosage form Code submitted by the firm.
ROUTE NAMECUTANEOUSThe 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 NAMEARNICA MONTANA ROOT; GRAPHITE; HYPERICUM PERFORATUM WHOLE; MAGNESIUM FLUORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDEAn 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 STRENGTH12; 6; 6; 12; 12; 12; 12; 6 
ACTIVE INGRED UNIT[hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g 
PHARM CLASSESCalculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 

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