57955-2803 NDC - ADVANCED ARNICA PLUS (ARNICA MONTANA, ARNICA MONTANA, RADIX, BELLIS PERENNIS, BRYONIA, HYPERICUM PERFORATUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, PHYTOLACCA DECANDRA, RHUS TOX, RUTA GRAVEOLENS)

Drug Information

Product NDC: 57955-2803

Proprietary Name: Advanced Arnica Plus

Non Proprietary Name: Arnica montana, Arnica montana, radix, Bellis perennis, Bryonia, Hypericum perforatum, Lithium carbonicum, Magnesia phosphorica, Phytolacca decandra, Rhus tox, Ruta graveolens

Active Ingredient(s):
  • 10 [hp_X]/59mL ARNICA MONTANA ROOT;
  • 10 [hp_X]/59mL ARNICA MONTANA WHOLE;
  • 10 [hp_X]/59mL BELLIS PERENNIS WHOLE;
  • 10 [hp_X]/59mL BRYONIA ALBA ROOT;
  • 10 [hp_X]/59mL HYPERICUM PERFORATUM WHOLE;
  • 10 [hp_X]/59mL LITHIUM CARBONATE;
  • 10 [hp_X]/59mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE;
  • 10 [hp_X]/59mL PHYTOLACCA AMERICANA ROOT;
  • 10 [hp_X]/59mL RUTA GRAVEOLENS FLOWERING TOP;
  • 10 [hp_X]/59mL TOXICODENDRON PUBESCENS LEAF


Administration Route(s): ORAL

Dosage Form(s): LIQUID

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];
  • Mood Stabilizer [EPC];
  • Osmotic Activity [MoA];
  • Osmotic Laxative [EPC];
  • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Labeler Information

Labeler Name: King Bio Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:9/26/2022

Package Information

No. Package Code Package Description Billing Unit
157955-2803-21 BOTTLE, SPRAY in 1 CARTON (57955-2803-2) / 59 mL in 1 BOTTLE, SPRAY

NDC Record

Field Name Field Value Definition
PRODUCT NDC57955-2803The 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 NAMEAdvanced Arnica PlusThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEArnica montana, Arnica montana, radix, Bellis perennis, Bryonia, Hypericum perforatum, Lithium carbonicum, Magnesia phosphorica, Phytolacca decandra, Rhus tox, Ruta graveolensThe 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 DATE9/26/2022This 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 NAMEKing Bio Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEARNICA MONTANA ROOT; ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM WHOLE; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAFAn 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 STRENGTH10; 10; 10; 10; 10; 10; 10; 10; 10; 10 
ACTIVE INGRED UNIT[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 
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], Mood Stabilizer [EPC], 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