| PRODUCT NDC | 43857-0001 | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| PRODUCT TYPE NAME | HUMAN OTC DRUG | The translation of the dosage form Code submitted by the firm. |
| PROPRIETARY NAME | Ligatone | 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 | Arnica Montana, Bryonia, Calcarea Phosphorica, Causticum, Kali Carbonicum, Manganese Gluconate, Mezereum, Rhus Tox, Ruta Graveolens, Silicea | This is the date that the labeler indicates was the start of its marketing of the drug product. |
| DOSAGE FORM NAME | LIQUID | 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. |
| ROUTE NAME | ORAL | The translation of the route code submitted by the firm, indicating route of administration. |
| START MARKETING DATE | 4/13/2012 | This is the date that the labeler indicates was the start of its marketing of the drug product. |
| MARKETING CATEGORY NAME | UNAPPROVED HOMEOPATHIC | 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. |
| LABELER NAME | BioActive Nutritional, Inc. | |
| SUBSTANCE NAME | ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; DAPHNE MEZEREUM BARK; MANGANESE GLUCONATE; POTASSIUM CARBONATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE | An 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 STRENGTH | 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 | |
| ACTIVE INGRED UNIT | [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL | |
| PHARM CLASSES | Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC] | |