| PRODUCT NDC | 55714-2549 | The 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 NAME | HUMAN OTC DRUG | 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. |
| PROPRIETARY NAME | Bowel - Digestive Care | 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 | Bismuthum metallicum, Antimon.crud., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia. | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| DOSAGE FORM NAME | PELLET | The translation of the dosage form Code submitted by the firm. |
| ROUTE NAME | ORAL | The translation of the route code submitted by the firm, indicating route of administration. |
| START MARKETING DATE | 7/1/2019 | 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 | Newton Laboratories, Inc. | Name of Company corresponding to the labeler code segment of the Product NDC. |
| SUBSTANCE NAME | ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; GINGER; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RADISH; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS | 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 | 15; 15; 15; 15; 15; 15; 6; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 | |
| ACTIVE INGRED UNIT | [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_M]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g | |
| PHARM CLASSES | Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Nut Proteins [EXT], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS] | |