| PRODUCT NDC | 63479-0206 | 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 | B06 | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| PROPRIETARY NAME SUFFIX | Stress Resistance | A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| NON PROPRIETARY NAME | AVENA SATIVA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COFFEA CRUDA, ENGLISH OAK, ESCHSCHOLTZIA CALIFORNICA, EUROPEAN HORNBEAM, FICUS CARICA, HUMULUS LUPULUS, IGNATIA AMARA, IMPATIENS GLANDULIFERA, KALI PHOSPHORICUM, KALI SILICATUM, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PYRENEES STAR OF BETHLEHEM, ROCKROSE, SUS SCROFA PARASYMPATHETIC NERVE, PINEAL GLAND, SYMPATHETIC NERVE, VALERIANA OFFICINALIS, VERBENA OFFICINALIS, ZINCUM VALERIANICUM | 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 | SOLUTION/ DROPS | The translation of the dosage form Code submitted by the firm. |
| ROUTE NAME | SUBLINGUAL | The translation of the route code submitted by the firm, indicating route of administration. |
| START MARKETING DATE | 8/15/1988 | 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 | Apex Energetics Inc. | Name of Company corresponding to the labeler code segment of the Product NDC. |
| SUBSTANCE NAME | ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; CARPINUS BETULUS FLOWER; CLEMATIS VITALBA FLOWER; DIBASIC POTASSIUM PHOSPHATE; ESCHSCHOLZIA CALIFORNICA; FICUS CARICA FLOWER BUD; HELIANTHEMUM NUMMULARIUM FLOWER; HOPS; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA CHAMOMILLA; MELISSA OFFICINALIS; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; POTASSIUM SILICATE; PRUNUS CERASIFERA FLOWER; QUERCUS ROBUR FLOWER; STRYCHNOS IGNATII SEED; SUS SCROFA PARASYMPATHETIC NERVE; SUS SCROFA PINEAL GLAND; SUS SCROFA SYMPATHETIC NERVE; VALERIAN; VERBENA OFFICINALIS FLOWERING TOP; ZINC VALERATE DIHYDRATE | 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; 1; 15; 15; 15; 6; 9; 15; 4; 15; 30; 6; 15; 4; 30; 15; 15; 15; 30; 7; 7; 7; 6; 15; 15 | |
| 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; [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_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL | |
| PHARM CLASSES | Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Seed Storage Proteins [CS] | |