| PRODUCT NDC | 83027-0050 | 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 | Virex | 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 | Asclepias Tuberosa, Echinacea Purpurea, Trifolium Pratense, Natrum Muriaticum, Phytolacca Decandra, Euphrasia Officinalis, Lac Vaccinum (NSPC), Thuja Occidentalis, Calcarea Arsenicica, Camphora, Influenzinum, Cytomegalovirus Nosode, Morbillinum, Variolinum, Coxsackie A2 Nosode, Coxsackie A3 Nosode, Coxsackie A4 Nosode, Coxsackie A7 Nosode, Coxsackie B1 Nosode, Coxsackie B3 Nosode, Coxsackie B5 Nosode, Coxsackie A5 Nosode, Adenoviren Nosode, Epstein Barr Virus Nosode, Coxsackie B4 Nosode | 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 | SPRAY | 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 | 4/13/2023 | 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 | Nutritional Specialties, Inc. | Name of Company corresponding to the labeler code segment of the Product NDC. |
| SUBSTANCE NAME | ASCLEPIAS TUBEROSA ROOT; CALCIUM ARSENATE; CAMPHOR (NATURAL); COW MILK; ECHINACEA PURPUREA WHOLE; EUPHRASIA STRICTA; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; HUMAN COXSACKIEVIRUS A; HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B3; HUMAN COXSACKIEVIRUS B5; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 5; INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED); MEASLES VIRUS; PHYTOLACCA AMERICANA ROOT; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; TRIFOLIUM PRATENSE FLOWER; VARIOLA VIRUS | 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 | 3; 12; 12; 6; 3; 6; 15; 9; 9; 9; 18; 9; 9; 9; 15; 15; 12; 12; 12; 12; 16; 4; 4; 6; 3; 16 | |
| ACTIVE INGRED UNIT | [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_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/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 | |
| PHARM CLASSES | Actively Acquired Immunity [PE], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Live Human Adenovirus Type 4 Vaccine [EPC], Milk Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Live, Unattenuated [Chemical/Ingredient] | |