| Drug NDC: | 58048-0005 |
| 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. | |
| Proprietary Name: | Lyme And Co-infection Nosode |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. | |
| Non Proprietary Name: | Angelica Archangelica, Kali Muriaticum, Yucca Filamentosa, Cartilago Suis, Phytolacca Decandra, Hydrastis Canadensis, Rhus Tox, Causticum, Magnesia Phosphorica, Manganum Metallicum, Oxalicum Acidum, Arnica Montana, Babesia Microti, Borrelia Burgdorferi Nosode, Latrodectus Mactans, Citricum Acidum, Cytomegalovirus Nosode, Rickettsia Nosode (rickettsia Prowazekii), Chlamydia Trachomatis, Ledum Palustre |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Bhp Holdings, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. | |
| Substance Name: | ANGELICA ARCHANGELICA ROOT - 2 [hp_X]/mL ANHYDROUS CITRIC ACID - 6 [hp_C]/mL ARNICA MONTANA - 8 [hp_X]/mL BABESIA MICROTI - 12 [hp_X]/mL BORRELIA BURGDORFERI - 12 [hp_X]/mL CAUSTICUM - 6 [hp_X]/mL CHLAMYDIA TRACHOMATIS - 12 [hp_C]/mL GOLDENSEAL - 5 [hp_X]/mL HUMAN HERPESVIRUS 5 - 6 [hp_C]/mL LATRODECTUS MACTANS - 12 [hp_X]/mL Load more... LEDUM PALUSTRE TWIG - 30 [hp_C]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 8 [hp_X]/mL MANGANESE - 8 [hp_X]/mL OXALIC ACID - 8 [hp_X]/mL PHYTOLACCA AMERICANA ROOT - 4 [hp_X]/mL POTASSIUM CHLORIDE - 3 [hp_X]/mL RICKETTSIA PROWAZEKII - 8 [hp_C]/mL SUS SCROFA CARTILAGE - 4 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF - 6 [hp_X]/mL YUCCA FILAMENTOSA - 3 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | ORAL |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. | |
| Marketing Start Date: | 17 Mar, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 24 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. | |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Bhp Holdings, Inc. |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. | |
| Original Packager: | Yes |
| Whether or not the drug has been repackaged for distribution. | |
| NUI: | N0000175833 N0000175835 N0000175980 N0000008556 N0000175089 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | DTN01M69SN XF417D3PSL O80TY208ZW 1948X6KEG3 0J8NV9V5Q8 DD5FO1WKFU T6NI39QU44 ZW3Z11D0JV 7COI029E6K XJJ7QA858R Load more... 877L01IZ0P HF539G9L3Q 42Z2K6ZL8P 9E7R5L6H31 11E6VI8VEG 660YQ98I10 TVS414L9M5 73ECW5WG2F 6IO182RP7A T6VR38UJ9I |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. | |
| Pharmacologic Class MOA: | Acidifying Activity [MoA] Calcium Chelating Activity [MoA] |
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. | |
| Pharmacologic Class EPC: | Calculi Dissolution Agent [EPC] Anti-coagulant [EPC] |
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. | |
| Pharmacologic Class PE: | Decreased Coagulation Factor Activity [PE] |
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. | |
| Pharmacologic Class: | Acidifying Activity [MoA] Anti-coagulant [EPC] Calcium Chelating Activity [MoA] Calculi Dissolution Agent [EPC] Decreased Coagulation Factor Activity [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Osmotic Activity [MoA] Osmotic Laxative [EPC] Potassium Compounds [CS] Potassium Salt [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 58048-0005-1 | 60 mL in 1 BOTTLE, DROPPER (58048-0005-1) | 17 Mar, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. | ||||
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