| Drug NDC: | 72190-0001 |
| 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: | Metalock |
| 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: | Passiflora Incarnata, Chamomilla, Valeriana Officinalis, Fucus Officinalis, Agnus Castus, Kali Phosphoricum, Natrum Muriaticum, Nux Vomica, Phytolacca Decandra, Chelidonium Majus, Lycopodium Clavatum, Pituitarum Posterium (bovine), Adrenocorticotrophin, Thyroidinum (bovine), Thyroidinum (ovine), Calcarea Carbonica, Carbo Vegetabilis, Magnesia Phosphorica, Natrum Phosphoricum, Ubidecarenonum, Graphites, Hypophysis Suis, Hypothalamus (bovine), Placenta Totalis Suis, Argentum Nitricum, Berberis Vulgaris, |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Real Health Medical, Llc |
| 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: | ACTIVATED CHARCOAL - 12 [hp_X]/mL AESCULUS HIPPOCASTANUM FLOWER - 9 [hp_C]/mL AGRIMONIA EUPATORIA FLOWER - 6 [hp_C]/mL ANEMONE PULSATILLA - 20 [hp_X]/mL BERBERIS VULGARIS ROOT BARK - 20 [hp_X]/mL BOS TAURUS HYPOTHALAMUS - 12 [hp_X]/mL BOS TAURUS PITUITARY GLAND, POSTERIOR - 10 [hp_X]/mL BRYONIA ALBA ROOT - 20 [hp_X]/mL CASTANEA SATIVA LEAF - 6 [hp_C]/mL CENTAURIUM ERYTHRAEA FLOWER - 9 [hp_C]/mL Load more... CERATOSTIGMA WILLMOTTIANUM FLOWER - 6 [hp_C]/mL CHASTE TREE FRUIT - 6 [hp_X]/mL CHELIDONIUM MAJUS - 6 [hp_X]/mL CORTICOTROPIN - 10 [hp_X]/mL DATURA STRAMONIUM - 20 [hp_X]/mL DIBASIC POTASSIUM PHOSPHATE - 6 [hp_X]/mL DIGITALIS - 20 [hp_X]/mL FUCUS VESICULOSUS - 4 [hp_X]/mL GRAPHITE - 12 [hp_X]/mL IRIS VERSICOLOR ROOT - 20 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 6 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 12 [hp_X]/mL MATRICARIA CHAMOMILLA - 3 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE - 12 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP - 3 [hp_X]/mL PHYTOLACCA AMERICANA ROOT - 6 [hp_X]/mL POTASSIUM CARBONATE - 20 [hp_X]/mL SCUTELLARIA LATERIFLORA - 20 [hp_X]/mL SEMECARPUS ANACARDIUM JUICE - 200 [hp_X]/mL SEPIA OFFICINALIS JUICE - 20 [hp_X]/mL SILVER NITRATE - 20 [hp_X]/mL SODIUM CARBONATE - 20 [hp_X]/mL SODIUM CHLORIDE - 6 [hp_X]/mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE - 12 [hp_X]/mL SODIUM SULFATE - 20 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED - 6 [hp_X]/mL SUS SCROFA PITUITARY GLAND - 12 [hp_X]/mL SUS SCROFA PLACENTA - 12 [hp_X]/mL THYROID, BOVINE - 10 [hp_X]/mL THYROID, OVINE - 1 [hp_Q]/mL TOXICODENDRON PUBESCENS LEAF - 20 [hp_X]/mL UBIDECARENONE - 12 [hp_X]/mL VALERIAN - 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: | 04 Apr, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 18 Apr, 2024 |
| 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: | 22 Dec, 2025 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Real Health Medical, LLC |
| 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: | M0000499 N0000175941 N0000185375 N0000175629 N0000184306 N0000185001 M0000728 M0016962 M0516536 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2P3VWU3H10 KK0Z92II8M 5811MI029U I76KB35JEV 1TH8Q20J0U S6G2NLH4Y7 7JM57I419K T7J046YI2B IV3S2HH53G B204P54Z1F Load more... TP69J995TW 433OSF3U8A 7E889U5RNN K0U68Q2TXA G6W4F0V8Z3 CI71S98N1Z F1T8QT9U8B 535G2ABX9M 4QQN74LH4O X43D4L3DQC C88X29Y479 HF539G9L3Q G0R4UBI2ZZ 2E32821G6I CLF5YFS11O 11E6VI8VEG BQN1B9B9HA 7BP4DH5PDC Y0F0BU8RDU QDL83WN8C2 95IT3W8JZE 45P3261C7T 451W47IQ8X 70WT22SF4B 0YPR65R21J 269XH13919 L0PFEMQ1DT C8CV8867O8 MN18OTN73W T55183XHD6 6IO182RP7A EJ27X76M46 JWF5YAW3QW |
| 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 EPC: | Adrenocorticotropic Hormone [EPC] Non-Standardized Plant Allergenic Extract [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: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [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 CS: | Adrenocorticotropic Hormone [CS] Allergens [CS] Plant Proteins [CS] Seed Storage Proteins [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Adrenocorticotropic Hormone [CS] Adrenocorticotropic Hormone [EPC] Allergens [CS] Calculi Dissolution Agent [EPC] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Increased IgG Production [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] Non-Standardized Plant Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Plant Proteins [CS] Seed Storage Proteins [CS] 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 |
|---|---|---|---|---|
| 72190-0001-1 | 59 mL in 1 BOTTLE, DROPPER (72190-0001-1) | 04 Apr, 2019 | 18 Apr, 2024 | 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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