| Drug NDC: | 44911-0489 |
| 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: | Multi-phenolic |
| 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: | Serotonin Hydrochloride, 5-hydroxytryptophan, Acetaldehyde, Acetylcholine Chloride, Apiolum, Ascorbic Acid, Aspartame, Butylated Hydroxytoluene, Caffeic Acid, Chlorogenic Acid, Cinnamic Acid, Coniferyl Alcohol, Coumarinum, Dopamine Hydrochloride, Estradiol, Gallicum Acidum, Gaba (gamma-aminobutyric Acid), Histaminum Hydrochloricum, Hydrocortisone (cortisol), Indolum, L-dopa, L-phenylalanine, Malvin, Mannan, Melatonin, Menadione, Norepinephrine (bitartrate), Octopamine (hydrochloride), Phenyl Isothiocyanate, |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Energique, 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: | .GAMMA.-AMINOBUTYRIC ACID - 6 [hp_X]/mL ACETALDEHYDE - 6 [hp_X]/mL ACETYLCHOLINE CHLORIDE - 6 [hp_X]/mL APIOLE (PARSLEY) - 6 [hp_X]/mL ASCORBIC ACID - 6 [hp_X]/mL ASPARTAME - 6 [hp_X]/mL BUTYLATED HYDROXYTOLUENE - 6 [hp_X]/mL CAFFEIC ACID - 6 [hp_X]/mL CANDIDA ALBICANS - 12 [hp_X]/mL CHLOROGENIC ACID - 6 [hp_X]/mL Load more... CINNAMIC ACID - 6 [hp_X]/mL CONIFERYL ALCOHOL - 6 [hp_X]/mL COUMARIN - 6 [hp_X]/mL DOPAMINE HYDROCHLORIDE - 6 [hp_X]/mL ESTRADIOL - 6 [hp_X]/mL GALLIC ACID MONOHYDRATE - 6 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE - 6 [hp_X]/mL HYDROCORTISONE - 6 [hp_X]/mL INDOLE - 6 [hp_X]/mL LEVODOPA - 6 [hp_X]/mL MALVIN - 6 [hp_X]/mL MELATONIN - 6 [hp_X]/mL MENADIONE - 6 [hp_X]/mL NOREPINEPHRINE BITARTRATE - 6 [hp_X]/mL OCTOPAMINE HYDROCHLORIDE - 6 [hp_X]/mL OXITRIPTAN - 6 [hp_X]/mL PHENYL ISOTHIOCYANATE - 6 [hp_X]/mL PHENYLALANINE - 6 [hp_X]/mL PHLORIZIN - 6 [hp_X]/mL PIPERINE - 6 [hp_X]/mL PROGESTERONE - 6 [hp_X]/mL PYRROLE - 6 [hp_X]/mL QUERCETIN - 6 [hp_X]/mL RUTIN - 6 [hp_X]/mL SALSOLINOL HYDROCHLORIDE - 6 [hp_X]/mL SEROTONIN HYDROCHLORIDE - 4 [hp_X]/mL TAURINE - 6 [hp_X]/mL YEAST MANNAN - 6 [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: | 19 Mar, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 01 Jul, 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: | 20 Jun, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Energique, 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: | N0000193618 M0001797 N0000185372 N0000175629 N0000184306 N0000185001 M0008890 M0000728 M0447348 N0000175825 N0000000100 N0000175576 N0000175450 N0000193220 M0370111 M0017672 N0000175601 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2ACZ6IPC6I GO1N1ZPR3B AF73293C2R QQ67504PXO PQ6CK8PD0R Z0H242BBR1 1P9D0Z171K U2S3A33KVM 4D7G21HDBC 318ADP12RI Load more... U14A832J8D E7SM92591P A4VZ22K1WT 7L3E358N9L 4TI98Z838E 48339473OT 3POA0Q644U WI4X0X7BPJ 8724FJW4M5 46627O600J I9I120531L JL5DK93RCL 723JX6CXY5 IFY5PE3ZRW 37YAS5L9HQ C1LJO185Q9 0D58F84LSU 47E5O17Y3R CU9S17279X U71XL721QK 4G7DS2Q64Y 86S1ZD6L2C 9IKM0I5T1E 5G06TVY3R7 COV48SBC7T GKN429M9VS 1EQV5MLY3D 91R887N59P |
| 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: | Estrogen Receptor Agonists [MoA] Corticosteroid Hormone Receptor Agonists [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: | Vitamin C [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Estrogen [EPC] Corticosteroid [EPC] Aromatic Amino Acid [EPC] Progesterone [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: | Ascorbic Acid [CS] Fungal Proteins [CS] Allergens [CS] Estradiol Congeners [CS] Amino Acids, Aromatic [CS] Progesterone [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: | Allergens [CS] Amino Acids Aromatic [CS] Aromatic Amino Acid [EPC] Ascorbic Acid [CS] Catecholamine [EPC] Catecholamines [CS] Cell-mediated Immunity [PE] Cholinergic Agonists [MoA] Cholinergic Receptor Agonist [EPC] Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC] Estradiol Congeners [CS] Estrogen Receptor Agonists [MoA] Estrogen [EPC] Fungal Proteins [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Non-Standardized Fungal Allergenic Extract [EPC] Progesterone [CS] Progesterone [EPC] Vitamin C [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 44911-0489-1 | 30 mL in 1 BOTTLE, DROPPER (44911-0489-1) | 19 Mar, 2019 | 01 Jul, 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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