| Drug NDC: | 64578-0148 |
| 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: | Aller-chord F |
| 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: | Acetaldehyde, Aceticum Ac, Arg Nit, Caffeinum, Calc Sulph, Citricum Ac, Cortisone Aceticum, Echinacea Purp, Folliculinum, Fragaria, Fumaricum Ac, Gallicum Ac, Glandula Suprarenalis Suis, Hepar Suis, Histaminum Hydrochloricum, Hydrangea, Lac Vac, Lecithin, Limulus, Lycopersicum, Lycopodium, Nat Bicarb, Nat Mur, Nux Vom, Paraffinum, Phosphoricum Ac, Saccharum Off, Silicea, Tartaricum Ac, Torula Cerevisiae. |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Energetix Corp |
| 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: | ACETALDEHYDE - 12 [hp_X]/59.1mL ACETIC ACID - 15 [hp_X]/59.1mL ALPINE STRAWBERRY - 15 [hp_X]/59.1mL ANHYDROUS CITRIC ACID - 15 [hp_X]/59.1mL CAFFEINE - 15 [hp_X]/59.1mL CALCIUM SULFATE ANHYDROUS - 15 [hp_X]/59.1mL CORTISONE ACETATE - 20 [hp_X]/59.1mL COW MILK - 15 [hp_X]/59.1mL ECHINACEA PURPUREA - 6 [hp_X]/59.1mL EGG PHOSPHOLIPIDS - 15 [hp_X]/59.1mL Load more... ESTRONE - 15 [hp_X]/59.1mL FUMARIC ACID - 15 [hp_X]/59.1mL GALLIC ACID MONOHYDRATE - 12 [hp_X]/59.1mL HISTAMINE DIHYDROCHLORIDE - 12 [hp_X]/59.1mL HYDRANGEA ARBORESCENS ROOT - 6 [hp_X]/59.1mL LIMULUS POLYPHEMUS - 15 [hp_X]/59.1mL LYCOPODIUM CLAVATUM SPORE - 12 [hp_X]/59.1mL PARAFFIN - 15 [hp_X]/59.1mL PHOSPHORIC ACID - 15 [hp_X]/59.1mL PORK LIVER - 9 [hp_X]/59.1mL SACCHAROMYCES CEREVISIAE - 15 [hp_X]/59.1mL SILICON DIOXIDE - 15 [hp_X]/59.1mL SILVER NITRATE - 10 [hp_X]/59.1mL SODIUM BICARBONATE - 15 [hp_X]/59.1mL SODIUM CHLORIDE - 12 [hp_X]/59.1mL SOLANUM LYCOPERSICUM - 15 [hp_X]/59.1mL STRYCHNOS NUX-VOMICA SEED - 12 [hp_X]/59.1mL SUCROSE - 15 [hp_X]/59.1mL SUS SCROFA ADRENAL GLAND - 9 [hp_X]/59.1mL TARTARIC ACID - 15 [hp_X]/59.1mL |
| 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: | 08 Aug, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 10 Jun, 2026 |
| 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: | Energetix Corp |
| 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 N0000175739 N0000175729 N0000175790 M0023046 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0013890 N0000185372 N0000185001 M0008890 N0000185375 M0016962 M0516536 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | GO1N1ZPR3B Q40Q9N063P CG6IX3GCMU XF417D3PSL 3G6A5W338E E934B3V59H 883WKN7W8X 917J3173FT QI7G114Y98 1Z74184RGV Load more... 2DI9HA706A 88XHZ13131 48339473OT 3POA0Q644U SFK828Q2DE 3R8874KEYH C88X29Y479 I9O0E3H2ZE E4GA8884NN 6EC706HI7F 978D8U419H ETJ7Z6XBU4 95IT3W8JZE 8MDF5V39QO 451W47IQ8X 0243Q4990L 269XH13919 C151H8M554 398IYQ16YV W4888I119H |
| 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] Central Nervous System Stimulant [EPC] Methylxanthine [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [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: | Decreased Coagulation Factor Activity [PE] Central Nervous System Stimulation [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: | Xanthines [CS] Allergens [CS] Dietary Proteins [CS] Milk Proteins [CS] Fungal Proteins [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: | Acidifying Activity [MoA] Allergens [CS] Anti-coagulant [EPC] Blood Coagulation Factor [EPC] Calcium Chelating Activity [MoA] Calcium [CS] Calculi Dissolution Agent [EPC] Cations Divalent [CS] Cell-mediated Immunity [PE] Central Nervous System Stimulant [EPC] Central Nervous System Stimulation [PE] Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC] Decreased Coagulation Factor Activity [PE] Dietary Proteins [CS] Fungal Proteins [CS] Increased Coagulation Factor Activity [PE] Increased Histamine Release [PE] Increased IgG Production [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Methylxanthine [EPC] Milk Proteins [CS] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Plant Proteins [CS] Seed Storage Proteins [CS] Xanthines [CS] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 64578-0148-1 | 59.1 mL in 1 BOTTLE, DROPPER (64578-0148-1) | 28 Apr, 2016 | 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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