| Drug NDC: | 55714-4824 |
| 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: | Neuro-care |
| 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: | Chamomilla, Hypericum Perforatum, Aconitum Napellus, Argentum Nitricum, Arsenicum Album, Belladonna, Bryonia, Cinchona Officinalis, Gelsemium Sempervirens, Hypericum Perforatum, Ignatia Amara, Kalmia Latifolia, Lachesis Mutus, Lycopodium Clavatum, Magnesia Phosphorica, Mezereum, Phosphorus, Pulsatilla, Rhus Toxicodendron, Stramonium, Strychninum, Verbascum Thapsus. |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Newton Laboratories, 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: | ACONITUM NAPELLUS - 15 [hp_X]/mL ANEMONE PULSATILLA - 15 [hp_X]/mL ARSENIC TRIOXIDE - 15 [hp_X]/mL ATROPA BELLADONNA - 15 [hp_X]/mL BRYONIA ALBA ROOT - 15 [hp_X]/mL CINCHONA OFFICINALIS BARK - 15 [hp_X]/mL DAPHNE MEZEREUM BARK - 15 [hp_X]/mL DATURA STRAMONIUM - 15 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT - 15 [hp_X]/mL HYPERICUM PERFORATUM - 15 [hp_X]/mL Load more... KALMIA LATIFOLIA LEAF - 15 [hp_X]/mL LACHESIS MUTA VENOM - 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 15 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 15 [hp_X]/mL MATRICARIA CHAMOMILLA - 6 [hp_X]/mL PHOSPHORUS - 15 [hp_X]/mL SILVER NITRITE - 15 [hp_X]/mL STRYCHNINE - 15 [hp_X]/mL STRYCHNOS IGNATII SEED - 15 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF - 15 [hp_X]/mL VERBASCUM THAPSUS - 15 [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: | 02 Sep, 2019 |
| 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: | Newton Laboratories, 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. | |
| UNII: | U0NQ8555JD I76KB35JEV S7V92P67HO WQZ3G9PF0H T7J046YI2B S003A158SB X2N6E405GV G6W4F0V8Z3 639KR60Q1Q XK4IUX8MNB Load more... 79N6542N18 VSW71SS07I C88X29Y479 HF539G9L3Q G0R4UBI2ZZ 27YLU75U4W T3MZ57OGIF H9Y79VD43J 1NM3M2487K 6IO182RP7A C9TD27U172 |
| 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: | Calculi Dissolution Agent [EPC] 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] 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 |
|---|---|---|---|---|
| 55714-4824-1 | 30 mL in 1 BOTTLE, GLASS (55714-4824-1) | 02 Sep, 2019 | 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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