| Drug NDC: | 55714-4790 |
| 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: | Acne - Cystic Acne |
| 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: | Echinacea, Juglans Regia, Lappa Major, Taraxacum Officinale, Antimonium Crudum, Arsenicum Album, Aurum Metallicum, Berberis Aquifolium, Bovista, Carbo Vegetabilis, Causticum, Chelidonium Majus, Dulcamara, Graphites, Hepar Sulphuris Calcareum, Hydrocotyle Asiatica, Kali Bromatum, Kali Iodatum, Ledum Palustre, Lycopdium Clavatum, Nux Vomica, Sulphur Iodatum, Zincum Metallicum, Silicea |
| 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: | ACTIVATED CHARCOAL - 15 [hp_X]/mL ANTIMONY TRISULFIDE - 15 [hp_X]/mL ARCTIUM LAPPA WHOLE - 6 [hp_X]/mL ARSENIC TRIOXIDE - 15 [hp_X]/mL BERBERIS AQUIFOLIUM WHOLE - 15 [hp_X]/mL CALCIUM SULFIDE - 15 [hp_X]/mL CALVATIA GIGANTEA WHOLE - 15 [hp_X]/mL CAUSTICUM - 15 [hp_X]/mL CENTELLA ASIATICA - 15 [hp_X]/mL CHELIDONIUM MAJUS - 15 [hp_X]/mL Load more... ECHINACEA, UNSPECIFIED - 6 [hp_X]/mL GOLD - 15 [hp_X]/mL GRAPHITE - 15 [hp_X]/mL JUGLANS REGIA WHOLE - 6 [hp_X]/mL LEDUM PALUSTRE WHOLE - 15 [hp_X]/mL LYCOPODIUM CLAVATUM WHOLE - 15 [hp_X]/mL POTASSIUM BROMIDE - 15 [hp_X]/mL POTASSIUM IODIDE - 15 [hp_X]/mL SILICON DIOXIDE - 15 [hp_X]/mL SOLANUM DULCAMARA WHOLE - 15 [hp_X]/mL STRYCHNOS NUX-VOMICA WHOLE - 15 [hp_X]/mL SULFUR IODIDE - 15 [hp_X]/mL TARAXACUM OFFICINALE - 6 [hp_X]/mL ZINC - 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: | 16 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: | 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. | |
| NUI: | N0000185508 N0000175629 N0000184306 M0000728 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2P3VWU3H10 F79059A38U 73070DU1LA S7V92P67HO J4WG1JVR05 1MBW07J51Q BR6B7CG29T DD5FO1WKFU 7M867G6T1U 7E889U5RNN Load more... 4N9P6CC1DX 79Y1949PYO 4QQN74LH4O 87EJ76IO83 1N8KG72C5M 005ICF6L27 OSD78555ZM 1C4QK22F9J ETJ7Z6XBU4 G72JA9DHK5 AB2NX17POS L6L8KA2AA0 39981FM375 J41CSQ7QDS |
| 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: | Standardized Chemical Allergen [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] |
| 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: | Allergens [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] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Standardized Chemical Allergen [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 |
|---|---|---|---|---|
| 55714-4790-1 | 30 mL in 1 BOTTLE, GLASS (55714-4790-1) | 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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