| Drug NDC: | 55714-2550 |
| 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: | Rheumatic-joint 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: | Uricum Acidum, Aconitum Nap.,apis Mel., Arnica, Arsenicum Alb, Belladonna,benzoicum Acidum, Bryonia, Calc. Carb., Chamomilla, Cinchona, Colchicum, Eupatorium Perf., Gaultheriaprocumbens, Guaiacum, Iodium, Kali Bic, Kalmia,ledum, Pulsatilla, Rhus Toxicodendron, Ruta,sabina, Strychninum, Lappa, Phytolacca, Symphytum, |
| 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 APIS MELLIFERA - 15 [hp_X]/mL ARCTIUM LAPPA ROOT - 6 [hp_X]/mL ARNICA MONTANA - 15 [hp_X]/mL ARSENIC TRIOXIDE - 15 [hp_X]/mL ATROPA BELLADONNA - 15 [hp_X]/mL BENZOIC ACID - 15 [hp_X]/mL BRYONIA ALBA ROOT - 15 [hp_X]/mL CINCHONA OFFICINALIS BARK - 15 [hp_X]/mL Load more... COLCHICUM AUTUMNALE BULB - 15 [hp_X]/mL COMFREY ROOT - 6 [hp_X]/mL EUPATORIUM PERFOLIATUM FLOWERING TOP - 15 [hp_X]/mL GAULTHERIA PROCUMBENS TOP - 15 [hp_X]/mL GUAIACUM OFFICINALE RESIN - 15 [hp_X]/mL IODINE - 15 [hp_X]/mL JUNIPERUS SABINA LEAFY TWIG - 15 [hp_X]/mL KALMIA LATIFOLIA LEAF - 15 [hp_X]/mL MATRICARIA CHAMOMILLA - 15 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE - 15 [hp_X]/mL PHYTOLACCA AMERICANA ROOT - 6 [hp_X]/mL POTASSIUM DICHROMATE - 15 [hp_X]/mL RHODODENDRON TOMENTOSUM LEAFY TWIG - 15 [hp_X]/mL RUTA GRAVEOLENS FLOWERING TOP - 15 [hp_X]/mL STRYCHNINE - 15 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF - 15 [hp_X]/mL URIC ACID - 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: | 01 Jul, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 05 May, 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: | N0000185021 N0000175629 N0000184306 N0000185001 M0000728 M0002274 N0000175806 N0000175807 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | U0NQ8555JD I76KB35JEV 7S82P3R43Z 597E9BI3Z3 O80TY208ZW S7V92P67HO WQZ3G9PF0H 8SKN0B0MIM T7J046YI2B S003A158SB Load more... 993QHL78E6 M9VVZ08EKQ 1W0775VX6E 830295X963 N0K2Z502R6 9679TC07X4 Z5BEX9K2G1 79N6542N18 G0R4UBI2ZZ 2E32821G6I 11E6VI8VEG T4423S18FM 877L01IZ0P N94C2U587S H9Y79VD43J 6IO182RP7A 268B43MJ25 |
| 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: | Ammonium Ion Binding 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: | Standardized Insect Venom Allergenic Extract [EPC] Nitrogen Binding Agent [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: | Allergens [CS] Bee Venoms [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] Ammonium Ion Binding Activity [MoA] Bee Venoms [CS] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Increased IgG Production [PE] Nitrogen Binding Agent [EPC] Standardized Insect Venom Allergenic Extract [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 |
|---|---|---|---|---|
| 55714-2550-0 | 15 mL in 1 BOTTLE, GLASS (55714-2550-0) | 23 Nov, 2021 | N/A | No |
| 55714-2550-1 | 30 mL in 1 BOTTLE, GLASS (55714-2550-1) | 01 Jul, 2019 | N/A | No |
| 55714-2550-2 | 50 mL in 1 BOTTLE, GLASS (55714-2550-2) | 01 Jul, 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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