| Drug NDC: | 43742-1511 |
| 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: | Oral Health |
| 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: | Borax, Bryonia (alba), Echinacea Purpurea, Juglans Cinerea, Kali Muriaticum, Magnesia Muriatica, Muriaticum Acidum, Discus Intervertebralis Suis, Oral Mucosa (suis), Antimonium Crudum, Arsenicum Album, Bismuthum Subnitricum, Chamomilla, Cinchona Officinalis, Nux Moschata, Sambucus Nigra, Sepia, Mercurius Solubilis, Calcarea Phosphorica, Ignatia Amara, Oxygenium, Candida Albicans |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Deseret Biologicals, 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: | ANTIMONY TRISULFIDE - 12 [hp_X]/mL ARSENIC TRIOXIDE - 12 [hp_X]/mL BISMUTH SUBNITRATE - 12 [hp_X]/mL BRYONIA ALBA ROOT - 6 [hp_X]/mL CANDIDA ALBICANS - 16 [hp_X]/mL CINCHONA OFFICINALIS BARK - 12 [hp_X]/mL ECHINACEA PURPUREA - 6 [hp_X]/mL HYDROCHLORIC ACID - 6 [hp_X]/mL JUGLANS CINEREA BRANCH BARK/ROOT BARK - 6 [hp_X]/mL MAGNESIUM CHLORIDE - 6 [hp_X]/mL Load more... MATRICARIA CHAMOMILLA - 12 [hp_X]/mL MERCURIUS SOLUBILIS - 12 [hp_X]/mL NUTMEG - 12 [hp_X]/mL OXYGEN - 16 [hp_X]/mL POTASSIUM CHLORIDE - 6 [hp_X]/mL SAMBUCUS NIGRA FLOWERING TOP - 12 [hp_X]/mL SEPIA OFFICINALIS JUICE - 12 [hp_X]/mL SODIUM BORATE - 6 [hp_X]/mL STRYCHNOS IGNATII SEED - 12 [hp_X]/mL SUS SCROFA INTERVERTEBRAL DISC - 8 [hp_X]/mL SUS SCROFA ORAL MUCOSA - 8 [hp_X]/mL TRIBASIC CALCIUM PHOSPHATE - 12 [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: | 20 Aug, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 22 Oct, 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: | 10 May, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Deseret Biologicals, 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: | N0000185372 N0000175629 N0000184306 N0000185001 M0008890 M0000728 N0000185371 N0000185375 M0016962 M0006342 M0008672 M0516536 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | F79059A38U S7V92P67HO H19J064BA5 T7J046YI2B 4D7G21HDBC S003A158SB QI7G114Y98 QTT17582CB 48FZ1BHO18 02F3473H9O Load more... G0R4UBI2ZZ 324Y4038G2 AEE24M3MQ9 S88TT14065 660YQ98I10 CT03BSA18U QDL83WN8C2 91MBZ8H3QO 1NM3M2487K OJ17O2WTSM DUP6W562BM 91D9GV0Z28 |
| 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: | Non-Standardized Fungal Allergenic Extract [EPC] Non-Standardized Food 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: | 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: | Fungal Proteins [CS] Allergens [CS] Plant Proteins [CS] Dietary Proteins [CS] Food Additives [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: | Allergens [CS] Bismuth [CS] Bismuth [EPC] Blood Coagulation Factor [EPC] Calcium [CS] Calculi Dissolution Agent [EPC] Cations Divalent [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Food Additives [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] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] 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] Potassium Compounds [CS] Potassium Salt [EPC] Seed Storage Proteins [CS] 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 |
|---|---|---|---|---|
| 43742-1511-1 | 30 mL in 1 BOTTLE, DROPPER (43742-1511-1) | 20 Aug, 2019 | 22 Oct, 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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