| Drug NDC: | 64616-100 |
| 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: | Op-p |
| 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: | Emotional Health Booster |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Vitality Works, 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 LYCOCTONUM - 5 [hp_X]/mL ALOE - 10 [hp_X]/mL ALUMINUM OXIDE - 10 [hp_X]/mL ARSENIC TRIIODIDE - 8 [hp_X]/mL ARSENIC TRIOXIDE - 15 [hp_Q]/mL BLACK COHOSH - 6 [hp_X]/mL BRYONIA ALBA ROOT - 12 [hp_X]/mL CALCIUM OXALATE MONOHYDRATE - 15 [hp_X]/mL DROSERA ROTUNDIFOLIA - 12 [hp_X]/mL ECHINACEA PURPUREA - 6 [hp_X]/mL Load more... GAMBOGE - 12 [hp_X]/mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 10 [hp_X]/mL HYPERICUM PERFORATUM - 5 [hp_X]/mL LACHESIS MUTA VENOM - 15 [hp_X]/mL LOBELIA INFLATA - 6 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 10 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 15 [hp_X]/mL NITRIC ACID - 30 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE - 12 [hp_X]/mL PARAFFIN - 27 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP - 5 [hp_X]/mL PHOSPHORUS - 14 [hp_X]/mL POTASSIUM CARBONATE - 10 [hp_X]/mL POTASSIUM CHLORIDE - 6 [hp_X]/mL PULSATILLA PRATENSIS - 2 [hp_X]/mL SCUTELLARIA LATERIFLORA - 7 [hp_X]/mL SEMECARPUS ANACARDIUM JUICE - 10 [hp_X]/mL SENNA LEAF - 10 [hp_X]/mL SODIUM CHLORIDE - 30 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED - 30 [hp_X]/mL SULFURIC ACID - 10 [hp_X]/mL USTILAGO MAYDIS - 6 [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: | 08 Apr, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 16 Jan, 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: | Vitality Works, 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: | N0000185375 N0000175629 N0000184306 N0000185001 M0000728 M0016962 M0516536 N0000185372 M0008890 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | EX75Q30TX6 V5VD430YW9 LMI26O6933 3029988O2T S7V92P67HO K73E24S6X9 T7J046YI2B 4PP86KK527 QR44N9XPJQ QI7G114Y98 Load more... 7556HJ7587 T7S323PKJS XK4IUX8MNB VSW71SS07I 9PP1T3TC5U C88X29Y479 HF539G9L3Q 411VRN1TV4 2E32821G6I I9O0E3H2ZE CLF5YFS11O 27YLU75U4W BQN1B9B9HA 660YQ98I10 8E272251DI 7BP4DH5PDC Y0F0BU8RDU AK7JF626KX 451W47IQ8X 269XH13919 O40UQP6WCF 4K7Z7K7SWG |
| 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 Plant Allergenic Extract [EPC] Non-Standardized Fungal 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: | Allergens [CS] Plant Proteins [CS] Seed Storage Proteins [CS] Fungal 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] Blood Coagulation Factor [EPC] Calcium [CS] Calculi Dissolution Agent [EPC] Cations Divalent [CS] Cell-mediated Immunity [PE] 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 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 |
|---|---|---|---|---|
| 64616-100-02 | 59 mL in 1 BOTTLE, DROPPER (64616-100-02) | 08 Apr, 2013 | 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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