| Drug NDC: | 63083-2046 |
| 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: | Pain Formula Drops 2046 |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | Pain Formula Drops |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | 2046 |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. | |
| 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: | Pain Formula Drops |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Professional Complementary Health Formulas |
| 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: | .ALPHA.-TOCOPHEROL - 6 [hp_X]/59mL ACETAMINOPHEN - 6 [hp_X]/59mL ACONITUM NAPELLUS WHOLE - 6 [hp_X]/59mL AMARYLLIS BELLADONNA WHOLE - 6 [hp_X]/59mL ARSENIC TRIOXIDE - 6 [hp_X]/59mL ASCORBIC ACID - 6 [hp_X]/59mL ASPIRIN - 6 [hp_X]/59mL BRYONIA ALBA ROOT - 6 [hp_X]/59mL CAPSICUM - 6 [hp_X]/59mL CAUSTICUM - 6 [hp_X]/59mL Load more... CINCHONA OFFICINALIS BARK - 6 [hp_X]/59mL GINGER - 3 [hp_X]/59mL HYPERICUM PERFORATUM WHOLE - 6 [hp_X]/59mL IBUPROFEN - 6 [hp_X]/59mL SALIX ALBA BARK - 3 [hp_X]/59mL TOXICODENDRON PUBESCENS LEAF - 6 [hp_X]/59mL VITAMIN A - 6 [hp_X]/59mL |
| 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: | 15 Aug, 1984 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 18 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: | Professional Complementary Health Formulas |
| 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: | N0000193618 M0001797 N0000000160 N0000008836 M0001335 N0000175722 N0000175578 N0000008832 N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0022575 M0008672 M0022788 N0000175950 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | H4N855PNZ1 362O9ITL9D U0NQ8555JD 11B89M58UN S7V92P67HO PQ6CK8PD0R R16CO5Y76E T7J046YI2B 00UK7646FG DD5FO1WKFU Load more... S003A158SB C5529G5JPQ XK4IUX8MNB WK2XYI10QM 205MXS71H7 6IO182RP7A 81G40H8B0T |
| 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: | Cyclooxygenase Inhibitors [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: | Vitamin C [EPC] Nonsteroidal Anti-inflammatory Drug [EPC] Platelet Aggregation Inhibitor [EPC] Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Vitamin A [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: | Decreased Prostaglandin Production [PE] Decreased Platelet Aggregation [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: | Ascorbic Acid [CS] Anti-Inflammatory Agents, Non-Steroidal [CS] Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Vegetable Proteins [CS] Food Additives [CS] Vitamin A [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] Anti-Inflammatory Agents Non-Steroidal [CS] Ascorbic Acid [CS] Cell-mediated Immunity [PE] Cyclooxygenase Inhibitors [MoA] Decreased Platelet Aggregation [PE] Decreased Prostaglandin Production [PE] Dietary Proteins [CS] Food Additives [CS] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Nonsteroidal Anti-inflammatory Drug [EPC] Plant Proteins [CS] Platelet Aggregation Inhibitor [EPC] Vegetable Proteins [CS] Vitamin A [CS] Vitamin A [EPC] Vitamin C [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 |
|---|---|---|---|---|
| 63083-2046-2 | 59 mL in 1 BOTTLE, DROPPER (63083-2046-2) | 15 Aug, 1985 | 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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