| Drug NDC: | 63083-1022 |
| 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: | Tropical 1022 |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | Tropical |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | 1022 |
| 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: | Tropical |
| 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: | ACACIA - 6 [hp_X]/59mL AMARANTHUS HYBRIDUS LEAF - 6 [hp_X]/59mL AMBROSIA ARTEMISIIFOLIA WHOLE - 6 [hp_X]/59mL ATRIPLEX POLYCARPA WHOLE - 6 [hp_X]/59mL BEEF LIVER - 6 [hp_X]/59mL CORTICOTROPIN - 6 [hp_X]/59mL CYNODON DACTYLON WHOLE - 6 [hp_X]/59mL EUCALYPTUS GUM - 6 [hp_X]/59mL HISTAMINE DIHYDROCHLORIDE - 12 [hp_X]/59mL JUNIPERUS SCOPULORUM POLLEN - 6 [hp_X]/59mL Load more... OLEA EUROPAEA FLOWER - 6 [hp_X]/59mL PLANTAGO LANCEOLATA LEAF - 6 [hp_X]/59mL POA PRATENSIS TOP - 6 [hp_X]/59mL SUS SCROFA ADRENAL GLAND - 6 [hp_X]/59mL SYAGRUS ROMANZOFFIANA WHOLE - 6 [hp_X]/59mL WHITE MULBERRY - 6 [hp_X]/59mL XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - 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: | 06 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: | 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: | N0000185375 N0000175629 N0000184306 N0000185001 M0016962 M0000728 N0000185371 M0006342 N0000185017 M0000499 N0000175941 N0000185367 M0017130 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 5C5403N26O 07L86FJ69J 9W34L2CQ9A 12IGX5TK1H W8N8R55022 K0U68Q2TXA 2Q8MR21NHK 72T9EZC2VX 3POA0Q644U 0G82TT8ZFY Load more... 498M34P1VZ 2YWL9J7EE8 7EA48700V9 398IYQ16YV 3I21564JAW MN25R0HH5A 0ZK6G3W3BI |
| 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 Food Allergenic Extract [EPC] Adrenocorticotropic Hormone [EPC] Non-Standardized Pollen 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: | Plant Proteins [CS] Allergens [CS] Dietary Proteins [CS] Adrenocorticotropic Hormone [CS] Pollen [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: | Adrenocorticotropic Hormone [CS] Adrenocorticotropic Hormone [EPC] Allergens [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Meat Proteins [EXT] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Pollen Allergenic Extract [EPC] Plant Proteins [CS] Pollen [CS] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 63083-1022-2 | 59 mL in 1 BOTTLE, DROPPER (63083-1022-2) | 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. | ||||
* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.