| Drug NDC: | 63083-1008 |
| 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: | Flowers 1008 |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | Flowers |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | 1008 |
| 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: | Flowers |
| 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: | ANTIRRHINUM MAJUS LEAF - 6 [hp_X]/59mL BEEF LIVER - 6 [hp_X]/59mL C12-17 ALKANE - 6 [hp_X]/59mL CALENDULA OFFICINALIS FLOWERING TOP - 6 [hp_X]/59mL CAMELLIA CHEKIANGOLEOSA SEED OIL - 6 [hp_X]/59mL CORTICOTROPIN - 6 [hp_X]/59mL DELPHINIUM AJACIS SEED - 6 [hp_X]/59mL DIANTHUS CARYOPHYLLUS WHOLE - 6 [hp_X]/59mL DIANTHUS SUPERBUS FLOWERING TOP - 6 [hp_X]/59mL ESCHSCHOLZIA CALIFORNICA FLOWERING TOP - 6 [hp_X]/59mL Load more... GARDENIA JASMINOIDES FRUIT - 6 [hp_X]/59mL GENTIANA LUTEA ROOT - 6 [hp_X]/59mL GLADIOLUS COMMUNIS WHOLE - 6 [hp_X]/59mL HEDYCHIUM FLAVESCENS WHOLE - 6 [hp_X]/59mL HISTAMINE DIHYDROCHLORIDE - 12 [hp_X]/59mL KALIMERIS INDICA WHOLE - 6 [hp_X]/59mL LIRIODENDRON TULIPIFERA WHOLE - 6 [hp_X]/59mL LONICERA CANADENSIS WHOLE - 6 [hp_X]/59mL LUPINUS ELEGANS WHOLE - 6 [hp_X]/59mL NARCISSUS POETICUS WHOLE - 6 [hp_X]/59mL NERIUM OLEANDER WHOLE - 6 [hp_X]/59mL PAEONIA X SUFFRUTICOSA SEED - 6 [hp_X]/59mL RUELLIA SIMPLEX WHOLE - 6 [hp_X]/59mL SEDUM ROSEUM WHOLE - 6 [hp_X]/59mL SUS SCROFA ADRENAL GLAND - 6 [hp_X]/59mL SYMPHYOTRICHUM OBLONGIFOLIUM WHOLE - 6 [hp_X]/59mL TOWNSENDIA EXSCAPA WHOLE - 6 [hp_X]/59mL VIOLA TRICOLOR WHOLE - 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: | 09 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: | N0000185371 N0000175629 N0000184306 M0000728 M0006342 N0000185017 M0000499 N0000175941 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 339W5OG02M W8N8R55022 FW7807707B 18E7415PXQ 0V564J05CA K0U68Q2TXA 2G74ILK8G4 C0WFO26M8D 1178E5679M 023XWA119J Load more... 7CTH8MD549 S72O3284MS FEL92NE7KH 00AOG6IRLE 3POA0Q644U 0E250104F5 0601Z4Z0LU 0J28O82L6I 1162N20M3O 0C28EK6VVG JG9V5H8412 0I353W9H7M 25B9S57F3D RH0WP583U3 398IYQ16YV 0005633KTU 02AI5I027Q 9Q24RAI43V |
| 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 Food Allergenic Extract [EPC] Adrenocorticotropic Hormone [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] |
| 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] Dietary Proteins [CS] Adrenocorticotropic Hormone [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] Meat Proteins [EXT] Non-Standardized Food 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 |
|---|---|---|---|---|
| 63083-1008-2 | 59 mL in 1 BOTTLE, DROPPER (63083-1008-2) | 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.