| Drug NDC: | 81183-103 |
| 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: | The Flower Remedy Happy Heart |
| 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: | Gentianella Amarella, Ulex Europaeus, Ilex Aquifolium, Lonicera Caprifolium, Sinapis Arvensis, Ornithogalum Umbellatum, Castanea Sativa, Salix Vitellina, Ignatia Amara, Natrum Muriaticum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | The Flower Remedy |
| 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: | CASTANEA SATIVA FLOWER - 5 [hp_X]/30mL GENTIANELLA AMARELLA FLOWER - 5 [hp_X]/30mL ILEX AQUIFOLIUM FLOWERING TOP - 5 [hp_X]/30mL LONICERA CAPRIFOLIUM FLOWERING TOP - 5 [hp_X]/30mL ORNITHOGALUM UMBELLATUM FLOWERING TOP - 5 [hp_X]/30mL SALIX ALBA FLOWERING TOP - 5 [hp_X]/30mL SINAPIS ARVENSIS FLOWERING/FRUITING TOP - 5 [hp_X]/30mL SODIUM CHLORIDE - 200 [hp_C]/30mL STRYCHNOS IGNATII SEED - 200 [hp_C]/30mL ULEX EUROPAEUS FLOWER - 5 [hp_X]/30mL |
| 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: | 26 Apr, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 22 Dec, 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: | The Flower Remedy |
| 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. | |
| UPC: | 0709930994570 |
| UPC stands for Universal Product Code. | |
| UNII: | YHZ719F7M3 ZKH2SOY1AR 5ENR9SAN1W 1X0T378SXY CZD6M4PY4B XBP5X7E70R WWX61E1ZAK 451W47IQ8X 1NM3M2487K 398DBS1PXN |
| 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. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 81183-103-30 | 30 mL in 1 BOTTLE, GLASS (81183-103-30) | 26 Apr, 2021 | 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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