Bach Hope And Joy Comfort Kit
NDC 57687-315
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Bach Hope And Joy Comfort Kit (star of bethlehem, gorse, sweet chestnut) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Nelson Bach Usa Limited. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit. This product entry covers the primary NDC 57687-315 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
57687-315
Proprietary Name:
Bach Hope And Joy Comfort Kit
Non-Proprietary Name: [1]
Star Of Bethlehem, Gorse, Sweet Chestnut
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Kit
- A packaged collection of related material.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
57687
Product Label ID:
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Marketing Timeline
Start Marketing Date: [9]
11-01-2023
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 57687-315?
The NDC code 57687-315 is assigned by the FDA to the product Bach Hope And Joy Comfort Kit. It is commonly known by its generic name, star of bethlehem, gorse, sweet chestnut. This pharmaceutical product is labeled by Nelson Bach Usa Limited and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 57687-315-30. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
■ single remedies: take 2 drops directly on the tongue or add to a beverage & sip. Repeat as needed throughout the day.
■ children under 2: ask a doctor before use
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B)
- ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (Active Moiety)
- ULEX EUROPAEUS FLOWER (UNII: 398DBS1PXN)
- ULEX EUROPAEUS FLOWER (UNII: 398DBS1PXN) (Active Moiety)
- CASTANEA SATIVA FLOWER (UNII: YHZ719F7M3)
- CASTANEA SATIVA FLOWER (UNII: YHZ719F7M3) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- WATER (UNII: 059QF0KO0R)
- GLYCERIN (UNII: PDC6A3C0OX)
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
