Rescue Remedy Kids Spray
NDC 57687-334
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Rescue Remedy Kids (rescue remedy) 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 spray for oral administration. This product entry covers the primary NDC 57687-334 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
57687-334
Proprietary Name:
Rescue Remedy Kids
Non-Proprietary Name: [1]
Rescue Remedy
Substance Name: [2]
Clematis Vitalba Flower; Helianthemum Nummularium Flower; Impatiens Glandulifera Flower; Ornithogalum Umbellatum Flowering Top; Prunus Cerasifera Flower
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Spray
- A liquid minutely divided as by a jet of air or steam.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
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]
09-03-2024
End Marketing Date: [10]
08-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 57687-334?
The NDC code 57687-334 is assigned by the FDA to the product Rescue Remedy Kids. It is commonly known by its generic name, rescue remedy. This pharmaceutical product is labeled by Nelson Bach Usa Limited and is currently categorized as listed product. The medication is a spray administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 57687-334-20. 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?
Directionschildren ages 2 & up: bring spray nozzle up to mouth & apply 2 sprays onto the tongue as needed
children under 2: ask a doctor before use
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI)
- CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (Active Moiety)
- IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV)
- IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (Active Moiety)
- HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP)
- HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (Active Moiety)
- PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS)
- PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (Active Moiety)
- ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B)
- ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (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)
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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 is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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 are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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 End Marketing Date? 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.
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".
