NDC 57687-244 Rescue Sleep Kids Dropper

Helianthemum Nummularium Flower,Clematis Vitalba Flower,Impatiens Glandulifera - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
57687-244
Proprietary Name:
Rescue Sleep Kids Dropper
Non-Proprietary Name: [1]
Helianthemum Nummularium Flower, Clematis Vitalba Flower, Impatiens Glandulifera Flower, Prunus Cerasifera Flower, Ornithogalum Umbellatum Whole, And Aesculus Hippocastanum Flower
Substance Name: [2]
Aesculus Hippocastanum Flower; Clematis Vitalba Flower; Helianthemum Nummularium Flower; Impatiens Glandulifera Flower; Ornithogalum Umbellatum Whole; Prunus Cerasifera Flower
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Nelson Bach Usa Limited
    Labeler Code:
    57687
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    01-01-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 57687-244-10

    Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

    Product Details

    What is NDC 57687-244?

    The NDC code 57687-244 is assigned by the FDA to the product Rescue Sleep Kids Dropper which is a human over the counter drug product labeled by Nelson Bach Usa Limited. The generic name of Rescue Sleep Kids Dropper is helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum whole, and aesculus hippocastanum flower. The product's dosage form is solution and is administered via oral form. The product is distributed in a single package with assigned NDC code 57687-244-10 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Rescue Sleep Kids Dropper?

    Children age 2 and up: take 4 drops directly on tongue, or add to water and sip at intervals. Additional drops may be taken during the night as needed.children under 2: ask a doctor

    What are Rescue Sleep Kids Dropper Active Ingredients?

    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 Rescue Sleep Kids Dropper UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP)
    • HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (Active Moiety)
    • CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI)
    • CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (Active Moiety)
    • IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV)
    • IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (Active Moiety)
    • PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS)
    • PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (Active Moiety)
    • ORNITHOGALUM UMBELLATUM WHOLE (UNII: 9NS3M2Y78S)
    • ORNITHOGALUM UMBELLATUM WHOLE (UNII: 9NS3M2Y78S) (Active Moiety)
    • AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M)
    • AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (Active Moiety)

    Which are Rescue Sleep Kids Dropper Inactive Ingredients 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:

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".