B21 Spray
NDC 63479-0221

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 63479-0221?
  4. B21 Acute Rescue Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

B21 (aconitum napellus,apis mellifica,arnica montana,arsenicum album,belladonna,bellis perennis,bryonia,calendula officinalis,chamomilla,cherry plum,clematis vitalba,colocynthis,comfrey,dulcamara lignosa,echinacea angustifolia,echinacea purpurea,eupatorium perfoliatum,ferrum phosphoricum,hamamelis virginiana,histaminum,hypericum perforatum,impatiens glandulifera,ledum palustre,mentha piperita,millefolium,ornithogalum umbellatum,plantago major,rhus toxicodendron,rockrose,sulphur,veratrum album,verbascum thapsus) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Apex Energetics Inc.. This medication is typically used as a allergens [cs]. It is supplied as a spray for sublingual administration. This product entry covers the primary NDC 63479-0221 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
63479-0221
Proprietary Name:
B21 Acute Rescue
Non-Proprietary Name: [1]
Aconitum Napellus, Apis Mellifica, Arnica Montana, Arsenicum Album, Belladonna, Bellis Perennis, Bryonia, Calendula Officinalis, Chamomilla, Cherry Plum, Clematis Vitalba, Colocynthis, Comfrey, Dulcamara Lignosa, Echinacea Angustifolia, Echinacea Purpurea, Eupatorium Perfoliatum, Ferrum Phosphoricum, Hamamelis Virginiana, Histaminum, Hypericum Perforatum, Impatiens Glandulifera, Ledum Palustre, Mentha Piperita, Millefolium, Ornithogalum Umbellatum, Plantago Major, Rhus Toxicodendron, Rockrose, Sulphur, Veratrum Album, Verbascum Thapsus
Substance Name: [2]
Achillea Millefolium; Aconitum Napellus; Apis Mellifera; Arnica Montana; Arsenic Trioxide; Atropa Belladonna; Bellis Perennis; Bryonia Alba Root; Calendula Officinalis Flowering Top; Citrullus Colocynthis Fruit Pulp; Clematis Vitalba Flower; Comfrey Root; Echinacea Angustifolia; Echinacea Purpurea; Eupatorium Perfoliatum Flowering Top; Ferrosoferric Phosphate; Hamamelis Virginiana Root Bark/stem Bark; Helianthemum Nummularium Flower; Histamine Dihydrochloride; Hypericum Perforatum; Impatiens Glandulifera Flower; Ledum Palustre Twig; Matricaria Chamomilla Whole; Mentha Piperita; Ornithogalum Umbellatum Flowering Top; Plantago Major; Prunus Cerasifera Flower; Solanum Dulcamara Whole; Sulfur; Toxicodendron Pubescens Leaf; Veratrum Album Root; Verbascum Thapsus
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]
Sublingual - Administration beneath the tongue.

Labeler & Regulatory Data

Labeler Name: [5]
Apex Energetics Inc.
Labeler Code:
63479
Product Label ID:
16c76a4d-7085-f8f5-e063-6294a90a5b37
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
05-15-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 63479-0221?

The NDC code 63479-0221 is assigned by the FDA to the product B21 Acute Rescue. It is commonly known by its generic name, aconitum napellus, apis mellifica, arnica montana, arsenicum album, belladonna, bellis perennis, bryonia, calendula officinalis, chamomilla, cherry plum, clematis vitalba, colocynthis, comfrey, dulcamara lignosa, echinacea angustifolia, echinacea purpurea, eupatorium perfoliatum, ferrum phosphoricum, hamamelis virginiana, histaminum, hypericum perforatum, impatiens glandulifera, ledum palustre, mentha piperita, millefolium, ornithogalum umbellatum, plantago major, rhus toxicodendron, rockrose, sulphur, veratrum album, verbascum thapsus. This pharmaceutical product is labeled by Apex Energetics Inc. and is currently categorized as listed product. The medication is a spray administered via sublingual route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 63479-0221-1. 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?

Adults & children ages 12 years and over: Take 2-3 sprays orally, or topically as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

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:

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:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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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 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".