B11 Solution/ Drops
NDC 63479-0211
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
B11 (aristolochia milhomens, arnica montana, arsenicum album, belladonna, bellis perennis, bryonia, calendula officinalis, carbo vegetabilis, chamomilla, cherry plum flower, clematis vitalba flower, echinacea angustifolia, hamamelis virginiana, hepar sulphuris calcareum, hypericum perforatum, impatiens glandulifera flower, lachesis mutus, millefolium, pyrenees star of bethlehem, rhus toxicodendron, rockrose flower, ruta graveolens, sarcolacticum acidum, sulphur iodatum, symphytum officinale, veratrum album) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Apex Energetics Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a solution/ drops for sublingual administration. This product entry covers the primary NDC 63479-0211 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
63479-0211
Proprietary Name:
B11 Injurotox
Non-Proprietary Name: [1]
Aristolochia Milhomens, Arnica Montana, Arsenicum Album, Belladonna, Bellis Perennis, Bryonia, Calendula Officinalis, Carbo Vegetabilis, Chamomilla, Cherry Plum Flower, Clematis Vitalba Flower, Echinacea Angustifolia, Hamamelis Virginiana, Hepar Sulphuris Calcareum, Hypericum Perforatum, Impatiens Glandulifera Flower, Lachesis Mutus, Millefolium, Pyrenees Star Of Bethlehem, Rhus Toxicodendron, Rockrose Flower, Ruta Graveolens, Sarcolacticum Acidum, Sulphur Iodatum, Symphytum Officinale, Veratrum Album
Substance Name: [2]
Aristolochia Cymbifera Flower; Arnica Montana; Arsenic Trioxide; Bellis Perennis; Achillea Millefolium; Ruta Graveolens Flowering Top; Lactic Acid, L-; Activated Charcoal; Matricaria Chamomilla; Prunus Cerasifera Flower; Clematis Vitalba Flower; Echinacea Angustifolia; Helianthemum Nummularium Flower; Comfrey Root; Veratrum Album Root; Ornithogalum Umbellatum Flowering Top; Toxicodendron Pubescens Leaf; Atropa Belladonna; Calendula Officinalis Flowering Top; Hamamelis Virginiana Root Bark/stem Bark; Calcium Sulfide; Lachesis Muta Venom; Sulfur Iodide; Bryonia Alba Root; Hypericum Perforatum; Impatiens Glandulifera Flower
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Solution/ Drops
- A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
Sublingual - Administration beneath the tongue.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
63479
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]
12-15-1994
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 63479-0211?
The NDC code 63479-0211 is assigned by the FDA to the product B11 Injurotox. It is commonly known by its generic name, aristolochia milhomens, arnica montana, arsenicum album, belladonna, bellis perennis, bryonia, calendula officinalis, carbo vegetabilis, chamomilla, cherry plum flower, clematis vitalba flower, echinacea angustifolia, hamamelis virginiana, hepar sulphuris calcareum, hypericum perforatum, impatiens glandulifera flower, lachesis mutus, millefolium, pyrenees star of bethlehem, rhus toxicodendron, rockrose flower, ruta graveolens, sarcolacticum acidum, sulphur iodatum, symphytum officinale, veratrum album. This pharmaceutical product is labeled by Apex Energetics Inc. and is currently categorized as listed product. The medication is a solution/ drops administered via sublingual route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 63479-0211-1. 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: Take10 drops under the tongue 3 times a day, or 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.
- ARISTOLOCHIA CYMBIFERA FLOWER 1 [hp_X]/mL
- ARNICA MONTANA 12 [hp_X]/mL
- ARSENIC TRIOXIDE 9 [hp_X]/mL - An inorganic compound with the chemical formula As2O3 that is used for the treatment of ACUTE PROMYELOCYTIC LEUKEMIA in patients who have relapsed from, or are resistant to, conventional drug therapy.
- BELLIS PERENNIS 100 [hp_X]/mL
- ACHILLEA MILLEFOLIUM 30 [hp_X]/mL - A plant genus of the family ASTERACEAE that has long been used in folk medicine for treating wounds.
- RUTA GRAVEOLENS FLOWERING TOP 8 [hp_X]/mL
- LACTIC ACID, L- 1 [hp_X]/mL
- ACTIVATED CHARCOAL 30 [hp_X]/mL
- MATRICARIA CHAMOMILLA 30 [hp_X]/mL
- PRUNUS CERASIFERA FLOWER 1 [hp_X]/mL
- CLEMATIS VITALBA FLOWER 9 [hp_X]/mL
- ECHINACEA ANGUSTIFOLIA 2 [hp_X]/mL - A genus of perennial herbs used topically and internally. It contains echinacoside, GLYCOSIDES; INULIN; isobutyl amides, resin, and SESQUITERPENES.
- HELIANTHEMUM NUMMULARIUM FLOWER 1 [hp_X]/mL
- COMFREY ROOT 1 [hp_X]/mL
- VERATRUM ALBUM ROOT 9 [hp_X]/mL
- ORNITHOGALUM UMBELLATUM FLOWERING TOP 3 [hp_X]/mL
- TOXICODENDRON PUBESCENS LEAF 9 [hp_X]/mL
- ATROPA BELLADONNA 30 [hp_X]/mL - A plant species of the genus ATROPA, family SOLANACEAE that contains ATROPINE; SCOPOLAMINE; BELLADONNA ALKALOIDS and other SOLANACEOUS ALKALOIDS. Some species in this genus are called deadly nightshade which is also a common name for SOLANUM.
- CALENDULA OFFICINALIS FLOWERING TOP 30 [hp_X]/mL
- HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 30 [hp_X]/mL
- CALCIUM SULFIDE 9 [hp_X]/mL - RN given refers to parent cpd; see also record for lime sulfur (calcium polysulfide)
- LACHESIS MUTA VENOM 9 [hp_X]/mL
- SULFUR IODIDE 3 [hp_X]/mL
- BRYONIA ALBA ROOT 12 [hp_X]/mL
- HYPERICUM PERFORATUM 30 [hp_X]/mL
- IMPATIENS GLANDULIFERA FLOWER 12 [hp_X]/mL
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- ARISTOLOCHIA CYMBIFERA FLOWER (UNII: R06VWT372T)
- ARISTOLOCHIA CYMBIFERA FLOWER (UNII: R06VWT372T) (Active Moiety)
- ARNICA MONTANA (UNII: O80TY208ZW)
- ARNICA MONTANA (UNII: O80TY208ZW) (Active Moiety)
- ARSENIC TRIOXIDE (UNII: S7V92P67HO)
- ARSENIC CATION (3+) (UNII: C96613F5AV) (Active Moiety)
- BELLIS PERENNIS (UNII: 2HU33I03UY)
- BELLIS PERENNIS (UNII: 2HU33I03UY) (Active Moiety)
- ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
- ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK) (Active Moiety)
- RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S)
- RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (Active Moiety)
- LACTIC ACID, L- (UNII: F9S9FFU82N)
- LACTIC ACID, L- (UNII: F9S9FFU82N) (Active Moiety)
- COMFREY ROOT (UNII: M9VVZ08EKQ)
- COMFREY ROOT (UNII: M9VVZ08EKQ) (Active Moiety)
- IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV)
- IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (Active Moiety)
- ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
- ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (Active Moiety)
- MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
- MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (Active Moiety)
- PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS)
- PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (Active Moiety)
- CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI)
- CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (Active Moiety)
- ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
- ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (Active Moiety)
- HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP)
- HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (Active Moiety)
- VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z)
- VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (Active Moiety)
- ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B)
- ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (Active Moiety)
- TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A)
- TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (Active Moiety)
- ATROPA BELLADONNA (UNII: WQZ3G9PF0H)
- ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (Active Moiety)
- CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
- CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (Active Moiety)
- HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
- HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (Active Moiety)
- CALCIUM SULFIDE (UNII: 1MBW07J51Q)
- CALCIUM SULFIDE (UNII: 1MBW07J51Q) (Active Moiety)
- LACHESIS MUTA VENOM (UNII: VSW71SS07I)
- LACHESIS MUTA VENOM (UNII: VSW71SS07I) (Active Moiety)
- SULFUR IODIDE (UNII: L6L8KA2AA0)
- SULFUR IODIDE (UNII: L6L8KA2AA0) (Active Moiety)
- BRYONIA ALBA ROOT (UNII: T7J046YI2B)
- BRYONIA ALBA ROOT (UNII: T7J046YI2B) (Active Moiety)
- HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
- HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (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:
- ALCOHOL (UNII: 3K9958V90M)
- WATER (UNII: 059QF0KO0R)
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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".
