63479-0221 NDC - 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)

Drug Information

  • Product NDC: 63479-0221
  • Proprietary Name: B21
  • Non Proprietary 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
  • Active Ingredient(s): 3 [hp_X]/mL ACHILLEA MILLEFOLIUM; 30 [hp_X]/mL ACONITUM NAPELLUS; 12 [hp_X]/mL APIS MELLIFERA; 30 [hp_X]/mL ARNICA MONTANA; 15 [hp_X]/mL ARSENIC TRIOXIDE; 30 [hp_X]/mL ATROPA BELLADONNA; 12 [hp_X]/mL BELLIS PERENNIS; 12 [hp_X]/mL BRYONIA ALBA ROOT; 9 [hp_X]/mL CALENDULA OFFICINALIS FLOWERING TOP; 8 [hp_X]/mL CITRULLUS COLOCYNTHIS FRUIT PULP; 30 [hp_X]/mL CLEMATIS VITALBA FLOWER; 6 [hp_X]/mL COMFREY ROOT; 6 [hp_X]/mL ECHINACEA ANGUSTIFOLIA; 6 [hp_X]/mL ECHINACEA PURPUREA; 8 [hp_X]/mL EUPATORIUM PERFOLIATUM FLOWERING TOP; 15 [hp_X]/mL FERROSOFERRIC PHOSPHATE; 3 [hp_X]/mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; 30 [hp_X]/mL HELIANTHEMUM NUMMULARIUM FLOWER; 12 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE; 6 [hp_X]/mL HYPERICUM PERFORATUM; 30 [hp_X]/mL IMPATIENS GLANDULIFERA FLOWER; 1 [hp_X]/mL LEDUM PALUSTRE TWIG; 8 [hp_X]/mL MATRICARIA CHAMOMILLA WHOLE; 1 [hp_X]/mL MENTHA PIPERITA; 30 [hp_X]/mL ORNITHOGALUM UMBELLATUM FLOWERING TOP; 1 [hp_X]/mL PLANTAGO MAJOR; 30 [hp_X]/mL PRUNUS CERASIFERA FLOWER; 8 [hp_X]/mL SOLANUM DULCAMARA WHOLE; 9 [hp_C]/mL SULFUR; 12 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF; 30 [hp_X]/mL VERATRUM ALBUM ROOT; 1 [hp_X]/mL VERBASCUM THAPSUS
  • Administration Route(s): SUBLINGUAL
  • Dosage Form(s): SPRAY
  • Pharmacy Class(es): Allergens [CS]; Bee Venoms [CS]; Cell-mediated Immunity [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Standardized Insect Venom Allergenic Extract [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Apex Energetics Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:5/15/2024

Package Information

No. Package Code Package Description Billing Unit
163479-0221-160 mL in 1 BOTTLE, SPRAY (63479-0221-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC63479-0221The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEB21The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXACUTE RESCUEA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEACONITUM 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 THAPSUSThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESPRAYThe translation of the dosage form Code submitted by the firm.
ROUTE NAMESUBLINGUALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/15/2024This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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.
LABELER NAMEApex Energetics Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACHILLEA 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 THAPSUSAn 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.
ACTIVE NUMERATOR STRENGTH3; 30; 12; 30; 15; 30; 12; 12; 9; 8; 30; 6; 6; 6; 8; 15; 3; 30; 12; 6; 30; 1; 8; 1; 30; 1; 30; 8; 9; 12; 30; 1 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC] 

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This page was last updated on: 6/6/2025

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