43857-0395 NDC - EDEMAFORCE (CACTUS GRANDIFLORUS, CALENDULA OFFICINALIS, DULCAMARA, LEPTANDRA VIRGINICA, SOLIDAGO VIRGAUREA, CONVALLARIA MAJALIS, APIS MELLIFICA, ARNICA MONTANA, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PLUMBUM METALLICUM, SAMBUCUS NIGRA)

Drug Information

  • Product NDC: 43857-0395
  • Proprietary Name: Edemaforce
  • Non Proprietary Name: Cactus Grandiflorus, Calendula Officinalis, Dulcamara, Leptandra Virginica, Solidago Virgaurea, Convallaria Majalis, Apis Mellifica, Arnica Montana, Berberis Vulgaris, Bryonia (Alba), Chelidonium Majus, Lycopodium Clavatum, Plumbum Metallicum, Sambucus Nigra
  • Active Ingredient(s): 12 [hp_X]/mL APIS MELLIFERA; 12 [hp_X]/mL ARNICA MONTANA; 12 [hp_X]/mL BERBERIS VULGARIS ROOT BARK; 12 [hp_X]/mL BRYONIA ALBA ROOT; 3 [hp_X]/mL CALENDULA OFFICINALIS FLOWERING TOP; 12 [hp_X]/mL CHELIDONIUM MAJUS; 4 [hp_X]/mL CONVALLARIA MAJALIS; 12 [hp_X]/mL LEAD; 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE; 12 [hp_X]/mL SAMBUCUS NIGRA FLOWERING TOP; 3 [hp_X]/mL SELENICEREUS GRANDIFLORUS STEM; 3 [hp_X]/mL SOLANUM DULCAMARA TOP; 3 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP; 3 [hp_X]/mL VERONICASTRUM VIRGINICUM ROOT
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • 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: BioActive Nutritional, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:5/31/2016

Package Information

No. Package Code Package Description Billing Unit
143857-0395-130 mL in 1 BOTTLE, DROPPER (43857-0395-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC43857-0395The 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 NAMEEdemaforceThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECactus Grandiflorus, Calendula Officinalis, Dulcamara, Leptandra Virginica, Solidago Virgaurea, Convallaria Majalis, Apis Mellifica, Arnica Montana, Berberis Vulgaris, Bryonia (Alba), Chelidonium Majus, Lycopodium Clavatum, Plumbum Metallicum, Sambucus NigraThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/31/2016This 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 NAMEBioActive Nutritional, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAPIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; CONVALLARIA MAJALIS; LEAD; LYCOPODIUM CLAVATUM SPORE; SAMBUCUS NIGRA FLOWERING TOP; SELENICEREUS GRANDIFLORUS STEM; SOLANUM DULCAMARA TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; VERONICASTRUM VIRGINICUM ROOTAn 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 STRENGTH12; 12; 12; 12; 3; 12; 4; 12; 12; 12; 3; 3; 3; 3 
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 
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: 12/6/2025

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