55714-4858 NDC - EDEMA (ELAPS CORALLINUS, APIS MEL., ARSENICUM ALB., CANTHARIS, CINCHONA, COLCHICUM, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, JUNIPERUS COM., LACHESIS, MERC. VIV., NAJA, NAT. CARB., NAT.SULPHURICUM, RHUS TOXICODENDRON, SAMBUCUS NIG., STROPHANTHUS HISPIDUS, THUJA OCC., VIPERA BERUS, ECHINACEA, LAPPA, SOLIDAGO, TARAXACUM, URTICA UR.)

Drug Information

  • Product NDC: 55714-4858
  • Proprietary Name: Edema
  • Non Proprietary Name: Elaps corallinus, Apis mel., Arsenicum alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus horridus, Digitalis, Juniperus com., Lachesis, Merc. viv., Naja, Nat. carb., Nat.sulphuricum, Rhus toxicodendron, Sambucus nig., Strophanthus hispidus, Thuja occ., Vipera berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica ur.
  • Active Ingredient(s): 20 [hp_X]/mL APIS MELLIFERA; 11 [hp_X]/mL ARCTIUM LAPPA ROOT; 20 [hp_X]/mL ARSENIC TRIOXIDE; 20 [hp_X]/mL CINCHONA OFFICINALIS BARK; 20 [hp_X]/mL COLCHICUM AUTUMNALE BULB; 20 [hp_X]/mL CONVALLARIA MAJALIS; 20 [hp_X]/mL CROTALUS HORRIDUS HORRIDUS VENOM; 20 [hp_X]/mL DIGITALIS; 11 [hp_X]/mL ECHINACEA, UNSPECIFIED; 20 [hp_X]/mL JUNIPER BERRY; 20 [hp_X]/mL LACHESIS MUTA VENOM; 20 [hp_X]/mL LYTTA VESICATORIA; 20 [hp_X]/mL MERCURY; 35 [hp_X]/mL MICRURUS CORALLINUS VENOM; 20 [hp_X]/mL NAJA NAJA VENOM; 20 [hp_X]/mL SAMBUCUS NIGRA FLOWERING TOP; 20 [hp_X]/mL SODIUM CARBONATE; 20 [hp_X]/mL SODIUM SULFATE; 11 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP; 20 [hp_X]/mL STROPHANTHUS HISPIDUS SEED; 11 [hp_X]/mL TARAXACUM OFFICINALE; 20 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG; 20 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF; 11 [hp_X]/mL URTICA URENS; 21 [hp_X]/mL VIPERA BERUS VENOM
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Bee Venoms [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Food Additives [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Standardized Insect Venom Allergenic Extract [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Newton Laboratories, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:3/26/2024

Package Information

No. Package Code Package Description Billing Unit
155714-4858-130 mL in 1 BOTTLE, GLASS (55714-4858-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC55714-4858The 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 NAMEEdemaThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEElaps corallinus, Apis mel., Arsenicum alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus horridus, Digitalis, Juniperus com., Lachesis, Merc. viv., Naja, Nat. carb., Nat.sulphuricum, Rhus toxicodendron, Sambucus nig., Strophanthus hispidus, Thuja occ., Vipera berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica ur.The 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 DATE3/26/2024This 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 NAMENewton Laboratories, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAPIS MELLIFERA; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; JUNIPER BERRY; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MERCURY; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; SAMBUCUS NIGRA FLOWERING TOP; SODIUM CARBONATE; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; VIPERA BERUS VENOMAn 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 STRENGTH20; 11; 20; 20; 20; 20; 20; 20; 11; 20; 20; 20; 20; 35; 20; 20; 20; 20; 11; 20; 11; 20; 20; 11; 21 
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 
PHARM CLASSESAllergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC] 

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This page was last updated on: 7/4/2025

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