55714-2454 NDC - HEADACHE (ELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..)

Drug Information

  • Product NDC: 55714-2454
  • Proprietary Name: Headache
  • Non Proprietary Name: Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ..
  • Active Ingredient(s): 6 [hp_X]/g APIS MELLIFERA; 15 [hp_X]/g ARABICA COFFEE BEAN; 15 [hp_X]/g ARSENIC TRIOXIDE; 15 [hp_X]/g ATROPA BELLADONNA; 15 [hp_X]/g BLACK COHOSH; 15 [hp_X]/g BRYONIA ALBA ROOT; 15 [hp_X]/g CENTAUREA BENEDICTA; 15 [hp_X]/g CLAVICEPS PURPUREA SCLEROTIUM; 15 [hp_X]/g CONVALLARIA MAJALIS; 15 [hp_X]/g CROTALUS HORRIDUS HORRIDUS VENOM; 15 [hp_X]/g DIGITALIS; 15 [hp_X]/g GELSEMIUM SEMPERVIRENS ROOT; 6 [hp_X]/g HYPERICUM PERFORATUM; 15 [hp_X]/g LACHESIS MUTA VENOM; 15 [hp_X]/g MERCURY; 30 [hp_X]/g MICRURUS CORALLINUS VENOM; 15 [hp_X]/g NAJA NAJA VENOM; 15 [hp_X]/g NITROGLYCERIN; 15 [hp_X]/g PHOSPHORUS; 15 [hp_X]/g SANGUINARIA CANADENSIS ROOT; 15 [hp_X]/g STRYCHNOS IGNATII SEED; 15 [hp_X]/g STRYCHNOS NUX-VOMICA SEED; 6 [hp_X]/g THUJA OCCIDENTALIS LEAFY TWIG; 15 [hp_X]/g TOXICODENDRON PUBESCENS LEAF; 15 [hp_X]/g VIPERA BERUS VENOM
  • Administration Route(s): ORAL
  • Dosage Form(s): PELLET
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Allergens [CS]; Bee Venoms [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Nitrate Vasodilator [EPC]; Nitrates [CS]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Plant Proteins [CS]; Seed Storage Proteins [CS]; Seed Storage Proteins [CS]; Standardized Insect Venom Allergenic Extract [EPC]; Vasodilation [PE]

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:1/31/2019

Package Information

No. Package Code Package Description Billing Unit
155714-2454-128 g in 1 BOTTLE, GLASS (55714-2454-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC55714-2454The 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 NAMEHeadacheThe 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, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ..The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPELLETThe 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 DATE1/31/2019This 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; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CLAVICEPS PURPUREA SCLEROTIUM; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; MERCURY; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; SANGUINARIA CANADENSIS ROOT; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; 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 STRENGTH6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 30; 15; 15; 15; 15; 15; 15; 6; 15; 15 
ACTIVE INGRED UNIT[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 
PHARM CLASSESAllergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vasodilation [PE] 

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

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