43857-0488 NDC - HEADACHE (MELILOTUS OFFICINALIS, SPIGELIA ANTHELMIA, ALLIUM CEPA, BELLADONNA, BRYONIA (ALBA), CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, SANGUINARIA CANADENSIS, SILICEA, TARENTULA CUBENSIS)

Drug Information

  • Product NDC: 43857-0488
  • Proprietary Name: Headache
  • Non Proprietary Name: Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia (Alba), Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis
  • Active Ingredient(s): 12 [hp_X]/mL ATROPA BELLADONNA; 12 [hp_X]/mL BLACK COHOSH; 12 [hp_X]/mL BRYONIA ALBA ROOT; 12 [hp_X]/mL CITHARACANTHUS SPINICRUS; 12 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT; 12 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; 3 [hp_X]/mL MELILOTUS OFFICINALIS TOP; 12 [hp_X]/mL NITROGLYCERIN; 12 [hp_X]/mL ONION; 12 [hp_X]/mL SANGUINARIA CANADENSIS ROOT; 12 [hp_X]/mL SILICON DIOXIDE; 6 [hp_X]/mL SPIGELIA ANTHELMIA WHOLE; 12 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Calculi Dissolution Agent [EPC]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Nitrate Vasodilator [EPC]; Nitrates [CS]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Plant Proteins [CS]; Seed Storage Proteins [CS]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]; Vasodilation [PE]; Vegetable Proteins [CS]

Labeler Information

Field Name Field Value
Labeler Name: BioActive Nutritionals, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:7/19/2018

Package Information

No. Package Code Package Description Billing Unit
143857-0488-130 mL in 1 BOTTLE, DROPPER (43857-0488-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC43857-0488The 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 NAMEMelilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia (Alba), Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula CubensisThe 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 DATE7/19/2018This 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 Nutritionals, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CITHARACANTHUS SPINICRUS; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MELILOTUS OFFICINALIS TOP; NITROGLYCERIN; ONION; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; SPIGELIA ANTHELMIA WHOLE; STRYCHNOS NUX-VOMICA SEEDAn 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; 12; 12; 3; 12; 12; 12; 12; 6; 12 
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 
PHARM CLASSESAllergens [CS], Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vasodilation [PE], Vegetable Proteins [CS] 

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This page was last updated on: 12/6/2025

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