55714-4828 NDC - BREAST CARE - FIBROCYSTIC (BUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUM)

Drug Information

  • Product NDC: 55714-4828
  • Proprietary Name: Breast Care - Fibrocystic
  • Non Proprietary Name: Bufo rana, Apis mel., Asterias rubens, Belladonna, Bryonia, Calc. carb., Chamomilla, Chimaphila umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias dioica, Lachesis, Merc. viv., Phellandrium aquaticum Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, Taraxacum
  • Active Ingredient(s): 15 [hp_X]/mL ANEMONE PULSATILLA; 15 [hp_X]/mL APIS MELLIFERA; 15 [hp_X]/mL ASTERIAS RUBENS; 15 [hp_X]/mL ATROPA BELLADONNA; 15 [hp_X]/mL BRYONIA ALBA ROOT; 15 [hp_X]/mL BUFO BUFO CUTANEOUS GLAND; 15 [hp_X]/mL CHAMAELIRIUM LUTEUM ROOT; 15 [hp_X]/mL CHIMAPHILA UMBELLATA; 15 [hp_X]/mL CINCHONA OFFICINALIS BARK; 15 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP; 15 [hp_X]/mL CROTON TIGLIUM SEED; 15 [hp_X]/mL ECHINACEA, UNSPECIFIED; 15 [hp_X]/mL GRAPHITE; 6 [hp_X]/mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; 15 [hp_X]/mL LACHESIS MUTA VENOM; 15 [hp_X]/mL MATRICARIA CHAMOMILLA; 15 [hp_X]/mL MERCURY; 15 [hp_X]/mL OENANTHE AQUATICA FRUIT; 15 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE; 15 [hp_X]/mL PHOSPHORUS; 15 [hp_X]/mL PHYTOLACCA AMERICANA ROOT; 6 [hp_X]/mL RUTA GRAVEOLENS FLOWERING TOP; 15 [hp_X]/mL SANGUINARIA CANADENSIS ROOT; 15 [hp_X]/mL SILICON DIOXIDE; 6 [hp_X]/mL TARAXACUM OFFICINALE
  • 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: Newton Laboratories, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:9/2/2018

Package Information

No. Package Code Package Description Billing Unit
155714-4828-130 mL in 1 BOTTLE, GLASS (55714-4828-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC55714-4828The 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 NAMEBreast Care - FibrocysticThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBufo rana, Apis mel., Asterias rubens, Belladonna, Bryonia, Calc. carb., Chamomilla, Chimaphila umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias dioica, Lachesis, Merc. viv., Phellandrium aquaticum Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, TaraxacumThe 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 DATE9/2/2018This 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 NAMENewton Laboratories, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEANEMONE PULSATILLA; APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CHAMAELIRIUM LUTEUM ROOT; CHIMAPHILA UMBELLATA; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; MATRICARIA CHAMOMILLA; MERCURY; OENANTHE AQUATICA FRUIT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; TARAXACUM OFFICINALEAn 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 STRENGTH15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 6 
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], 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: 11/21/2025

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