55714-2594 NDC - PARA-SI (JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER)

Drug Information

  • Product NDC: 55714-2594
  • Proprietary Name: Para-Si
  • Non Proprietary Name: Juglans reg, Abrotanum, Aesculus hipp, Allium sat, Arsenicum alb, Artemisia, Baptisia, Cina, Cuprum met, Filix mas, Granatum, Ipecac, Lacheis, Lycopodium, Merc viv, Naphthalinum, Nat mur, Nux vom, Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth, Terebinthina, Teucrium mar, Thymolum, Zingiber
  • Active Ingredient(s): 15 [hp_X]/g ANEMONE PULSATILLA; 15 [hp_X]/g ARSENIC TRIOXIDE; 15 [hp_X]/g ARTEMISIA ABROTANUM FLOWERING TOP; 15 [hp_X]/g ARTEMISIA CINA PRE-FLOWERING TOP; 15 [hp_X]/g ARTEMISIA VULGARIS ROOT; 15 [hp_X]/g BAPTISIA TINCTORIA ROOT; 15 [hp_X]/g COPPER; 15 [hp_X]/g DRYOPTERIS FILIX-MAS ROOT; 15 [hp_X]/g GARLIC; 15 [hp_X]/g GINGER; 15 [hp_X]/g HORSE CHESTNUT; 15 [hp_X]/g IPECAC; 6 [hp_X]/g JUGLANS REGIA LEAF; 15 [hp_X]/g KRAMERIA LAPPACEA ROOT; 15 [hp_X]/g LACHESIS MUTA VENOM; 15 [hp_X]/g LYCOPODIUM CLAVATUM SPORE; 15 [hp_X]/g MERCURY; 15 [hp_X]/g NAPHTHALENE; 15 [hp_X]/g PUNICA GRANATUM ROOT BARK; 15 [hp_X]/g RUTA GRAVEOLENS FLOWERING TOP; 15 [hp_X]/g SANTONIN; 15 [hp_X]/g SCHOENOCAULON OFFICINALE SEED; 15 [hp_X]/g SILICON DIOXIDE; 15 [hp_X]/g SODIUM CHLORIDE; 15 [hp_X]/g SPIGELIA ANTHELMIA; 15 [hp_X]/g STRYCHNOS NUX-VOMICA SEED; 15 [hp_X]/g TEUCRIUM MARUM; 15 [hp_X]/g THYMOL; 15 [hp_X]/g TURPENTINE OIL
  • Administration Route(s): ORAL
  • Dosage Form(s): PELLET
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Copper [CS]; Copper-containing Intrauterine Device [EPC]; Decreased Embryonic Implantation [PE]; Decreased Sperm Motility [PE]; Dietary Proteins [CS]; Dietary Proteins [CS]; Food Additives [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased Large Intestinal Motility [PE]; Inhibit Ovum Fertilization [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Plant Proteins [CS]; Plant Proteins [CS]; Plant Proteins [CS]; Seed Storage Proteins [CS]

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:11/26/2024

Package Information

No. Package Code Package Description Billing Unit
155714-2594-128 g in 1 BOTTLE, GLASS (55714-2594-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC55714-2594The 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 NAMEPara-SiThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEJuglans reg, Abrotanum, Aesculus hipp, Allium sat, Arsenicum alb, Artemisia, Baptisia, Cina, Cuprum met, Filix mas, Granatum, Ipecac, Lacheis, Lycopodium, Merc viv, Naphthalinum, Nat mur, Nux vom, Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth, Terebinthina, Teucrium mar, Thymolum, ZingiberThe 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 DATE11/26/2024This 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 NAMEANEMONE PULSATILLA; ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA CINA PRE-FLOWERING TOP; ARTEMISIA VULGARIS ROOT; BAPTISIA TINCTORIA ROOT; COPPER; DRYOPTERIS FILIX-MAS ROOT; GARLIC; GINGER; HORSE CHESTNUT; IPECAC; JUGLANS REGIA LEAF; KRAMERIA LAPPACEA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; NAPHTHALENE; PUNICA GRANATUM ROOT BARK; RUTA GRAVEOLENS FLOWERING TOP; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM; THYMOL; TURPENTINE OILAn 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; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 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; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 
PHARM CLASSESAllergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS] 

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This page was last updated on: 12/19/2025

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