55714-2492 NDC - NERVOUSNESS - ANXIETY (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, AMBRA GRISEA, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, ASAFOETIDA, BRYONIA, CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, HYPERICUM PERFORATUM, IGNATIA AMARA, KALI PHOSPHORICUM, NUX VOMICA, SAMBUCUS NIGRA, STRYCHNINUM, THERIDION, VALERIANA OFFICINALIS.)

Drug Information

Product NDC: 55714-2492

Proprietary Name: Nervousness - Anxiety

Non Proprietary Name: Passiflora incarnata, Valeriana officinalis, Aconitum napellus, Ambra grisea, Anacardium orientale, Argentum nitricum, Asafoetida, Bryonia, Chamomilla, Cimicifuga racemosa, Coffea cruda, Cypripedium pubescens, Gelsemium sempervirens, Hyoscyamus niger, Hypericum perforatum, Ignatia amara, Kali phosphoricum, Nux vomica, Sambucus nigra, Strychninum, Theridion, Valeriana officinalis.

Active Ingredient(s):
  • 15 [hp_X]/g ACONITUM NAPELLUS;
  • 15 [hp_X]/g AMBERGRIS;
  • 15 [hp_X]/g ARABICA COFFEE BEAN;
  • 15 [hp_X]/g BLACK COHOSH;
  • 15 [hp_X]/g BRYONIA ALBA ROOT;
  • 15 [hp_X]/g CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT;
  • 15 [hp_X]/g DIBASIC POTASSIUM PHOSPHATE;
  • 15 [hp_X]/g FERULA ASSA-FOETIDA RESIN;
  • 15 [hp_X]/g GELSEMIUM SEMPERVIRENS ROOT;
  • 15 [hp_X]/g HYOSCYAMUS NIGER;
  • 15 [hp_X]/g HYPERICUM PERFORATUM;
  • 15 [hp_X]/g MATRICARIA CHAMOMILLA;
  • 6 [hp_X]/g PASSIFLORA INCARNATA FLOWERING TOP;
  • 15 [hp_X]/g SAMBUCUS NIGRA FLOWERING TOP;
  • 15 [hp_X]/g SEMECARPUS ANACARDIUM JUICE;
  • 15 [hp_X]/g SILVER NITRATE;
  • 15 [hp_X]/g STRYCHNINE;
  • 15 [hp_X]/g STRYCHNOS IGNATII SEED;
  • 15 [hp_X]/g STRYCHNOS NUX-VOMICA SEED;
  • 15 [hp_X]/g THERIDION CURASSAVICUM;
  • 15 [hp_X]/g VALERIAN


Administration Route(s): ORAL

Dosage Form(s): PELLET

Pharmacy Class(es):
  • Allergens [CS];
  • Allergens [CS];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [PE];
  • Dietary Proteins [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];
  • Non-Standardized Plant Allergenic Extract [EPC];
  • Plant Proteins [CS];
  • Plant Proteins [CS];
  • Seed Storage Proteins [CS];
  • Seed Storage Proteins [CS]

Labeler Information

Labeler Name: Newton Laboratories, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:1/1/2019

Package Information

No. Package Code Package Description Billing Unit
155714-2492-128 g in 1 BOTTLE, GLASS (55714-2492-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC55714-2492The 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 NAMENervousness - AnxietyThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEPassiflora incarnata, Valeriana officinalis, Aconitum napellus, Ambra grisea, Anacardium orientale, Argentum nitricum, Asafoetida, Bryonia, Chamomilla, Cimicifuga racemosa, Coffea cruda, Cypripedium pubescens, Gelsemium sempervirens, Hyoscyamus niger, Hypericum perforatum, Ignatia amara, Kali phosphoricum, Nux vomica, Sambucus nigra, Strychninum, Theridion, Valeriana officinalis.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 DATE1/1/2019This 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 NAMEACONITUM NAPELLUS; AMBERGRIS; ARABICA COFFEE BEAN; BLACK COHOSH; BRYONIA ALBA ROOT; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; DIBASIC POTASSIUM PHOSPHATE; FERULA ASSA-FOETIDA RESIN; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; MATRICARIA CHAMOMILLA; PASSIFLORA INCARNATA FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; STRYCHNINE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; VALERIANAn 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 
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 
PHARM CLASSESAllergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [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], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS] 

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This page was last updated on: 2/1/2023