55714-4786 NDC - MEGA MENSES (APIS MELLIFICA, HAMAMELIS VIRGINIANA, HYDRASTIS CANADENSIS, ALETRIS FARINOSA, APOCYNUM CANNABINUM, CINCHONA OFFICINALIS, CINNAMOMUM, CONIUM MACULATUM, HELONIAS DIOICA, LILIUM TIGRINUM, MILLEFOLIUM, PHOSPHORUS, SECALE CORNUTUM, THLASPI BURSA-PASTORIS, TRILLIUM PENDULUM.)

Drug Information

Product NDC: 55714-4786

Proprietary Name: Mega Menses

Non Proprietary Name: Apis mellifica, Hamamelis virginiana, Hydrastis canadensis, Aletris farinosa, Apocynum cannabinum, Cinchona officinalis, Cinnamomum, Conium maculatum, Helonias dioica, Lilium tigrinum, Millefolium, Phosphorus, Secale cornutum, Thlaspi bursa-pastoris, Trillium pendulum.

Active Ingredient(s):
  • 15 [hp_X]/mL ACHILLEA MILLEFOLIUM;
  • 15 [hp_X]/mL ALETRIS FARINOSA ROOT;
  • 6 [hp_X]/mL APIS MELLIFERA;
  • 15 [hp_X]/mL APOCYNUM CANNABINUM ROOT;
  • 15 [hp_X]/mL CAPSELLA BURSA-PASTORIS;
  • 15 [hp_X]/mL CHAMAELIRIUM LUTEUM ROOT;
  • 15 [hp_X]/mL CINCHONA OFFICINALIS BARK;
  • 15 [hp_X]/mL CINNAMON;
  • 15 [hp_X]/mL CLAVICEPS PURPUREA SCLEROTIUM;
  • 15 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP;
  • 6 [hp_X]/mL GOLDENSEAL;
  • 6 [hp_X]/mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK;
  • 15 [hp_X]/mL LILIUM LANCIFOLIUM WHOLE FLOWERING;
  • 15 [hp_X]/mL PHOSPHORUS;
  • 15 [hp_X]/mL TRILLIUM ERECTUM ROOT


Administration Route(s): ORAL

Dosage Form(s): LIQUID

Pharmacy Class(es):
  • Allergens [CS];
  • Allergens [CS];
  • Bee Venoms [CS];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [PE];
  • Dietary Proteins [CS];
  • Food Additives [CS];
  • Increased Histamine Release [PE];
  • Increased Histamine Release [PE];
  • Increased IgG Production [PE];
  • Non-Standardized Food Allergenic Extract [EPC];
  • Standardized Insect Venom Allergenic Extract [EPC]

Labeler Information

Labeler Name: Newton Laboratories, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:9/2/2019

Package Information

No. Package Code Package Description Billing Unit
155714-4786-130 mL in 1 BOTTLE, GLASS (55714-4786-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC55714-4786The 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 NAMEMega MensesThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEApis mellifica, Hamamelis virginiana, Hydrastis canadensis, Aletris farinosa, Apocynum cannabinum, Cinchona officinalis, Cinnamomum, Conium maculatum, Helonias dioica, Lilium tigrinum, Millefolium, Phosphorus, Secale cornutum, Thlaspi bursa-pastoris, Trillium pendulum.The 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 DATE9/2/2019This 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 NAMEACHILLEA MILLEFOLIUM; ALETRIS FARINOSA ROOT; APIS MELLIFERA; APOCYNUM CANNABINUM ROOT; CAPSELLA BURSA-PASTORIS; CHAMAELIRIUM LUTEUM ROOT; CINCHONA OFFICINALIS BARK; CINNAMON; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LILIUM LANCIFOLIUM WHOLE FLOWERING; PHOSPHORUS; TRILLIUM ERECTUM ROOTAn 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; 6; 15; 15; 15; 15; 15; 15; 15; 6; 6; 15; 15; 15 
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 
PHARM CLASSESAllergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC] 

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