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

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

Package Information

No.	Package Code	Package Description	Billing Unit
1	55714-4786-1	30 mL in 1 BOTTLE, GLASS (55714-4786-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	55714-4786	The 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 NAME	HUMAN OTC DRUG	Indicates 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 NAME	Mega Menses	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
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.	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	LIQUID	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	9/2/2019	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	Product 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 NAME	Newton Laboratories, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACHILLEA 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 ROOT	An 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 STRENGTH	15; 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 CLASSES	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]

Drug Information

Labeler Information

Package Information

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