55714-2483 NDC - MORNING SICKNESS-NAUSEA (CHAMOMILLA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, BISMUTHUM METALLICUM, BRYONIA, CIMICIFUGA RACEMOSA, GOSSYPIUM HERBACEUM, IPECACUANHA, KREOSOTUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PULSATILLA, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, ZINGIBER OFFICINALE.)

Drug Information

Product NDC: 55714-2483
Proprietary Name: Morning Sickness-Nausea
Non Proprietary Name: Chamomilla, Hydrastis canadensis, Iris versicolor, Bismuthum metallicum, Bryonia, Cimicifuga racemosa, Gossypium herbaceum, Ipecacuanha, Kreosotum, Lycopodium clavatum, Magnesia carbonica, Nux vomica, Pulsatilla, Sepia, Symphoricarpus racemosus, Tabacum, Zingiber officinale.
Active Ingredient(s): 15 [hp_X]/mL ANEMONE PULSATILLA; 15 [hp_X]/mL BISMUTH; 15 [hp_X]/mL BLACK COHOSH; 15 [hp_X]/mL BRYONIA ALBA ROOT; 15 [hp_X]/mL GINGER; 6 [hp_X]/mL GOLDENSEAL; 15 [hp_X]/mL GOSSYPIUM HERBACEUM ROOT BARK; 15 [hp_X]/mL IPECAC; 6 [hp_X]/mL IRIS VERSICOLOR ROOT; 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE; 15 [hp_X]/mL MAGNESIUM CARBONATE; 6 [hp_X]/mL MATRICARIA CHAMOMILLA; 15 [hp_X]/mL SEPIA OFFICINALIS JUICE; 15 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED; 15 [hp_X]/mL SYMPHORICARPOS ALBUS FRUIT; 15 [hp_X]/mL TOBACCO LEAF; 15 [hp_X]/mL WOOD CREOSOTE
Administration Route(s): ORAL
Dosage Form(s): LIQUID
Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Food Additives [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [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:	1/1/2019

Package Information

No.	Package Code	Package Description	Billing Unit
1	55714-2483-1	30 mL in 1 BOTTLE, GLASS (55714-2483-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	55714-2483	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	Morning Sickness-Nausea	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	Chamomilla, Hydrastis canadensis, Iris versicolor, Bismuthum metallicum, Bryonia, Cimicifuga racemosa, Gossypium herbaceum, Ipecacuanha, Kreosotum, Lycopodium clavatum, Magnesia carbonica, Nux vomica, Pulsatilla, Sepia, Symphoricarpus racemosus, Tabacum, Zingiber officinale.	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	1/1/2019	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	ANEMONE PULSATILLA; BISMUTH; BLACK COHOSH; BRYONIA ALBA ROOT; GINGER; GOLDENSEAL; GOSSYPIUM HERBACEUM ROOT BARK; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA CHAMOMILLA; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SYMPHORICARPOS ALBUS FRUIT; TOBACCO LEAF; WOOD CREOSOTE	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; 15; 15; 15; 6; 15; 15; 6; 15; 15; 6; 15; 15; 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; [hp_X]/mL; [hp_X]/mL
PHARM CLASSES	Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]

Drug Information

Labeler Information

Package Information

NDC Record

Download Record