43857-0204 NDC - OVAPLEX (ANGELICA ARCHANGELICA, CAULOPHYLLUM THALICTROIDES, DIOSCOREA VILLOSA, HYPOPHYSIS SUIS, OOPHORINUM (SUIS) THYROIDINUM (SUIS), UTERUS SUIS, ZINCUM GLUCONICUM, APIS MELLIFICA, BELLADONNA, CIMICIFUGA RACEMOSA, MAGNESIA PHOSPHORICA, SEPIA)

Drug Information

  • Product NDC: 43857-0204
  • Proprietary Name: Ovaplex
  • Non Proprietary Name: Angelica Archangelica, Caulophyllum Thalictroides, Dioscorea Villosa, Hypophysis Suis, Oophorinum (Suis) Thyroidinum (Suis), Uterus Suis, Zincum Gluconicum, Apis Mellifica, Belladonna, Cimicifuga Racemosa, Magnesia Phosphorica, Sepia
  • Active Ingredient(s): 3 [hp_X]/mL ANGELICA ARCHANGELICA ROOT; 12 [hp_X]/mL APIS MELLIFERA; 12 [hp_X]/mL ATROPA BELLADONNA; 12 [hp_X]/mL BLACK COHOSH; 3 [hp_X]/mL CAULOPHYLLUM THALICTROIDES ROOT; 3 [hp_X]/mL DIOSCOREA VILLOSA TUBER; 12 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; 12 [hp_X]/mL SEPIA OFFICINALIS JUICE; 6 [hp_X]/mL SUS SCROFA OVARY; 6 [hp_X]/mL SUS SCROFA PITUITARY GLAND; 6 [hp_X]/mL SUS SCROFA UTERUS; 6 [hp_X]/mL THYROID; 6 [hp_X]/mL ZINC GLUCONATE
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; Bee Venoms [CS]; Calculi Dissolution Agent [EPC]; Cell-mediated Immunity [PE]; Copper Absorption Inhibitor [EPC]; Decreased Copper Ion Absorption [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Standardized Insect Venom Allergenic Extract [EPC]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Labeler Information

Field Name Field Value
Labeler Name: BioActive Nutritional, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:8/21/2013

Package Information

No. Package Code Package Description Billing Unit
143857-0204-130 mL in 1 BOTTLE, DROPPER (43857-0204-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC43857-0204The 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 NAMEOvaplexThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAngelica Archangelica, Caulophyllum Thalictroides, Dioscorea Villosa, Hypophysis Suis, Oophorinum (Suis) Thyroidinum (Suis), Uterus Suis, Zincum Gluconicum, Apis Mellifica, Belladonna, Cimicifuga Racemosa, Magnesia Phosphorica, SepiaThe 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 DATE8/21/2013This 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 NAMEBioActive Nutritional, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEANGELICA ARCHANGELICA ROOT; APIS MELLIFERA; ATROPA BELLADONNA; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; DIOSCOREA VILLOSA TUBER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; SUS SCROFA UTERUS; THYROID; ZINC GLUCONATEAn 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 STRENGTH3; 12; 12; 12; 3; 3; 12; 12; 6; 6; 6; 6; 6 
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 
PHARM CLASSESAllergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 

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This page was last updated on: 6/6/2025

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