44911-0716 NDC - GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, AURUM MURIATICUM NATRONATUM, BORAX, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, LILIUM TIGRINUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS)

Drug Information

  • Product NDC: 44911-0716
  • Proprietary Name: Gynestat
  • Non Proprietary Name: Cimicifuga Racemosa, Eucalyptus Globulus, Argentum Nitricum, Aurum Muriaticum Natronatum, Borax, Calcarea Carbonica, Kali Bichromicum, Kreosotum, Lilium Tigrinum, Mercurius Solubilis, Pulsatilla (Pratensis), Sepia, Staphysagria, Thuja Occidentalis
  • Active Ingredient(s): 3 [hp_X]/mL BLACK COHOSH; 12 [hp_X]/mL DELPHINIUM STAPHISAGRIA SEED; 3 [hp_X]/mL EUCALYPTUS GLOBULUS LEAF; 12 [hp_X]/mL LILIUM LANCIFOLIUM WHOLE FLOWERING; 12 [hp_X]/mL MERCURIUS SOLUBILIS; 12 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE; 12 [hp_X]/mL POTASSIUM DICHROMATE; 12 [hp_X]/mL PULSATILLA PRATENSIS WHOLE; 12 [hp_X]/mL SEPIA OFFICINALIS JUICE; 12 [hp_X]/mL SILVER NITRATE; 12 [hp_X]/mL SODIUM BORATE; 12 [hp_X]/mL SODIUM TETRACHLOROAURATE; 12 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG; 12 [hp_X]/mL WOOD CREOSOTE
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID

Labeler Information

Field Name Field Value
Labeler Name: Energique, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:8/2/2024

Package Information

No. Package Code Package Description Billing Unit
144911-0716-130 mL in 1 BOTTLE, DROPPER (44911-0716-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC44911-0716The 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 NAMEGynestatThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECimicifuga Racemosa, Eucalyptus Globulus, Argentum Nitricum, Aurum Muriaticum Natronatum, Borax, Calcarea Carbonica, Kali Bichromicum, Kreosotum, Lilium Tigrinum, Mercurius Solubilis, Pulsatilla (Pratensis), Sepia, Staphysagria, Thuja OccidentalisThe 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 DATE8/2/2024This 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 NAMEEnergique, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBLACK COHOSH; DELPHINIUM STAPHISAGRIA SEED; EUCALYPTUS GLOBULUS LEAF; LILIUM LANCIFOLIUM WHOLE FLOWERING; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM BORATE; SODIUM TETRACHLOROAURATE; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTEAn 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; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 
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 

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

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