62106-0623 NDC - HFE (APIS MELLIFICA, BELLADONNA, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, HELONIAS DIOICA, MAGNESIA PHOSPHORICA, ORYCTOLAGUS CUNICULUS (RABBIT) ADRENAL GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) OVARY, ORYCTOLAGUS CUNICULUS (RABBIT) UTERUS, VIBURNUM OPULUS)

Drug Information

  • Product NDC: 62106-0623
  • Proprietary Name: HFE
  • Non Proprietary Name: Apis mellifica, Belladonna, Caulophyllum thalictroides, Cimicifuga racemosa, Dioscorea villosa, Gelsemium sempervirens, Helonias dioica, Magnesia phosphorica, Oryctolagus cuniculus (Rabbit) Adrenal Gland, Oryctolagus cuniculus (Rabbit) Ovary, Oryctolagus cuniculus (Rabbit) Uterus, Viburnum opulus
  • Active Ingredient(s): 5 [hp_X]/30mL APIS MELLIFERA; 4 [hp_X]/30mL ATROPA BELLADONNA; 6 [hp_X]/30mL BLACK COHOSH; 4 [hp_X]/30mL CAULOPHYLLUM THALICTROIDES ROOT; 4 [hp_X]/30mL CHAMAELIRIUM LUTEUM ROOT; 4 [hp_X]/30mL DIOSCOREA VILLOSA ROOT; 8 [hp_X]/30mL GELSEMIUM SEMPERVIRENS ROOT; 10 [hp_X]/30mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; 10 [hp_X]/30mL ORYCTOLAGUS CUNICULUS ADRENAL GLAND; 10 [hp_X]/30mL ORYCTOLAGUS CUNICULUS OVARY; 10 [hp_X]/30mL ORYCTOLAGUS CUNICULUS UTERUS; 2 [hp_X]/30mL VIBURNUM OPULUS BARK
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; Bee Venoms [CS]; Calculi Dissolution Agent [EPC]; Cell-mediated Immunity [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: Seroyal USA
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:12/18/2018

Package Information

No. Package Code Package Description Billing Unit
162106-0623-030 mL in 1 BOTTLE, GLASS (62106-0623-0)

NDC Record

Field Name Field Value Definition
PRODUCT NDC62106-0623The 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 NAMEHFEThe 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, Belladonna, Caulophyllum thalictroides, Cimicifuga racemosa, Dioscorea villosa, Gelsemium sempervirens, Helonias dioica, Magnesia phosphorica, Oryctolagus cuniculus (Rabbit) Adrenal Gland, Oryctolagus cuniculus (Rabbit) Ovary, Oryctolagus cuniculus (Rabbit) Uterus, Viburnum opulusThe 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 DATE12/18/2018This 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 NAMESeroyal USAName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAPIS MELLIFERA; ATROPA BELLADONNA; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; DIOSCOREA VILLOSA ROOT; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ORYCTOLAGUS CUNICULUS ADRENAL GLAND; ORYCTOLAGUS CUNICULUS OVARY; ORYCTOLAGUS CUNICULUS UTERUS; VIBURNUM OPULUS BARKAn 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 STRENGTH5; 4; 6; 4; 4; 4; 8; 10; 10; 10; 10; 2 
ACTIVE INGRED UNIT[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 
PHARM CLASSESAllergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [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: 11/21/2025

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