43853-0017 NDC - ESTROGEN AND PROGESTERONE (AGNUS CASTUS, ANGELICA SINENSIS, APIS MELLIFICA, ARNICA MONTANA, CIMICIFUGA RACEMOSA, ESTRADIOL, ESTRIOL, FOLLICULINUM, GALIUM APARINE, GLYCYRRHIZA GLABRA, KOREAN GINSENG, OOPHORINUM (SUIS), PROGESTERONE, SEPIA, THUJA OCCIDENTALIS, VISCUM ALBUM)

Drug Information

  • Product NDC: 43853-0017
  • Proprietary Name: Estrogen and Progesterone
  • Non Proprietary Name: Agnus Castus, Angelica Sinensis, Apis Mellifica, Arnica Montana, Cimicifuga Racemosa, Estradiol, Estriol, Folliculinum, Galium Aparine, Glycyrrhiza Glabra, Korean Ginseng, Oophorinum (Suis), Progesterone, Sepia, Thuja Occidentalis, Viscum Album
  • Active Ingredient(s): 3 [hp_X]/mL ANGELICA SINENSIS ROOT; 6 [hp_X]/mL APIS MELLIFERA; 6 [hp_X]/mL ARNICA MONTANA; 3 [hp_X]/mL ASIAN GINSENG; 3 [hp_X]/mL BLACK COHOSH; 3 [hp_X]/mL CHASTE TREE; 9 [hp_C]/mL ESTRADIOL; 9 [hp_C]/mL ESTRIOL; 9 [hp_C]/mL ESTRONE; 3 [hp_X]/mL GALIUM APARINE; 3 [hp_X]/mL GLYCYRRHIZA GLABRA; 6 [hp_X]/mL PROGESTERONE; 30 [hp_C]/mL SEPIA OFFICINALIS JUICE; 30 [hp_C]/mL SUS SCROFA OVARY; 6 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG; 3 [hp_X]/mL VISCUM ALBUM FRUITING TOP
  • Administration Route(s): ORAL
  • Dosage Form(s): SPRAY
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Bee Venoms [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Estradiol Congeners [CS]; Estrogen Receptor Agonists [MoA]; Estrogen [EPC]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Progesterone [CS]; Progesterone [EPC]; Standardized Insect Venom Allergenic Extract [EPC]

Labeler Information

Field Name Field Value
Labeler Name: ProBLEN
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:1/12/2017

Package Information

No. Package Code Package Description Billing Unit
143853-0017-21 BOTTLE, SPRAY in 1 CARTON (43853-0017-2) / 30 mL in 1 BOTTLE, SPRAY (43853-0017-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC43853-0017The 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 NAMEEstrogen and ProgesteroneThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAgnus Castus, Angelica Sinensis, Apis Mellifica, Arnica Montana, Cimicifuga Racemosa, Estradiol, Estriol, Folliculinum, Galium Aparine, Glycyrrhiza Glabra, Korean Ginseng, Oophorinum (Suis), Progesterone, Sepia, Thuja Occidentalis, Viscum AlbumThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESPRAYThe 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 DATE1/12/2017This 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 NAMEProBLENName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEANGELICA SINENSIS ROOT; APIS MELLIFERA; ARNICA MONTANA; ASIAN GINSENG; BLACK COHOSH; CHASTE TREE; ESTRADIOL; ESTRIOL; ESTRONE; GALIUM APARINE; GLYCYRRHIZA GLABRA; PROGESTERONE; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOPAn 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; 6; 6; 3; 3; 3; 9; 9; 9; 3; 3; 6; 30; 30; 6; 3 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Progesterone [CS], Progesterone [EPC], Standardized Insect Venom Allergenic Extract [EPC] 

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This page was last updated on: 11/21/2025

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