Estropro Spray
NDC 43853-0038

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 43853-0038?
  4. Estropro Homeopathic Organotherapy Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Estropro (agnus castus, angelica sin, apis mel, cimicifuga rac, estradiol, estriol, folliculinum, galium, glycyrrhiza, oophorinum, progesterone, sepia) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Problen. This medication is typically used as a allergens [cs]. It is supplied as a spray for oral administration. This product entry covers the primary NDC 43853-0038 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
43853-0038
Proprietary Name:
Estropro Homeopathic Organotherapy
Non-Proprietary Name: [1]
Agnus Castus, Angelica Sin, Apis Mel, Cimicifuga Rac, Estradiol, Estriol, Folliculinum, Galium, Glycyrrhiza, Oophorinum, Progesterone, Sepia
Substance Name: [2]
Angelica Sinensis Root; Apis Mellifera; Black Cohosh; Chaste Tree; Estradiol; Estriol; Estrone; Galium Aparine; Glycyrrhiza Glabra; Progesterone; Sepia Officinalis Juice; Sus Scrofa Ovary
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Problen
Labeler Code:
43853
Product Label ID:
4696d365-7667-c25e-e063-6294a90a8dea
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
12-22-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 43853-0038?

The NDC code 43853-0038 is assigned by the FDA to the product Estropro Homeopathic Organotherapy. It is commonly known by its generic name, agnus castus, angelica sin, apis mel, cimicifuga rac, estradiol, estriol, folliculinum, galium, glycyrrhiza, oophorinum, progesterone, sepia. This pharmaceutical product is labeled by Problen and is currently categorized as listed product. The medication is a spray administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 43853-0038-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Uses: Temporarily supports the body to rebalance estrogen and progesterone output. Symptoms may include: mood swings, hot flashes, irritability, lack of energy.* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

What are Active Ingredients of this product?

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.
  • ANGELICA SINENSIS ROOT 3 [hp_X]/mL
  • APIS MELLIFERA 6 [hp_X]/mL
  • BLACK COHOSH 3 [hp_X]/mL
  • CHASTE TREE 3 [hp_X]/mL - A genus of trees in the Lamiaceae family containing assorted flavonoids with possible analgesic and antineoplastic properties. The fruit of these trees is used in herbal preparations.
  • ESTRADIOL 9 [hp_C]/mL - The 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids.
  • ESTRIOL 9 [hp_C]/mL - A hydroxylated metabolite of ESTRADIOL or ESTRONE that has a hydroxyl group at C3, 16-alpha, and 17-beta position. Estriol is a major urinary estrogen. During PREGNANCY, a large amount of estriol is produced by the PLACENTA. Isomers with inversion of the hydroxyl group or groups are called epiestriol.
  • ESTRONE 9 [hp_C]/mL - An aromatized C18 steroid with a 3-hydroxyl group and a 17-ketone, a major mammalian estrogen. It is converted from ANDROSTENEDIONE directly, or from TESTOSTERONE via ESTRADIOL. In humans, it is produced primarily by the cyclic ovaries, PLACENTA, and the ADIPOSE TISSUE of men and postmenopausal women.
  • GALIUM APARINE 3 [hp_X]/mL - A genus of herbaceous annual and perennial plants in the family RUBIACEAE.
  • GLYCYRRHIZA GLABRA 3 [hp_X]/mL - A genus of leguminous herbs or shrubs whose roots yield GLYCYRRHETINIC ACID and its derivative, CARBENOXOLONE.
  • PROGESTERONE 6 [hp_X]/mL - The major progestational steroid that is secreted primarily by the CORPUS LUTEUM and the PLACENTA. Progesterone acts on the UTERUS, the MAMMARY GLANDS and the BRAIN. It is required in EMBRYO IMPLANTATION; PREGNANCY maintenance, and the development of mammary tissue for MILK production. Progesterone, converted from PREGNENOLONE, also serves as an intermediate in the biosynthesis of GONADAL STEROID HORMONES and adrenal CORTICOSTEROIDS.
  • SEPIA OFFICINALIS JUICE 30 [hp_C]/mL
  • SUS SCROFA OVARY 30 [hp_C]/mL

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? 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.
What kind of product is this? 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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".