Hormone Balance Liquid
NDC 62185-0050

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 62185-0050?
  4. Hormone Balance Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Hormone Balance (acetaldehyde, dopamine hydrochloride, dhea (dehydroepiandrosterone), 7-oxo-dehydroepiandrosterone-3b-acetate, folliculinum, oophorinum (suis), cholesterinum, progesterone, testosterone, cortisone aceticum, aldosterone, androsterone, follicle stimulating hormone) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Dr. Donna Restivo Dc. This medication is typically used as a androgen receptor agonists [moa]. It is supplied as a liquid for oral administration. This product entry covers the primary NDC 62185-0050 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
62185-0050
Proprietary Name:
Hormone Balance
Non-Proprietary Name: [1]
Acetaldehyde, Dopamine Hydrochloride, Dhea (dehydroepiandrosterone), 7-oxo-dehydroepiandrosterone-3b-acetate, Folliculinum, Oophorinum (suis), Cholesterinum, Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone
Substance Name: [2]
7-oxodehydroepiandrosterone 3-acetate; Acetaldehyde; Aldosterone; Androsterone; Cholesterol; Cortisone Acetate; Dopamine Hydrochloride; Estrone; Follitropin; Progesterone; Sus Scrofa Ovary; Testosterone
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Dr. Donna Restivo Dc
Labeler Code:
62185
Product Label ID:
421707d6-31c1-4d57-b017-796fc872efe4
DEA Schedule: [7]
Schedule III (CIII) Substances
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
09-03-2019
End Marketing Date: [10]
03-01-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 62185-0050?

The NDC code 62185-0050 is assigned by the FDA to the product Hormone Balance. It is commonly known by its generic name, acetaldehyde, dopamine hydrochloride, dhea (dehydroepiandrosterone), 7-oxo-dehydroepiandrosterone-3b-acetate, folliculinum, oophorinum (suis), cholesterinum, progesterone, testosterone, cortisone aceticum, aldosterone, androsterone, follicle stimulating hormone. This pharmaceutical product is labeled by Dr. Donna Restivo Dc and is currently categorized as listed product. The medication is a liquid administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 62185-0050-1. 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?

Temporary relief of symptoms related to hormone imbalances or insufficiencies in men and women, including low energy, inability to handle stress, trouble focusing, changes in mood, infertility, irregular menstrual cycles (females) and lack of libido.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration. Temporary relief of symptoms related to hormone imbalances or insufficiencies in men and women, including low energy, inability to handle stress, trouble focusing, changes in mood, infertility, irregular menstrual cycles (females) and lack of libido.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

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.
  • 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE 6 [hp_X]/mL
  • ACETALDEHYDE 6 [hp_X]/mL - A colorless, flammable liquid used in the manufacture of acetic acid, perfumes, and flavors. It is also an intermediate in the metabolism of alcohol. It has a general narcotic action and also causes irritation of mucous membranes. Large doses may cause death from respiratory paralysis.
  • ALDOSTERONE 12 [hp_C]/mL - A hormone secreted by the ADRENAL CORTEX that regulates electrolyte and water balance by increasing the renal retention of sodium and the excretion of potassium.
  • ANDROSTERONE 12 [hp_C]/mL - A metabolite of TESTOSTERONE or ANDROSTENEDIONE with a 3-alpha-hydroxyl group and without the double bond. The 3-beta hydroxyl isomer is epiandrosterone.
  • CHOLESTEROL 8 [hp_X]/mL - The principal sterol of all higher animals, distributed in body tissues, especially the brain and spinal cord, and in animal fats and oils.
  • CORTISONE ACETATE 12 [hp_X]/mL - A naturally occurring glucocorticoid that has been used in replacement therapy for ADRENAL INSUFFICIENCY and as an anti-inflammatory agent. Cortisone itself is inactive; it is converted in the liver to the active metabolite HYDROCORTISONE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p726)
  • DOPAMINE HYDROCHLORIDE 6 [hp_X]/mL - One of the catecholamine NEUROTRANSMITTERS in the brain. It is derived from TYROSINE and is the precursor to NOREPINEPHRINE and EPINEPHRINE. Dopamine is a major transmitter in the extrapyramidal system of the brain, and important in regulating movement. A family of receptors (RECEPTORS, DOPAMINE) mediate its action.
  • ESTRONE 8 [hp_X]/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.
  • FOLLITROPIN 12 [hp_C]/mL - A major gonadotropin secreted by the adenohypophysis (PITUITARY GLAND, ANTERIOR). Follicle-stimulating hormone stimulates GAMETOGENESIS and the supporting cells such as the ovarian GRANULOSA CELLS, the testicular SERTOLI CELLS, and LEYDIG CELLS. FSH consists of two noncovalently linked subunits, alpha and beta. Within a species, the alpha subunit is common in the three pituitary glycoprotein hormones (TSH, LH, and FSH), but the beta subunit is unique and confers its biological specificity.
  • PROGESTERONE 8 [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.
  • SUS SCROFA OVARY 8 [hp_X]/mL
  • TESTOSTERONE 8 [hp_X]/mL - A potent androgenic steroid and major product secreted by the LEYDIG CELLS of the TESTIS. Its production is stimulated by LUTEINIZING HORMONE from the PITUITARY GLAND. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to DIHYDROTESTOSTERONE or ESTRADIOL.

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:

* Please review the full disclaimer at the bottom of this page.

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 DEA Schedule? This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".