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  4. NDC Product Code: 44911-0635 Body Balance

NDC 44911-0635 Body Balance

Avena Sativa,Chlorophytum Borivilianum,Nuphar Luteum,Hypothalamus Suis,Orchitinum - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 44911-0635?
  4. Body Balance Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
44911-0635
Proprietary Name:
Body Balance
Non-Proprietary Name: [1]
Avena Sativa, Chlorophytum Borivilianum, Nuphar Luteum, Hypothalamus Suis, Orchitinum (suis), Damiana, Selenium Metallicum, Staphysagria, Thuja Occidentalis
Substance Name: [2]
Avena Sativa Flowering Top; Bos Taurus Hypothalamus; Chlorophytum Borivilianum Whole; Delphinium Staphisagria Seed; Nuphar Lutea Root; Punica Granatum Root Bark; Selenium; Sus Scrofa Testicle; Thuja Occidentalis Leafy Twig; Turnera Diffusa Leafy Twig
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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 Name: [5]
    Energique, Inc.
    Labeler Code:
    44911
    Product Label ID:
    d8e70220-b3ef-4595-a8c3-a77a6bd373e4
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    03-16-2021
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 44911-0635-1

    Package Description: 30 mL in 1 BOTTLE, SPRAY

    Product Details

    What is NDC 44911-0635?

    The NDC code 44911-0635 is assigned by the FDA to the product Body Balance which is a human over the counter drug product labeled by Energique, Inc.. The generic name of Body Balance is avena sativa, chlorophytum borivilianum, nuphar luteum, hypothalamus suis, orchitinum (suis), damiana, selenium metallicum, staphysagria, thuja occidentalis. The product's dosage form is spray and is administered via oral form. The product is distributed in a single package with assigned NDC code 44911-0635-1 30 ml in 1 bottle, spray . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Body Balance?

    Temporarily relieves symptoms of low sexual energy and dysfunction which may be due to prostatitis, endometritis, endometriosis, low or poor sperm production, fatigue and decreased responsiveness.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Temporarily relieves symptoms of low sexual energy and dysfunction which may be due to prostatitis, endometritis, endometriosis, low or poor sperm production, fatigue and decreased responsiveness.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

    What are Body Balance Active Ingredients?

    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.

    Which are Body Balance UNII Codes?

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

    • AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)
    • AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (Active Moiety)
    • CHLOROPHYTUM BORIVILIANUM WHOLE (UNII: B0MD133CE7)
    • CHLOROPHYTUM BORIVILIANUM WHOLE (UNII: B0MD133CE7) (Active Moiety)
    • PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
    • PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) (Active Moiety)
    • NUPHAR LUTEA ROOT (UNII: 714LIU3V6D)
    • NUPHAR LUTEA ROOT (UNII: 714LIU3V6D) (Active Moiety)
    • BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7)
    • BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (Active Moiety)
    • SUS SCROFA TESTICLE (UNII: KM02613O28)
    • SUS SCROFA TESTICLE (UNII: KM02613O28) (Active Moiety)
    • TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ)
    • TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (Active Moiety)
    • SELENIUM (UNII: H6241UJ22B)
    • SELENIUM (UNII: H6241UJ22B) (Active Moiety)
    • DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV)
    • DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (Active Moiety)
    • THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397)
    • THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (Active Moiety)

    Which are Body Balance Inactive Ingredients 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 disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".