NDC 43742-0099 Hydration Complex

Beta Vulgaris, Boldo, Carduus Benedictus, Chelidonium Majus, Coffea Tosta, Equisetum Arvense, Petroselinum Sativum, Taraxacum Officinale, Hypericum Perforatum, Ginkgo Biloba, Kali Muriaticum, Kali Phosphoricum, Kali Sulphuricum, Germanium Sesquioxide, Silicea, Calcarea Fluorica, Calcarea Phosphorica

NDC Product Code 43742-0099

NDC Code: 43742-0099

Proprietary Name: Hydration Complex What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Beta Vulgaris, Boldo, Carduus Benedictus, Chelidonium Majus, Coffea Tosta, Equisetum Arvense, Petroselinum Sativum, Taraxacum Officinale, Hypericum Perforatum, Ginkgo Biloba, Kali Muriaticum, Kali Phosphoricum, Kali Sulphuricum, Germanium Sesquioxide, Silicea, Calcarea Fluorica, Calcarea Phosphorica 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.

NDC Code Structure

  • 43742 - Deseret Biologicals, Inc.
    • 43742-0099 - Hydration Complex

NDC 43742-0099-1

Package Description: 60 mL in 1 PACKAGE

NDC Product Information

Hydration Complex with NDC 43742-0099 is a a human over the counter drug product labeled by Deseret Biologicals, Inc.. The generic name of Hydration Complex is beta vulgaris, boldo, carduus benedictus, chelidonium majus, coffea tosta, equisetum arvense, petroselinum sativum, taraxacum officinale, hypericum perforatum, ginkgo biloba, kali muriaticum, kali phosphoricum, kali sulphuricum, germanium sesquioxide, silicea, calcarea fluorica, calcarea phosphorica. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Deseret Biologicals, Inc.

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.

Product Type: Human Otc Drug 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.

Hydration Complex Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BETA VULGARIS 1 [hp_X]/mL
  • PEUMUS BOLDUS LEAF 1 [hp_X]/mL
  • CENTAUREA BENEDICTA 1 [hp_X]/mL
  • CHELIDONIUM MAJUS 1 [hp_X]/mL
  • COFFEA ARABICA SEED, ROASTED 1 [hp_X]/mL
  • EQUISETUM ARVENSE TOP 1 [hp_X]/mL
  • PETROSELINUM CRISPUM 1 [hp_X]/mL
  • TARAXACUM OFFICINALE 1 [hp_X]/mL
  • HYPERICUM PERFORATUM 3 [hp_X]/mL
  • GINKGO 6 [hp_X]/mL
  • POTASSIUM CHLORIDE 6 [hp_X]/mL
  • POTASSIUM PHOSPHATE, DIBASIC 6 [hp_X]/mL
  • POTASSIUM SULFATE 6 [hp_X]/mL
  • GERMANIUM SESQUIOXIDE 8 [hp_X]/mL
  • SILICON DIOXIDE 8 [hp_X]/mL
  • CALCIUM FLUORIDE 8 [hp_X]/mL
  • TRIBASIC CALCIUM PHOSPHATE 8 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Deseret Biologicals, Inc.
Labeler Code: 43742
Marketing Category: UNAPPROVED HOMEOPATHIC - 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.

Start Marketing Date: 08-24-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Hydration Complex Product Label Images

Hydration Complex Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients:

Beta Vulgaris 1X, Boldo 1X, Carduus Benedictus 1X, Chelidonium Majus 1X, Coffea Tosta 1X, Equisetum Arvense 1X, Petroselinum Sativum 1X, Taraxacum Officinale 1X, Hypericum Perforatum 3X, Ginkgo Biloba 6X, Kali Muriaticum 6X, 12X, Kali Phosphoricum 6X, 12X, Kali Sulphuricum 6X, 12X, Germanium Sesquioxide 8X, Silicea 8X, Calcarea Fluorica 8X, 12X, Calcarea Phosphorica 8X, 12X.

Homeopathic Indications:

For temporary relief of low back pain, dry mouth, infrequent urination, headache, low energy levels.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

For temporary relief of low back pain, dry mouth, infrequent urination, headache, low energy levels.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.If pregnant or breast-feeding, seek advice of a health professional before use.Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

Directions:

10 drops per 8 oz water 3 times per day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized water, 25% Ethanol.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. In case of overdose, contact physician or Poison Control Center right away.

Questions:

Dist. By: Deseret Biologicals, Inc.469 W. Parkland DriveSandy, UT 84070www.desbio.com

Package Label Display:

DESBIONDC 43742-0099-1HOMEOPATHICHYDRATIONCOMPLEX2 FL OZ (60 ml)

* Please review the disclaimer below.

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