NDC 43742-1511 Oral Health

Borax, Bryonia (alba), Echinacea Purpurea, Juglans Cinerea, Kali Muriaticum, Magnesia Muriatica, Muriaticum Acidum, Discus Intervertebralis Suis, Oral Mucosa (suis), Antimonium Crudum, Arsenicum Album, Bismuthum Subnitricum, Chamomilla, Cinchona Officinalis, Nux Moschata, Sambucus Nigra, Sepia, Mercurius Solubilis, Calcarea Phosphorica, Ignatia Amara, Oxygenium, Candida Albicans

NDC Product Code 43742-1511

NDC Code: 43742-1511

Proprietary Name: Oral Health 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: Borax, Bryonia (alba), Echinacea Purpurea, Juglans Cinerea, Kali Muriaticum, Magnesia Muriatica, Muriaticum Acidum, Discus Intervertebralis Suis, Oral Mucosa (suis), Antimonium Crudum, Arsenicum Album, Bismuthum Subnitricum, Chamomilla, Cinchona Officinalis, Nux Moschata, Sambucus Nigra, Sepia, Mercurius Solubilis, Calcarea Phosphorica, Ignatia Amara, Oxygenium, Candida Albicans 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.

NDC 43742-1511-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Oral Health with NDC 43742-1511 is a a human over the counter drug product labeled by Deseret Biologicals, Inc.. The generic name of Oral Health is borax, bryonia (alba), echinacea purpurea, juglans cinerea, kali muriaticum, magnesia muriatica, muriaticum acidum, discus intervertebralis suis, oral mucosa (suis), antimonium crudum, arsenicum album, bismuthum subnitricum, chamomilla, cinchona officinalis, nux moschata, sambucus nigra, sepia, mercurius solubilis, calcarea phosphorica, ignatia amara, oxygenium, candida albicans. 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.

Oral Health 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.

  • SODIUM BORATE 6 [hp_X]/mL
  • BRYONIA ALBA ROOT 6 [hp_X]/mL
  • ECHINACEA PURPUREA 6 [hp_X]/mL
  • JUGLANS CINEREA BRANCH BARK/ROOT BARK 6 [hp_X]/mL
  • POTASSIUM CHLORIDE 6 [hp_X]/mL
  • MAGNESIUM CHLORIDE 6 [hp_X]/mL
  • HYDROCHLORIC ACID 6 [hp_X]/mL
  • SUS SCROFA INTERVERTEBRAL DISC 8 [hp_X]/mL
  • SUS SCROFA ORAL MUCOSA 8 [hp_X]/mL
  • ANTIMONY TRISULFIDE 12 [hp_X]/mL
  • ARSENIC TRIOXIDE 12 [hp_X]/mL
  • BISMUTH SUBNITRATE 12 [hp_X]/mL
  • MATRICARIA CHAMOMILLA 12 [hp_X]/mL
  • CINCHONA OFFICINALIS BARK 12 [hp_X]/mL
  • NUTMEG 12 [hp_X]/mL
  • SAMBUCUS NIGRA FLOWERING TOP 12 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 12 [hp_X]/mL
  • MERCURIUS SOLUBILIS 12 [hp_X]/mL
  • TRIBASIC CALCIUM PHOSPHATE 12 [hp_X]/mL
  • STRYCHNOS IGNATII SEED 12 [hp_X]/mL
  • OXYGEN 16 [hp_X]/mL
  • CANDIDA ALBICANS 16 [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: 08-20-2019 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: 12-31-2020 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.

Oral Health Product Label Images

Oral Health 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:

Borax 6X, Bryonia (Alba) 6X, Echinacea Purpurea 6X, Juglans Cinerea 6X, Kali Muriaticum 6X, Magnesia Muriatica 6X, Muriaticum Acidum 6X, Discus Intervertebralis Suis 8X, 12X, 18X, 24X, 30X, Oral Mucosa (Suis) 8X, 12X, 18X, 24X, 30X, Antimonium Crudum 12X, Arsenicum Album 12X, Bismuthum Subnitricum 12X, Chamomilla 12X, Cinchona Officinalis 12X, Nux Moschata 12X, Sambucus Nigra 12X, Sepia 12X, Mercurius Solubilis 12X, 18X, 24X, 30X, Calcarea Phosphorica 12X, 18X, 30X, Ignatia Amara 12X, 30X, Oxygenium 16X, Candida Albicans 16X, 18X, 24X, 30X.

Homeopathic Indications:

For temporary relief of symptoms related to oral health, such as cavitation, delayed dentition, dry mouth, painful eating, eruptions on the tongue and inner cheeks and tooth sensitivity.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

For temporary relief of symptoms related to oral health, such as cavitation, delayed dentition, dry mouth, painful eating, eruptions on the tongue and inner cheeks and tooth sensitivity.****These statements are based upon traditional homeopathic principles. 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.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

Directions:

1-10 drops under the tongue, 3 times a 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.

Questions:

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

Package Label Display:

DESBIONDC 43742-1511-1HOMEOPATHICORALHEALTH1 FL OZ (30 ml)

* Please review the disclaimer below.