NDC 55714-2283 Teeth - Gums

Aconitum Nap., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium Majus, Crotalus Horridus, Gelsemium, Hepar Sulph. Calc., Kreosotum, Merc. Viv., Myrrha, Nux Vom., Phosphorus, Phytolacca, Plantago, Rhus Toxicodendron, Silicea, Staphysag., Echinacea

NDC Product Code 55714-2283

NDC Code: 55714-2283

Proprietary Name: Teeth - Gums 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: Aconitum Nap., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium Majus, Crotalus Horridus, Gelsemium, Hepar Sulph. Calc., Kreosotum, Merc. Viv., Myrrha, Nux Vom., Phosphorus, Phytolacca, Plantago, Rhus Toxicodendron, Silicea, Staphysag., Echinacea 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

  • 55714 - Newton Laboratories, Inc.
    • 55714-2283 - Teeth - Gums

NDC 55714-2283-0

Package Description: 7.08 g in 1 BOTTLE, GLASS

NDC 55714-2283-1

Package Description: 28.35 g in 1 BOTTLE, GLASS

NDC 55714-2283-2

Package Description: 56.7 g in 1 BOTTLE, GLASS

NDC Product Information

Teeth - Gums with NDC 55714-2283 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Teeth - Gums is aconitum nap., arnica, arsenicum alb., baptisia, belladonna, bryonia, calendula, chamomilla, chelidonium majus, crotalus horridus, gelsemium, hepar sulph. calc., kreosotum, merc. viv., myrrha, nux vom., phosphorus, phytolacca, plantago, rhus toxicodendron, silicea, staphysag., echinacea. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Newton Laboratories, Inc.

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

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.

Teeth - Gums 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.

  • ACONITUM NAPELLUS 15 [hp_X]/g
  • ARNICA MONTANA 15 [hp_X]/g
  • ARSENIC TRIOXIDE 15 [hp_X]/g
  • BAPTISIA TINCTORIA 15 [hp_X]/g
  • ATROPA BELLADONNA 15 [hp_X]/g
  • BRYONIA ALBA ROOT 15 [hp_X]/g
  • CALENDULA OFFICINALIS FLOWERING TOP 15 [hp_X]/g
  • MATRICARIA RECUTITA 15 [hp_X]/g
  • CHELIDONIUM MAJUS 15 [hp_X]/g
  • CROTALUS HORRIDUS HORRIDUS VENOM 15 [hp_X]/g
  • GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]/g
  • CALCIUM SULFIDE 15 [hp_X]/g
  • WOOD CREOSOTE 15 [hp_X]/g
  • MERCURY 15 [hp_X]/g
  • MYRRH 15 [hp_X]/g
  • STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/g
  • PHOSPHORUS 15 [hp_X]/g
  • PHYTOLACCA AMERICANA ROOT 15 [hp_X]/g
  • PLANTAGO MAJOR 15 [hp_X]/g
  • TOXICODENDRON PUBESCENS LEAF 15 [hp_X]/g
  • SILICON DIOXIDE 15 [hp_X]/g
  • DELPHINIUM STAPHISAGRIA SEED 15 [hp_X]/g
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/g

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.

  • SUCROSE (UNII: C151H8M554)

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: Newton Laboratories, Inc.
Labeler Code: 55714
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: 03-01-2011 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.

Teeth - Gums Product Label Images

Teeth - Gums 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

Indications & Usage Section

Teeth - Gums  Formulated for associated symptoms including mouth sores, bad breath, toothache, inflammation and gum sensitivity.

Dosage & Administration Section

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc - Active Ingredient Section

Aconitum nap. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Calendula 15x, Chamomilla 15x, Chelidonium majus 15x, Crotalus horridus 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Kreosotum15x, Merc. viv. 15x, Myrrha 15x, Nux vom. 15x, Phosphorus 15x, Phytolacca 15x, Plantago 15x, Rhus toxicodendron 15x, Silicea 15x, Staphysag. 15x, Chamomilla 3x, Echinacea 3x.

Otc - Purpose Section

Formulated for associated symptoms including mouth sores, bad breath, toothache, inflammation and gum sensitivity.

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Questions Section

Www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012Questions?  1.800.448.7256

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.

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