NDC 55714-1509 Teething - Colic

Aconitum Nap., Apis Mel., Baptisia, Belladonna, Borax, Bryonia, Calc. Carb., Calc. Phos., Chamomilla, Chelidonium Majus, Coffea Cruda, Collinsonia, Colocynthis, Kreosotum, Mag.phos., Nux Vom., Podoph. Pelt., Rheum, Scutellarialateriflora, Silicea, Terebinthina, Zingiber, Valeriana

NDC Product Code 55714-1509

NDC Code: 55714-1509

Proprietary Name: Teething - Colic 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., Apis Mel., Baptisia, Belladonna, Borax, Bryonia, Calc. Carb., Calc. Phos., Chamomilla, Chelidonium Majus, Coffea Cruda, Collinsonia, Colocynthis, Kreosotum, Mag.phos., Nux Vom., Podoph. Pelt., Rheum, Scutellarialateriflora, Silicea, Terebinthina, Zingiber, Valeriana 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.
    • 55714-1509 - Teething - Colic

NDC 55714-1509-0

Package Description: .5 mL in 1 BOTTLE, GLASS

NDC 55714-1509-1

Package Description: 29.57 mL in 1 BOTTLE, GLASS

NDC 55714-1509-2

Package Description: 59.14 mL in 1 BOTTLE, GLASS

NDC Product Information

Teething - Colic with NDC 55714-1509 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Teething - Colic is aconitum nap., apis mel., baptisia, belladonna, borax, bryonia, calc. carb., calc. phos., chamomilla, chelidonium majus, coffea cruda, collinsonia, colocynthis, kreosotum, mag.phos., nux vom., podoph. pelt., rheum, scutellarialateriflora, silicea, terebinthina, zingiber, valeriana. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Newton Laboratories, 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.

Teething - Colic 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 10 [hp_X]/mL
  • APIS MELLIFERA 10 [hp_X]/mL
  • BAPTISIA TINCTORIA 10 [hp_X]/mL
  • ATROPA BELLADONNA 10 [hp_X]/mL
  • SODIUM BORATE 10 [hp_X]/mL
  • BRYONIA ALBA ROOT 10 [hp_X]/mL
  • OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X]/mL
  • TRIBASIC CALCIUM PHOSPHATE 10 [hp_X]/mL
  • MATRICARIA RECUTITA 10 [hp_X]/mL
  • CHELIDONIUM MAJUS 10 [hp_X]/mL
  • ARABICA COFFEE BEAN 10 [hp_X]/mL
  • COLLINSONIA CANADENSIS ROOT 10 [hp_X]/mL
  • CITRULLUS COLOCYNTHIS FRUIT PULP 10 [hp_X]/mL
  • WOOD CREOSOTE 10 [hp_X]/mL
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 10 [hp_X]/mL
  • PODOPHYLLUM 10 [hp_X]/mL
  • RHEUM OFFICINALE ROOT 10 [hp_X]/mL
  • SCUTELLARIA LATERIFLORA 10 [hp_X]/mL
  • SILICON DIOXIDE 10 [hp_X]/mL
  • TURPENTINE OIL 10 [hp_X]/mL
  • GINGER 10 [hp_X]/mL
  • VALERIAN 3 [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.

  • 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: 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.

Teething - Colic Product Label Images

Teething - Colic 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

Teething - Colic   Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.   Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc - Active Ingredient Section

Aconitum nap. 10x, Apis mel. 10x, Baptisia 10x, Belladonna 10x, Borax 10x, Bryonia 10x, Calc. carb.10x, Calc. phos. 10x, Chamomilla 10x, Chelidonium majus 10x, Coffea cruda 10x, Collinsonia 10x, Colocynthis 10x, Kreosotum 10x, Mag.phos. 10x, Nux vom. 10x, Podoph. pelt. 10x, Rheum 10x, Scutellaria lateriflora 10x, Silicea 10x, Terebinthina 10x, Zingiber 10x, Chamomilla 3x, Valeriana 3x.

Otc - Purpose Section

Formulated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and digestive discomfort.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

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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