NDC 55714-2258 Tobacco Withdrawal

Arsenicum Alb., Benzoicum Acidum, Berber. Vulg., Bryonia, Caladium Seguinum, Cantharis, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Daphne Indica, Ignatia, Iris Versicolor, Lycopodium, Nicotinum, Nux Vom., Rhus Toxicodendron, Scutellaria Lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana

NDC Product Code 55714-2258

NDC Code: 55714-2258

Proprietary Name: Tobacco Withdrawal 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: Arsenicum Alb., Benzoicum Acidum, Berber. Vulg., Bryonia, Caladium Seguinum, Cantharis, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Daphne Indica, Ignatia, Iris Versicolor, Lycopodium, Nicotinum, Nux Vom., Rhus Toxicodendron, Scutellaria Lateriflora, Tabacum, Echinacea, Taraxacum, 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.
    • 55714-2258 - Tobacco Withdrawal

NDC 55714-2258-0

Package Description: .5 mL in 1 BOTTLE, GLASS

NDC 55714-2258-1

Package Description: 29.57 mL in 1 BOTTLE, GLASS

NDC 55714-2258-2

Package Description: 59.14 mL in 1 BOTTLE, GLASS

NDC Product Information

Tobacco Withdrawal with NDC 55714-2258 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Tobacco Withdrawal is arsenicum alb., benzoicum acidum, berber. vulg., bryonia, caladium seguinum, cantharis, ceanothus, chelidonium majus, chionanthus virginica, cinchona, daphne indica, ignatia, iris versicolor, lycopodium, nicotinum, nux vom., rhus toxicodendron, scutellaria lateriflora, tabacum, echinacea, taraxacum, 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.

Tobacco Withdrawal 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.

  • ARSENIC TRIOXIDE 15 [hp_X]/mL
  • BENZOIC ACID 15 [hp_X]/mL
  • BERBERIS VULGARIS ROOT BARK 15 [hp_X]/mL
  • BRYONIA ALBA ROOT 15 [hp_X]/mL
  • DIEFFENBACHIA SEGUINE 15 [hp_X]/mL
  • LYTTA VESICATORIA 15 [hp_X]/mL
  • CEANOTHUS AMERICANUS LEAF 15 [hp_X]/mL
  • CHELIDONIUM MAJUS 15 [hp_X]/mL
  • CHIONANTHUS VIRGINICUS BARK 15 [hp_X]/mL
  • CINCHONA OFFICINALIS BARK 15 [hp_X]/mL
  • DAPHNE ODORA BARK 15 [hp_X]/mL
  • STRYCHNOS IGNATII SEED 15 [hp_X]/mL
  • IRIS VERSICOLOR ROOT 15 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 15 [hp_X]/mL
  • NICOTINE 15 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/mL
  • TOXICODENDRON PUBESCENS LEAF 15 [hp_X]/mL
  • SCUTELLARIA LATERIFLORA 15 [hp_X]/mL
  • TOBACCO LEAF 15 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/mL
  • TARAXACUM OFFICINALE 3 [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.

Tobacco Withdrawal Product Label Images

Tobacco Withdrawal 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

Tobacco Withdrawal  Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.  Adults, take 6 drops orally 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

Arsenicum alb. 15x, Benzoicum acidum 15x, Berber. vulg. 15x, Bryonia 15x, Caladium seguinum 15x, Cantharis 15x, Ceanothus 15x, Chelidonium majus 15x, Chionanthus virginica 15x, Cinchona 15x, Daphne indica 15x, Ignatia 15x, Iris versicolor 15x, Lycopodium 15x, Nicotinum 15x, Nux vom. 15x, Rhus toxicodendron 15x, Scutellaria lateriflora 15x, Tabacum 15x, Echinacea 3x, Taraxacum 3x, Valeriana 3x.

Otc - Purpose Section

Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

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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