NDC 55714-4835 Food Additives

Iris Versicolor, Solidago Virgaurea, Aconitum Napellus, Agaricus Muscarius, Allium Cepa, Allium Sativum, Antimonium Crudum, Arsenicum Album, Baptisia Tinctoria, Bovista, Caffeinum, Capsicum Annuum, Cinchona Officinalis, Cinnamomum, Coccus Cacti, Cynara Scolymus, Fragaria Vesca, Gelsemium Sempervirens, Histaminum Hydrochloricum, Ipecacuanha, Jequerity, Juglans Regia, Lachesis Mutus, Ledum Palustre, Lycopodium Clavatum, Mentha Piperita, Natrum Muriaticum, Nux Moschata,

NDC Product Code 55714-4835

NDC CODE: 55714-4835

Proprietary Name: Food Additives 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: Iris Versicolor, Solidago Virgaurea, Aconitum Napellus, Agaricus Muscarius, Allium Cepa, Allium Sativum, Antimonium Crudum, Arsenicum Album, Baptisia Tinctoria, Bovista, Caffeinum, Capsicum Annuum, Cinchona Officinalis, Cinnamomum, Coccus Cacti, Cynara Scolymus, Fragaria Vesca, Gelsemium Sempervirens, Histaminum Hydrochloricum, Ipecacuanha, Jequerity, Juglans Regia, Lachesis Mutus, Ledum Palustre, Lycopodium Clavatum, Mentha Piperita, Natrum Muriaticum, Nux Moschata, 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.

NDC 55714-4835-1

Package Description: 30 mL in 1 BOTTLE, GLASS

NDC Product Information

Food Additives with NDC 55714-4835 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Food Additives is iris versicolor, solidago virgaurea, aconitum napellus, agaricus muscarius, allium cepa, allium sativum, antimonium crudum, arsenicum album, baptisia tinctoria, bovista, caffeinum, capsicum annuum, cinchona officinalis, cinnamomum, coccus cacti, cynara scolymus, fragaria vesca, gelsemium sempervirens, histaminum hydrochloricum, ipecacuanha, jequerity, juglans regia, lachesis mutus, ledum palustre, lycopodium clavatum, mentha piperita, natrum muriaticum, nux moschata, . 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.

Food Additives 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.

  • BLACK MUSTARD SEED 16 [hp_X]/mL
  • SOLANUM NIGRUM WHOLE 16 [hp_X]/mL
  • ANACARDIUM OCCIDENTALE FRUIT 16 [hp_X]/mL
  • SOLANUM LYCOPERSICUM 16 [hp_X]/mL
  • SODIUM NITRITE 16 [hp_X]/mL
  • SODIUM CHLORIDE 15 [hp_X]/mL
  • ANEMONE PULSATILLA 15 [hp_X]/mL
  • TOXICODENDRON PUBESCENS LEAF 15 [hp_X]/mL
  • ALLYLTHIOUREA 15 [hp_X]/mL
  • IRIS VERSICOLOR ROOT 6 [hp_X]/mL
  • IPECAC 15 [hp_X]/mL
  • ACONITUM NAPELLUS 15 [hp_X]/mL
  • AMANITA MUSCARIA FRUITING BODY 15 [hp_X]/mL
  • ONION 15 [hp_X]/mL
  • GARLIC 15 [hp_X]/mL
  • PHOSPHORUS 15 [hp_X]/mL
  • SACCHARIN 15 [hp_X]/mL
  • ANTIMONY TRISULFIDE 15 [hp_X]/mL
  • ARSENIC TRIOXIDE 15 [hp_X]/mL
  • BAPTISIA TINCTORIA ROOT 15 [hp_X]/mL
  • LYCOPERDON UTRIFORME FRUITING BODY 15 [hp_X]/mL
  • CAFFEINE 15 [hp_X]/mL
  • CAPSICUM 15 [hp_X]/mL
  • CINCHONA OFFICINALIS BARK 15 [hp_X]/mL
  • CINNAMON 15 [hp_X]/mL
  • PROTORTONIA CACTI 15 [hp_X]/mL
  • CYNARA SCOLYMUS LEAF 15 [hp_X]/mL
  • ALPINE STRAWBERRY 15 [hp_X]/mL
  • GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]/mL
  • HISTAMINE DIHYDROCHLORIDE 15 [hp_X]/mL
  • SOLIDAGO VIRGAUREA FLOWERING TOP 6 [hp_X]/mL
  • URTICA URENS 15 [hp_X]/mL
  • GINGER 15 [hp_X]/mL
  • SUCROSE 16 [hp_X]/mL
  • MENTHA PIPERITA 15 [hp_X]/mL
  • ABRUS PRECATORIUS SEED 15 [hp_X]/mL
  • JUGLANS REGIA LEAF 15 [hp_X]/mL
  • USTILAGO MAYDIS 15 [hp_X]/mL
  • LACHESIS MUTA VENOM 15 [hp_X]/mL
  • NUTMEG 15 [hp_X]/mL
  • PODOPHYLLUM 15 [hp_X]/mL
  • SULFUR 15 [hp_X]/mL
  • ASTACUS ASTACUS 16 [hp_X]/mL
  • GLYCYRRHIZA GLABRA 16 [hp_X]/mL
  • SOLANUM TUBEROSUM 16 [hp_X]/mL
  • SACCHAROMYCES CEREVISIAE 16 [hp_X]/mL
  • LACTOSE, UNSPECIFIED FORM 15 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 15 [hp_X]/mL
  • EGG SHELL, COOKED 15 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 15 [hp_X]/mL
  • RHODODENDRON TOMENTOSUM LEAFY TWIG 15 [hp_X]/mL
  • ASCORBIC ACID 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: 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: 09-02-2019 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Food Additives Product Label Images

Food Additives 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

Formulated for associated symptoms such as itching, swelling, headaches, indigestiion, vomiting and cramping.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or directed by a health professional.

Otc - Active Ingredient Section

Equal parts of Iris versicolor 6x, Solidago virgaurea 6x, Aconitum napellus 15x, Agaricus muscarius 15x, Allium cepa 15x, Allium sativum 15x, Antimonium crudum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bovista 15x, Caffeinum 15x, Capsicum annuum 15x, Cinchona officinalis 15x, Cinnamomum 15x, Coccus cacti 15x, Cynara scolymus 15x, Fragaria vesca 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, Ipecacuanha 15x, Jequerity 15x, Juglans regia 15x, Lachesis mutus 15x, Ledum palustre 15x, Lycopodium clavatum 15x, Mentha piperita 15x, Natrum muriaticum 15x, Nux moschata 15x, Ova tosta 15x, Phosphorus 15x, Podophyllum peltatum 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Saccharinum 15x, Saccharum lactis 15x, Sepia 15x, Sulphur 15x, Thiosinaminum 15x, Urtica urens 15x, Ustilago maidis 15x, Zingiber officinale 15x, Anacardium occidentale 16x, Ascorbicum acidum 16x, Astacus fluviatilis 16x, Glycyrrhiza glabra 16x, Lycopersicum esculentum 16x, Natrum nitricum 16x, Saccharum officinale 16x, Sinapis nigra 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Torula cerevisiae 16x.

Otc - Purpose Section

Formulated for associated symtoms such as itching, swelling, headaches, indigestion, vomiting and cramping.

Inactive Ingredient Section

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

Questions Section

Newtonlabs.net - Questions? 800.448.7256Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If
pregnant or breast-feeding, ask a doctor before use.

Otc - Pregnancy Or Breast Feeding Section

If
pregnant or breast-feeding, ask a doctor before use.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.