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,

Newton Laboratories, Inc.
Human Otc Drug
NDC 55714-2545

Food Additives also known as 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, is a human otc drug labeled by 'Newton Laboratories, Inc.'. National Drug Code (NDC) number for Food Additives is 55714-2545. This drug is available in dosage form of Pellet. The names of the active, medicinal ingredients in Food Additives drug includes Abrus Precatorius Seed - 15 [hp_X]/g Aconitum Napellus - 15 [hp_X]/g Allylthiourea - 15 [hp_X]/g Alpine Strawberry - 15 [hp_X]/g Amanita Muscaria Fruiting Body - 15 [hp_X]/g Anacardium Occidentale Fruit - 16 [hp_X]/g Anemone Pulsatilla - 15 [hp_X]/g Antimony Trisulfide - 15 [hp_X]/g Arsenic Trioxide - 15 [hp_X]/g Ascorbic Acid - 16 [hp_X]/g and more. The currest status of Food Additives drug is Active.

Drug Information:

Drug NDC:	55714-2545
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Food Additives
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
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,
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Newton Laboratories, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Pellet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ABRUS PRECATORIUS SEED - 15 [hp_X]/g ACONITUM NAPELLUS - 15 [hp_X]/g ALLYLTHIOUREA - 15 [hp_X]/g ALPINE STRAWBERRY - 15 [hp_X]/g AMANITA MUSCARIA FRUITING BODY - 15 [hp_X]/g ANACARDIUM OCCIDENTALE FRUIT - 16 [hp_X]/g ANEMONE PULSATILLA - 15 [hp_X]/g ANTIMONY TRISULFIDE - 15 [hp_X]/g ARSENIC TRIOXIDE - 15 [hp_X]/g ASCORBIC ACID - 16 [hp_X]/g Load more... ASTACUS ASTACUS - 16 [hp_X]/g BAPTISIA TINCTORIA ROOT - 15 [hp_X]/g BLACK MUSTARD SEED - 16 [hp_X]/g CAFFEINE - 15 [hp_X]/g CAPSICUM - 15 [hp_X]/g CINCHONA OFFICINALIS BARK - 15 [hp_X]/g CINNAMON - 15 [hp_X]/g CYNARA SCOLYMUS LEAF - 15 [hp_X]/g EGG SHELL, COOKED - 15 [hp_X]/g GARLIC - 15 [hp_X]/g GELSEMIUM SEMPERVIRENS ROOT - 15 [hp_X]/g GINGER - 15 [hp_X]/g GLYCYRRHIZA GLABRA - 16 [hp_X]/g HISTAMINE DIHYDROCHLORIDE - 15 [hp_X]/g IPECAC - 15 [hp_X]/g IRIS VERSICOLOR ROOT - 6 [hp_X]/g JUGLANS REGIA LEAF - 15 [hp_X]/g LACHESIS MUTA VENOM - 15 [hp_X]/g LACTOSE, UNSPECIFIED FORM - 15 [hp_X]/g LYCOPERDON UTRIFORME FRUITING BODY - 15 [hp_X]/g LYCOPODIUM CLAVATUM SPORE - 15 [hp_X]/g MENTHA PIPERITA - 15 [hp_X]/g NUTMEG - 15 [hp_X]/g ONION - 15 [hp_X]/g PHOSPHORUS - 15 [hp_X]/g PODOPHYLLUM - 15 [hp_X]/g PROTORTONIA CACTI - 15 [hp_X]/g RHODODENDRON TOMENTOSUM LEAFY TWIG - 15 [hp_X]/g SACCHARIN - 15 [hp_X]/g SACCHAROMYCES CEREVISIAE - 16 [hp_X]/g SEPIA OFFICINALIS JUICE - 15 [hp_X]/g SODIUM CHLORIDE - 15 [hp_X]/g SODIUM NITRITE - 16 [hp_X]/g SOLANUM LYCOPERSICUM - 16 [hp_X]/g SOLANUM NIGRUM WHOLE - 16 [hp_X]/g SOLANUM TUBEROSUM - 16 [hp_X]/g SOLIDAGO VIRGAUREA FLOWERING TOP - 6 [hp_X]/g SUCROSE - 16 [hp_X]/g SULFUR - 15 [hp_X]/g TOXICODENDRON PUBESCENS LEAF - 15 [hp_X]/g URTICA URENS - 15 [hp_X]/g USTILAGO MAYDIS - 15 [hp_X]/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	01 Jul, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	08 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Newton Laboratories, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000193618 M0001797 N0000175739 N0000175729 N0000175790 M0023046 N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0022575 M0008672 M0516536 N0000185372 N0000185001 M0008890
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	3OM8I6L7CD U0NQ8555JD 706IDJ14B7 CG6IX3GCMU DIF093I037 4A10JR4E7E I76KB35JEV F79059A38U S7V92P67HO PQ6CK8PD0R Load more... V0551986XQ 5EF0HWI5WU 8LTY55LQ8D 3G6A5W338E 00UK7646FG S003A158SB 5S29HWU6QB B71UA545DE 24HBF856C8 V1V998DC17 639KR60Q1Q C5529G5JPQ 2788Z9758H 3POA0Q644U 62I3C8233L X43D4L3DQC 85HKB87105 VSW71SS07I J2B2A4N98G K2A74U428F C88X29Y479 79M2M2UDA9 AEE24M3MQ9 492225Q21H 27YLU75U4W 2S713A4VP3 LZB7TFX1LT 877L01IZ0P FST467XS7D 978D8U419H QDL83WN8C2 451W47IQ8X M0KG633D4F 0243Q4990L 0FMD6WV47M 2A8I57T4MX 5405K23S50 C151H8M554 70FD1KFU70 6IO182RP7A IHN2NQ5OF9 4K7Z7K7SWG
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Vitamin C [EPC] Central Nervous System Stimulant [EPC] Methylxanthine [EPC] Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Central Nervous System Stimulation [PE] Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Ascorbic Acid [CS] Xanthines [CS] Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Vegetable Proteins [CS] Food Additives [CS] Seed Storage Proteins [CS] Fungal Proteins [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Ascorbic Acid [CS] Cell-mediated Immunity [PE] Central Nervous System Stimulant [EPC] Central Nervous System Stimulation [PE] Dietary Proteins [CS] Food Additives [CS] Fungal Proteins [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Methylxanthine [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Seed Storage Proteins [CS] Vegetable Proteins [CS] Vitamin C [EPC] Xanthines [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
55714-2545-1	28 g in 1 BOTTLE, GLASS (55714-2545-1)	01 Jul, 2019	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Food Additives

Iris Versicolor & more..

Liquid
Newton Laboratories, Inc.
NDC: 55714-2544

Food Additives

Iris Versicolor & more..

Pellet
Newton Laboratories, Inc.
NDC: 55714-2545

Food Additives

Iris Versicolor & more..

Liquid
Newton Laboratories, Inc.
NDC: 55714-4835

Purpose:

Otc - purpose section formulated for associated symtoms such as itching, swelling, headaches, indigestion, vomiting and cramping.

Product Elements:

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, arsenic trioxide arsenic cation (3+) baptisia tinctoria root baptisia tinctoria root lycoperdon utriforme fruiting body lycoperdon utriforme fruiting body caffeine caffeine capsicum capsicum cinchona officinalis bark cinchona officinalis bark cinnamon cinnamon protortonia cacti protortonia cacti cynara scolymus leaf cynara scolymus leaf alpine strawberry alpine strawberry gelsemium sempervirens root gelsemium sempervirens root histamine dihydrochloride histamine solidago virgaurea flowering top solidago virgaurea flowering top urtica urens urtica urens ginger ginger mentha piperita mentha piperita abrus precatorius seed abrus precatorius seed juglans regia leaf juglans regia leaf ustilago maydis ustilago maydis lachesis muta venom lachesis muta venom nutmeg nutmeg podophyllum podophyllum sulfur sulfur astacus astacus astacus astacus glycyrrhiza glabra glycyrrhiza glabra solanum tuberosum solanum tuberosum saccharomyces cerevisiae saccharomyces cerevisiae lactose, unspecified form anhydrous lactose sepia officinalis juice sepia officinalis juice sucrose caramel sucrose sucrose egg shell, cooked egg shell, cooked lycopodium clavatum spore lycopodium clavatum spore rhododendron tomentosum leafy twig rhododendron tomentosum leafy twig ascorbic acid ascorbic acid black mustard seed black mustard seed solanum nigrum whole solanum nigrum whole anacardium occidentale fruit anacardium occidentale fruit solanum lycopersicum solanum lycopersicum sodium nitrite nitrite ion sodium chloride chloride ion anemone pulsatilla anemone pulsatilla toxicodendron pubescens leaf toxicodendron pubescens leaf allylthiourea allylthiourea iris versicolor root iris versicolor root ipecac ipecac aconitum napellus aconitum napellus amanita muscaria fruiting body amanita muscaria fruiting body onion onion garlic garlic phosphorus phosphorus saccharin saccharin antimony trisulfide antimony cation (3+)

Indications and Usage:

Indications & usage section formulated for associated symptoms such as itching, swelling, headaches, indigestiion, vomiting and cramping.

Warnings:

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.

Dosage and Administration:

Dosage & administration section directions: ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or directed by a health professional. under age 2, crush/dissolve pellets in purified water. sensitive persons begin with 1 pellet and gradually increase to full dose.

Package Label Principal Display Panel:

Package label package label

Further Questions:

Questions section newtonlabs.net - questions? 800.448.7256 newton laboratories, inc. fda est # 1051203 conyers, ga 30013

Comments/ Reviews:

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