NDC 55714-4838

I-Waker

Apis Mellifica, Echinacea, Hydrastis Canadensis, Thuja Occidentalis, Aconitum Napellus, Agaricus Muscarius, Allium Sativum, Aloe, Arnica Montana, Arsenicum Album, Baptisia Tinctoria, Belladonna, Bryonia, Calcarea Carbonica, Calendula Officinalis, Capsicum Annuum, Carduus Marianus, Hepar Sulphuris Calcareum, Iodium, Lachesis Mutus, Lycopodium Clavatum, Mercurius Vivus, Nux Vomica, Phosphorus, Pulsatilla, Rhus Toxicodendron, Salvia Officinalis, Selenium Metallicum, Taraxacum Officinale, Tarentula Hispana,

I-Waker is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Newton Laboratories, Inc.. The primary component is Sage; Influenza B Virus; Anemone Pulsatilla; Azadirachta Indica Bark; Mercury; Strychnos Nux-vomica Seed; Ginger; Phosphorus; Bacillus Anthracis Immunoserum Rabbit; Selenium; Taraxacum Officinale; Lycosa Tarantula; Zinc; Toxicodendron Pubescens Leaf; Influenza A Virus; Apis Mellifera; Lycopodium Clavatum Spore; Goldenseal; Thuja Occidentalis Leafy Twig; Aconitum Napellus; Amanita Muscaria Fruiting Body; Garlic; Aloe; Arnica Montana; Arsenic Trioxide; Baptisia Tinctoria Root; Atropa Belladonna; Bryonia Alba Root; Oyster Shell Calcium Carbonate, Crude; Calendula Officinalis Flowering Top; Capsicum; Milk Thistle; Calcium Sulfide; Iodine; Lachesis Muta Venom; Echinacea, Unspecified.

Product ID55714-4838_9aa07f36-35e6-3c2c-e053-2a95a90a74f4
NDC55714-4838
Product TypeHuman Otc Drug
Proprietary NameI-Waker
Generic NameApis Mellifica, Echinacea, Hydrastis Canadensis, Thuja Occidentalis, Aconitum Napellus, Agaricus Muscarius, Allium Sativum, Aloe, Arnica Montana, Arsenicum Album, Baptisia Tinctoria, Belladonna, Bryonia, Calcarea Carbonica, Calendula Officinalis, Capsicum Annuum, Carduus Marianus, Hepar Sulphuris Calcareum, Iodium, Lachesis Mutus, Lycopodium Clavatum, Mercurius Vivus, Nux Vomica, Phosphorus, Pulsatilla, Rhus Toxicodendron, Salvia Officinalis, Selenium Metallicum, Taraxacum Officinale, Tarentula Hispana,
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2019-09-02
Marketing CategoryUNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
Labeler NameNewton Laboratories, Inc.
Substance NameSAGE; INFLUENZA B VIRUS; ANEMONE PULSATILLA; AZADIRACHTA INDICA BARK; MERCURY; STRYCHNOS NUX-VOMICA SEED; GINGER; PHOSPHORUS; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; SELENIUM; TARAXACUM OFFICINALE; LYCOSA TARANTULA; ZINC; TOXICODENDRON PUBESCENS LEAF; INFLUENZA A VIRUS; APIS MELLIFERA; LYCOPODIUM CLAVATUM SPORE; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG; ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; GARLIC; ALOE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; MILK THISTLE; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; ECHINACEA, UNSPECIFIED
Active Ingredient Strength15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55714-4838-2

50 mL in 1 BOTTLE, GLASS (55714-4838-2)
Marketing Start Date2020-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55714-4838-2 [55714483802]

I-Waker LIQUID
Marketing Categoryunapproved homeopathic
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-02

Drug Details

Active Ingredients

IngredientStrength
SAGE15 [hp_X]/mL

OpenFDA Data

SPL SET ID:9aa07f0c-a2ac-2178-e053-2a95a90aa5d8
Manufacturer
UNII

NDC Crossover Matching brand name "I-Waker" or generic name "Apis Mellifica, Echinacea, Hydrastis Canadensis, Thuja Occidentalis, Aconitum Napellus, Agaricus Muscarius, Allium Sativum, Aloe, Arnica Montana, Arsenicum Album, Baptisia Tinctoria, Belladonna, Bryonia, Calcarea Carbonica, Calendula Officinalis, Capsicum Annuum, Carduus Marianus, Hepar Sulphuris Calcareum, Iodium, Lachesis Mutus, Lycopodium Clavatum, Mercurius Vivus, Nux Vomica, Phosphorus, Pulsatilla, Rhus Toxicodendron, Salvia Officinalis, Selenium Metallicum, Taraxacum Officinale, Tarentula Hispana,"

NDCBrand NameGeneric Name
55714-2560I-WakerApis mellifica, Echinacea, Hydrastis canadensis, Thuja occidentalis, Aconitum napellus, Agaricus muscarius, Allium sativum, Aloe, Arnica montana, Arsenicum album, Baptisia tinctoria, Belladonna, Bryonia, Calcarea carbonica, Calendula officinalis, Capsicum annuum, Carduus marianus, Hepar sulphuris calcareum, Iodium, Lachesis mutus, Lycopodium clavatum, Mercurius vivus, Nux vomica, Phosphorus, Pulsatilla, Rhus toxicodendron, Salvia officinalis, Selenium metallicum, Taraxacum officinale, Tarentula hispana,
55714-4820I-WakerInfluenzinum, Anthracinum, Arnica, Belladonna, Aconitum nap., Arsenicum alb., Baptisia, Bryonia, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc. viv., Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Apis mel., Echinacea, Hydrastis, Thuja occ., Calcarea carbonica, Calendula, Capsicum, Carduus mar., Salvia, Selenium, Taraxacum, Zincum met., Zingiber, Azadirachta indica
55714-4838I-WakerApis mellifica, Echinacea, Hydrastis canadensis, Thuja occidentalis, Aconitum napellus, Agaricus muscarius, Allium sativum, Aloe, Arnica montana, Arsenicum album, Baptisia tinctoria, Belladonna, Bryonia, Calcarea carbonica, Calendula officinalis, Capsicum annuum, Carduus marianus, Hepar sulphuris calcareum, Iodium, Lachesis mutus, Lycopodium clavatum, Mercurius vivus, Nux vomica, Phosphorus, Pulsatilla, Rhus toxicodendron, Salvia officinalis, Selenium metallicum, Taraxacum officinale, Tarentula hispana,

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.