{
"NDC": [
{
"NDCCode": "49726-041-60",
"PackageDescription": "60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (49726-041-60) ",
"NDC11Code": "49726-0041-60",
"ProductNDC": "49726-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Synaptol",
"NonProprietaryName": "Aconitum Ferox, Adrenalinum, Aesculus Hippocastanum, Flos, Apis Mellifica, Argentum Nitricum, Avena Sativa, Baptisia Tinctoria, Cochlearia Armoracia, Phosphorus, Scleranthus Annuus, Flos, Scutellaria Lateriflora, Sumbul, Viola Odorata",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; EPINEPHRINE; FERULA SUMBUL ROOT; HORSERADISH; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; VIOLA ODORATA",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171211",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of hyperactivity & inattention symptoms including. poor focus. impulsivity. difficulty concentrating when reading or writing. Product indications based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-038-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-038-60) ",
"NDC11Code": "49726-0038-60",
"ProductNDC": "49726-038",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anxietin",
"NonProprietaryName": "Aconitum Napellus, Alfalfa, Argentum Nitricum, Aurum Metallicum, Avena Sativa, Baryta Carbonica, Calcarea Phosphorica, Chamomilla, Gelsemium Sempervirens, Glonoinum, Humulus Lupulus, Ignatia Amara, Kali Phosphoricum, Muriaticum Acidum, Natrum Phosphoricum, Passiflora Incarnata, Phosphorus, Staphysagria, Stramonium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180416",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; ALFALFA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIBASIC POTASSIUM PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HOPS; HYDROCHLORIC ACID; MATRICARIA CHAMOMILLA; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; SILVER NITRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS IGNATII SEED; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180416",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. anxiousness. social fear. panic. hypersensitivity. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-039-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-039-60) ",
"NDC11Code": "49726-0039-60",
"ProductNDC": "49726-039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Moodbrite",
"NonProprietaryName": "Anacardium Orientale, Avena Sativa, Aurum Metallicum, Calcarea Carbonica, Carpinus Betulus, Flos, Cimicifuga Racemosa, Cinchona Officinalis, Hypericum Perforatum, Ignatia Amara, Kali Bromatum, Larix Decidua, Flos, Natrum Carbonicum, Natrum Sulphuricum, Phosphoricum Acidum, Phosphorus, Pulsatilla (vulgaris), Sepia, Sinapis Arvensis, Flos, Tabacum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180416",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ANEMONE PULSATILLA; AVENA SATIVA FLOWERING TOP; BLACK COHOSH; CARPINUS BETULUS FLOWERING TOP; CINCHONA OFFICINALIS BARK; GOLD; HYPERICUM PERFORATUM; LARIX DECIDUA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM BROMIDE; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; TOBACCO LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180416",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. sadness. loss of interest. poor self-esteem. low motivation. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-040-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-040-60) ",
"NDC11Code": "49726-0040-60",
"ProductNDC": "49726-040",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Respitrol",
"NonProprietaryName": "Ammonium Carbonicum, Antimonium Tartaricum, Bromium, Carbo Vegetabilis, Chlorinum, Kali Carbonicum, Lobelia Inflata, Stannum Metallicum, Sulphuricum Acidum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180615",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACTIVATED CHARCOAL; AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; BROMINE; CHLORINE; LOBELIA INFLATA; POTASSIUM CARBONATE; SULFURIC ACID; TIN",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180615",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as: tightness in chest, shortness of breath, cough, or wheezing. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-042-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-042-60) ",
"NDC11Code": "49726-0042-60",
"ProductNDC": "49726-042",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Compulsin",
"NonProprietaryName": "Calcarea Carbonica, Coffea Cruda, Iodium, Mancinella, Physostigma Venenosum, Silicea, Ulmus Procera, Flos",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181015",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ARABICA COFFEE BEAN; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE; ULMUS MINOR FLOWERING TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181015",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. nervous, repetitive thoughts. disproportionate fears. nervous, repetitive behaviors apprehensiveness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-043-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-043-60) ",
"NDC11Code": "49726-0043-60",
"ProductNDC": "49726-043",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Activive",
"NonProprietaryName": "Alfalfa, Ambra Grisea, Anacardium Orientale, Argentum Nitricum, Aurum Metallicum, Avena Sativa, Caladium Seguinum, Calcarea Carbonica, Cocculus Indicus, Gelsemium Sempervirens, Ignatia Amara, Kali Phosphoricum, Lycopodium Clavatum, Natrum Muriaticum, Nux Moschata, Phosphoricum Acidum, Phosphorus, Selenium Metallicum, Sepia, Silicea, Sulphur",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181019",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ALFALFA; AMBERGRIS; ANAMIRTA COCCULUS SEED; AVENA SATIVA FLOWERING TOP; DIBASIC POTASSIUM PHOSPHATE; DIEFFENBACHIA SEGUINE; GELSEMIUM SEMPERVIRENS ROOT; GOLD; LYCOPODIUM CLAVATUM SPORE; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; SULFUR",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181019",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. exhaustion. dullness. drowsiness. muscle weakness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-044-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-044-60) ",
"NDC11Code": "49726-0044-60",
"ProductNDC": "49726-044",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neuroveen",
"NonProprietaryName": "Aconitum Napellus, Agaricus Muscarius, Baryta Muriatica, Calendula Officinalis, Carbo Vegetabilis, Carduus Marianus, Chamomilla, Dulcamara, Glonoinum, Hamamelis Virginiana, Lycopersicum Esculentum, Magnesia Phosphorica, Phosphorus, Rhus Tox, Secale Cornutum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181015",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; ACTIVATED CHARCOAL; AMANITA MUSCARIA FRUITING BODY; BARIUM CHLORIDE DIHYDRATE; CALENDULA OFFICINALIS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; NITROGLYCERIN; PHOSPHORUS; SILYBUM MARIANUM SEED; SOLANUM DULCAMARA TOP; TOMATO; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vasodilation [PE], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181015",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of nerve pain symptoms including: itching numbness swelling burning cramping tingling Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-045-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-045-60) ",
"NDC11Code": "49726-0045-60",
"ProductNDC": "49726-045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rhumatol",
"NonProprietaryName": "Actaea Spicata, Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia (alba), Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Ledum Palustre, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla (pratensis), Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Zincum Metallicumk",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190723",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACTAEA SPICATA ROOT; ANEMONE PRATENSIS; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HORSE CHESTNUT; HYPERICUM PERFORATUM; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Mood Stabilizer [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190723",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. pain. inflammation. stiffness. swelling. weakness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-046-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-046-60) ",
"NDC11Code": "49726-0046-60",
"ProductNDC": "49726-046",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Painazol",
"NonProprietaryName": "Actaea Spicata, Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia (alba), Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Hypericum Perforatum, Ledum Palustre, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla (pratensis), Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Sulphur, Zincum Metallicum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190528",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACTAEA SPICATA ROOT; ANEMONE PRATENSIS; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HORSE CHESTNUT; HYPERICUM PERFORATUM; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; SULFUR; TOXICODENDRON PUBESCENS LEAF; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Mood Stabilizer [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190528",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. pain. burning. weakness. sensitivity. tingling. numbness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-047-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49726-047-60) ",
"NDC11Code": "49726-0047-60",
"ProductNDC": "49726-047",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Restulex",
"NonProprietaryName": "Bufo Rana, Causticum, Chamomilla, Crotalus Horridus, Digitalis Purpurea, Lachesis Mutus, Lilium Tigrinum, Pulsatilla (pratensis) Rhus Tox, Sulphur, Tarentula Hispana, Viscum Album, Zincum Metallicum.",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191010",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ANEMONE PRATENSIS; BUFO BUFO CUTANEOUS GLAND; CAUSTICUM; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOSA TARANTULA; MATRICARIA CHAMOMILLA; SULFUR; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUIT; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191010",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms such as. twitching. burning. heaviness. jerking. cramping. pain. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "49726-048-60",
"PackageDescription": "60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (49726-048-60) ",
"NDC11Code": "49726-0048-60",
"ProductNDC": "49726-048",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Synaptol Lactose Free",
"NonProprietaryName": "Aconitum Ferox, Adrenalinum, Aesculus Hippocastanum, Flos, Apis Mellifica, Argentum Nitricum, Avena Sativa, Baptisia Tinctoria, Cochlearia Armoracia, Phosphorus, Scleranthus Annuus, Flos, Scutellaria Lateriflora, Sumbul, Viola Odorata",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20220927",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HelloLife, Inc.",
"SubstanceName": "ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; EPINEPHRINE; FERULA SUMBUL ROOT; HORSERADISH; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA WHOLE; SILVER NITRATE; VIOLA ODORATA WHOLE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220927",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of hyperactivity & inattention symptoms including. poor focus. impulsivity. fidgeting. difficulty concentrating when reading or writing. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA."
},
{
"NDCCode": "16714-041-02",
"PackageDescription": "60 TABLET in 1 BOTTLE (16714-041-02)",
"NDC11Code": "16714-0041-02",
"ProductNDC": "16714-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078253",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "16714-041-08",
"PackageDescription": "60 TABLET in 1 BOTTLE (16714-041-08)",
"NDC11Code": "16714-0041-08",
"ProductNDC": "16714-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078253",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "21130-041-60",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (21130-041-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "21130-0041-60",
"ProductNDC": "21130-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener Laxative",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210131",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Safeway, Inc.",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210131",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity) . generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "33342-041-98",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (33342-041-98) / 60 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "33342-0041-98",
"ProductNDC": "33342-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202255",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230419",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil Tablets, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3 d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4 methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets, USP are formulated as white to off-white, diamond shaped film-coated tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate and microcrystalline cellulose. The film coating ingredient contains: Hypromellose, titanium dioxide, triacetin."
},
{
"NDCCode": "42708-041-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42708-041-60) ",
"NDC11Code": "42708-0041-60",
"ProductNDC": "42708-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "QPharma Inc",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180330",
"SamplePackage": "Y",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3) .",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
},
{
"NDCCode": "43353-041-53",
"PackageDescription": "60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-53)",
"NDC11Code": "43353-0041-53",
"ProductNDC": "43353-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120626",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231"
},
{
"NDCCode": "43353-041-60",
"PackageDescription": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-60)",
"NDC11Code": "43353-0041-60",
"ProductNDC": "43353-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120626",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231"
},
{
"NDCCode": "46084-041-14",
"PackageDescription": "60 TABLET in 1 BLISTER PACK (46084-041-14)",
"NDC11Code": "46084-0041-14",
"ProductNDC": "46084-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aphenap",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "A P J Laboratories Limited",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose."
},
{
"NDCCode": "59078-041-01",
"PackageDescription": "60 g in 1 CARTON (59078-041-01)",
"NDC11Code": "59078-0041-01",
"ProductNDC": "59078-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uv Sunset Waterproof Sun Block",
"NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "TONYMOLY CO., LTD.",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "8.06; 2.1",
"StrengthUnit": "g/60g; g/60g",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63187-041-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-041-60) ",
"NDC11Code": "63187-0041-60",
"ProductNDC": "63187-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19960308",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA020254",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N"
},
{
"NDCCode": "63379-041-01",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (63379-041-01) ",
"NDC11Code": "63379-0041-01",
"ProductNDC": "63379-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziagen",
"NonProprietaryName": "Abacavir Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19981229",
"MarketingCategoryName": "APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
"ApplicationNumber": "NDA020977",
"LabelerName": "Glaxo Operations UK Ltd",
"SubstanceName": "ABACAVIR SULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "69731-041-24",
"PackageDescription": "60 mL in 1 BOTTLE (69731-041-24) ",
"NDC11Code": "69731-0041-24",
"ProductNDC": "69731-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Safmaxx Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "G&N Enterprise,LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 handwash to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "70005-041-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (70005-041-01) > 60 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "70005-0041-01",
"ProductNDC": "70005-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20160817",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "We Care Distributors Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "temporarily reduces fever. temporarily relieves minor aches and pains due to:. the common cold . flu . headache . sore throat . toothache."
},
{
"NDCCode": "70934-041-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (70934-041-60) ",
"NDC11Code": "70934-0041-60",
"ProductNDC": "70934-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065062",
"LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20171030",
"SamplePackage": "N"
},
{
"NDCCode": "71205-041-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (71205-041-60) ",
"NDC11Code": "71205-0041-60",
"ProductNDC": "71205-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075795",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180501",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets, USP for oral use are available in 5 and 10 mg strengths. Inert ingredients are: anhydrous lactose; colloidal silicon dioxide; magnesium stearate; sodium starch glycolate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "71610-041-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71610-041-60) ",
"NDC11Code": "71610-0041-60",
"ProductNDC": "71610-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hydrochloride",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180214",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat."
},
{
"NDCCode": "72205-041-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72205-041-60) ",
"NDC11Code": "72205-0041-60",
"ProductNDC": "72205-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213220",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200612",
"SamplePackage": "N",
"IndicationAndUsage": "Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.",
"Description": "Dofetilide capsules are an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is:N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]- methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble in 1.0 N sodium hydroxide, acetone, 0.1N hydrochloric acid, very slightly soluble in isopropyl alcohol and insoluble in water. Dofetilide capsules contain the following inactive ingredients: magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose.The capsule shell contains titanium dioxide, FD&C yellow 6 and gelatin, additionally 125 mcg capsule shell contains D&C yellow 10 and FD&C red 40. The printing ink contains shellac, iron oxide black, propylene glycol and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
},
{
"NDCCode": "72789-041-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-041-60) ",
"NDC11Code": "72789-0041-60",
"ProductNDC": "72789-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208507",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191219",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material."
},
{
"NDCCode": "74530-041-01",
"PackageDescription": "3 BOTTLE in 1 PACKAGE (74530-041-01) > 60 mL in 1 BOTTLE",
"NDC11Code": "74530-0041-01",
"ProductNDC": "74530-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "3pk Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200830",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Best Brand Consumers Products, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200830",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease the bacteria on the skin that could cause disease. Recommended for repeated use."
}
]
}
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Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Hypericum Perforatum, Ledum Palustre, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla (pratensis), Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Sulphur, Zincum Metallicum"},{"NDCCode":"49726-047-60","ProprietaryName":"Restulex","NonProprietaryName":"Bufo Rana, Causticum, Chamomilla, Crotalus Horridus, Digitalis Purpurea, Lachesis Mutus, Lilium Tigrinum, Pulsatilla (pratensis) Rhus Tox, Sulphur, Tarentula Hispana, Viscum Album, Zincum Metallicum."},{"NDCCode":"49726-048-60","ProprietaryName":"Synaptol Lactose Free","NonProprietaryName":"Aconitum Ferox, Adrenalinum, Aesculus Hippocastanum, Flos, Apis Mellifica, Argentum Nitricum, Avena Sativa, Baptisia Tinctoria, Cochlearia Armoracia, Phosphorus, Scleranthus Annuus, Flos, Scutellaria Lateriflora, Sumbul, Viola Odorata"},{"NDCCode":"16714-041-02","ProprietaryName":"Allopurinol","NonProprietaryName":"Allopurinol"},{"NDCCode":"16714-041-08","ProprietaryName":"Allopurinol","NonProprietaryName":"Allopurinol"},{"NDCCode":"21130-041-60","ProprietaryName":"Stool Softener Laxative","NonProprietaryName":"Docusate Sodium"},{"NDCCode":"33342-041-98","ProprietaryName":"Sildenafil","NonProprietaryName":"Sildenafil"},{"NDCCode":"42708-041-60","ProprietaryName":"Metoprolol Tartrate","NonProprietaryName":"Metoprolol Tartrate"},{"NDCCode":"43353-041-53","ProprietaryName":"Sodium Bicarbonate","NonProprietaryName":"Sodium Bicarbonate"},{"NDCCode":"43353-041-60","ProprietaryName":"Sodium Bicarbonate","NonProprietaryName":"Sodium Bicarbonate"},{"NDCCode":"46084-041-14","ProprietaryName":"Aphenap","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"59078-041-01","ProprietaryName":"Uv Sunset Waterproof Sun Block","NonProprietaryName":"Zinc Oxide, Titanium Dioxide"},{"NDCCode":"63187-041-60","ProprietaryName":"Diclofenac Sodium","NonProprietaryName":"Diclofenac Sodium"},{"NDCCode":"63379-041-01","ProprietaryName":"Ziagen","NonProprietaryName":"Abacavir Sulfate"},{"NDCCode":"69731-041-24","ProprietaryName":"Safmaxx Hand Sanitizer","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"70005-041-01","ProprietaryName":"Childrens Acetaminophen","NonProprietaryName":"Acetaminophen"},{"NDCCode":"70934-041-60","ProprietaryName":"Minocycline Hydrochloride","NonProprietaryName":"Minocycline Hydrochloride"},{"NDCCode":"71205-041-60","ProprietaryName":"Glipizide","NonProprietaryName":"Glipizide"},{"NDCCode":"71610-041-60","ProprietaryName":"Fexofenadine Hydrochloride","NonProprietaryName":"Fexofenadine Hydrochloride"},{"NDCCode":"72205-041-60","ProprietaryName":"Dofetilide","NonProprietaryName":"Dofetilide"},{"NDCCode":"72789-041-60","ProprietaryName":"Methocarbamol","NonProprietaryName":"Methocarbamol"},{"NDCCode":"74530-041-01","ProprietaryName":"3pk Hand Sanitizer","NonProprietaryName":"Alcohol"}]}
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<PackageDescription>60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (49726-041-60) </PackageDescription>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; EPINEPHRINE; FERULA SUMBUL ROOT; HORSERADISH; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; VIOLA ODORATA</SubstanceName>
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<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of hyperactivity & inattention symptoms including. poor focus. impulsivity. difficulty concentrating when reading or writing. Product indications based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-038-60) </PackageDescription>
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<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ALFALFA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIBASIC POTASSIUM PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HOPS; HYDROCHLORIC ACID; MATRICARIA CHAMOMILLA; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; SILVER NITRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS IGNATII SEED; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
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<Pharm_Classes>Allergens [CS], Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. anxiousness. social fear. panic. hypersensitivity. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-039-60) </PackageDescription>
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<ProprietaryName>Moodbrite</ProprietaryName>
<NonProprietaryName>Anacardium Orientale, Avena Sativa, Aurum Metallicum, Calcarea Carbonica, Carpinus Betulus, Flos, Cimicifuga Racemosa, Cinchona Officinalis, Hypericum Perforatum, Ignatia Amara, Kali Bromatum, Larix Decidua, Flos, Natrum Carbonicum, Natrum Sulphuricum, Phosphoricum Acidum, Phosphorus, Pulsatilla (vulgaris), Sepia, Sinapis Arvensis, Flos, Tabacum</NonProprietaryName>
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<StartMarketingDate>20180416</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ANEMONE PULSATILLA; AVENA SATIVA FLOWERING TOP; BLACK COHOSH; CARPINUS BETULUS FLOWERING TOP; CINCHONA OFFICINALIS BARK; GOLD; HYPERICUM PERFORATUM; LARIX DECIDUA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM BROMIDE; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; TOBACCO LEAF</SubstanceName>
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<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. sadness. loss of interest. poor self-esteem. low motivation. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-040-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-040-60) </PackageDescription>
<NDC11Code>49726-0040-60</NDC11Code>
<ProductNDC>49726-040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Respitrol</ProprietaryName>
<NonProprietaryName>Ammonium Carbonicum, Antimonium Tartaricum, Bromium, Carbo Vegetabilis, Chlorinum, Kali Carbonicum, Lobelia Inflata, Stannum Metallicum, Sulphuricum Acidum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; BROMINE; CHLORINE; LOBELIA INFLATA; POTASSIUM CARBONATE; SULFURIC ACID; TIN</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as: tightness in chest, shortness of breath, cough, or wheezing. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-042-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-042-60) </PackageDescription>
<NDC11Code>49726-0042-60</NDC11Code>
<ProductNDC>49726-042</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Compulsin</ProprietaryName>
<NonProprietaryName>Calcarea Carbonica, Coffea Cruda, Iodium, Mancinella, Physostigma Venenosum, Silicea, Ulmus Procera, Flos</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181015</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE; ULMUS MINOR FLOWERING TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. nervous, repetitive thoughts. disproportionate fears. nervous, repetitive behaviors apprehensiveness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-043-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-043-60) </PackageDescription>
<NDC11Code>49726-0043-60</NDC11Code>
<ProductNDC>49726-043</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Activive</ProprietaryName>
<NonProprietaryName>Alfalfa, Ambra Grisea, Anacardium Orientale, Argentum Nitricum, Aurum Metallicum, Avena Sativa, Caladium Seguinum, Calcarea Carbonica, Cocculus Indicus, Gelsemium Sempervirens, Ignatia Amara, Kali Phosphoricum, Lycopodium Clavatum, Natrum Muriaticum, Nux Moschata, Phosphoricum Acidum, Phosphorus, Selenium Metallicum, Sepia, Silicea, Sulphur</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181019</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ALFALFA; AMBERGRIS; ANAMIRTA COCCULUS SEED; AVENA SATIVA FLOWERING TOP; DIBASIC POTASSIUM PHOSPHATE; DIEFFENBACHIA SEGUINE; GELSEMIUM SEMPERVIRENS ROOT; GOLD; LYCOPODIUM CLAVATUM SPORE; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; SULFUR</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. exhaustion. dullness. drowsiness. muscle weakness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-044-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-044-60) </PackageDescription>
<NDC11Code>49726-0044-60</NDC11Code>
<ProductNDC>49726-044</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neuroveen</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Agaricus Muscarius, Baryta Muriatica, Calendula Officinalis, Carbo Vegetabilis, Carduus Marianus, Chamomilla, Dulcamara, Glonoinum, Hamamelis Virginiana, Lycopersicum Esculentum, Magnesia Phosphorica, Phosphorus, Rhus Tox, Secale Cornutum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181015</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ACTIVATED CHARCOAL; AMANITA MUSCARIA FRUITING BODY; BARIUM CHLORIDE DIHYDRATE; CALENDULA OFFICINALIS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; NITROGLYCERIN; PHOSPHORUS; SILYBUM MARIANUM SEED; SOLANUM DULCAMARA TOP; TOMATO; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vasodilation [PE], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of nerve pain symptoms including: itching numbness swelling burning cramping tingling Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-045-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-045-60) </PackageDescription>
<NDC11Code>49726-0045-60</NDC11Code>
<ProductNDC>49726-045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rhumatol</ProprietaryName>
<NonProprietaryName>Actaea Spicata, Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia (alba), Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Ledum Palustre, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla (pratensis), Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Zincum Metallicumk</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190723</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ACTAEA SPICATA ROOT; ANEMONE PRATENSIS; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HORSE CHESTNUT; HYPERICUM PERFORATUM; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Mood Stabilizer [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. pain. inflammation. stiffness. swelling. weakness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-046-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-046-60) </PackageDescription>
<NDC11Code>49726-0046-60</NDC11Code>
<ProductNDC>49726-046</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Painazol</ProprietaryName>
<NonProprietaryName>Actaea Spicata, Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia (alba), Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Hypericum Perforatum, Ledum Palustre, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla (pratensis), Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Sulphur, Zincum Metallicum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190528</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ACTAEA SPICATA ROOT; ANEMONE PRATENSIS; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HORSE CHESTNUT; HYPERICUM PERFORATUM; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; SULFUR; TOXICODENDRON PUBESCENS LEAF; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Mood Stabilizer [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. pain. burning. weakness. sensitivity. tingling. numbness. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-047-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49726-047-60) </PackageDescription>
<NDC11Code>49726-0047-60</NDC11Code>
<ProductNDC>49726-047</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Restulex</ProprietaryName>
<NonProprietaryName>Bufo Rana, Causticum, Chamomilla, Crotalus Horridus, Digitalis Purpurea, Lachesis Mutus, Lilium Tigrinum, Pulsatilla (pratensis) Rhus Tox, Sulphur, Tarentula Hispana, Viscum Album, Zincum Metallicum.</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191010</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ANEMONE PRATENSIS; BUFO BUFO CUTANEOUS GLAND; CAUSTICUM; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOSA TARANTULA; MATRICARIA CHAMOMILLA; SULFUR; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUIT; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms such as. twitching. burning. heaviness. jerking. cramping. pain. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-048-60</NDCCode>
<PackageDescription>60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (49726-048-60) </PackageDescription>
<NDC11Code>49726-0048-60</NDC11Code>
<ProductNDC>49726-048</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Synaptol Lactose Free</ProprietaryName>
<NonProprietaryName>Aconitum Ferox, Adrenalinum, Aesculus Hippocastanum, Flos, Apis Mellifica, Argentum Nitricum, Avena Sativa, Baptisia Tinctoria, Cochlearia Armoracia, Phosphorus, Scleranthus Annuus, Flos, Scutellaria Lateriflora, Sumbul, Viola Odorata</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220927</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HelloLife, Inc.</LabelerName>
<SubstanceName>ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; EPINEPHRINE; FERULA SUMBUL ROOT; HORSERADISH; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA WHOLE; SILVER NITRATE; VIOLA ODORATA WHOLE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of hyperactivity & inattention symptoms including. poor focus. impulsivity. fidgeting. difficulty concentrating when reading or writing. Product indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-041-02</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16714-041-02)</PackageDescription>
<NDC11Code>16714-0041-02</NDC11Code>
<ProductNDC>16714-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078253</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>16714-041-08</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16714-041-08)</PackageDescription>
<NDC11Code>16714-0041-08</NDC11Code>
<ProductNDC>16714-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078253</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>21130-041-60</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (21130-041-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>21130-0041-60</NDC11Code>
<ProductNDC>21130-041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener Laxative</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210131</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Safeway, Inc.</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity) . generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33342-041-98</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (33342-041-98) / 60 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0041-98</NDC11Code>
<ProductNDC>33342-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202255</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil Tablets, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3 d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4 methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets, USP are formulated as white to off-white, diamond shaped film-coated tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate and microcrystalline cellulose. The film coating ingredient contains: Hypromellose, titanium dioxide, triacetin.</Description>
</NDC>
<NDC>
<NDCCode>42708-041-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42708-041-60) </PackageDescription>
<NDC11Code>42708-0041-60</NDC11Code>
<ProductNDC>42708-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077739</ApplicationNumber>
<LabelerName>QPharma Inc</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180330</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>43353-041-53</NDCCode>
<PackageDescription>60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-53)</PackageDescription>
<NDC11Code>43353-0041-53</NDC11Code>
<ProductNDC>43353-041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120626</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43353-041-60</NDCCode>
<PackageDescription>90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-60)</PackageDescription>
<NDC11Code>43353-0041-60</NDC11Code>
<ProductNDC>43353-041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120626</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>46084-041-14</NDCCode>
<PackageDescription>60 TABLET in 1 BLISTER PACK (46084-041-14)</PackageDescription>
<NDC11Code>46084-0041-14</NDC11Code>
<ProductNDC>46084-041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aphenap</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>A P J Laboratories Limited</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59078-041-01</NDCCode>
<PackageDescription>60 g in 1 CARTON (59078-041-01)</PackageDescription>
<NDC11Code>59078-0041-01</NDC11Code>
<ProductNDC>59078-041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uv Sunset Waterproof Sun Block</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>TONYMOLY CO., LTD.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>8.06; 2.1</StrengthNumber>
<StrengthUnit>g/60g; g/60g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63187-041-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-041-60) </PackageDescription>
<NDC11Code>63187-0041-60</NDC11Code>
<ProductNDC>63187-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960308</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA020254</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63379-041-01</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (63379-041-01) </PackageDescription>
<NDC11Code>63379-0041-01</NDC11Code>
<ProductNDC>63379-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziagen</ProprietaryName>
<NonProprietaryName>Abacavir Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981229</StartMarketingDate>
<MarketingCategoryName>APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
<ApplicationNumber>NDA020977</ApplicationNumber>
<LabelerName>Glaxo Operations UK Ltd</LabelerName>
<SubstanceName>ABACAVIR SULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69731-041-24</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (69731-041-24) </PackageDescription>
<NDC11Code>69731-0041-24</NDC11Code>
<ProductNDC>69731-041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Safmaxx Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>G&N Enterprise,LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 handwash to help reduce bacteria that potentially can cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70005-041-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (70005-041-01) > 60 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>70005-0041-01</NDC11Code>
<ProductNDC>70005-041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160817</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>We Care Distributors Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily reduces fever. temporarily relieves minor aches and pains due to:. the common cold . flu . headache . sore throat . toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70934-041-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (70934-041-60) </PackageDescription>
<NDC11Code>70934-0041-60</NDC11Code>
<ProductNDC>70934-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065062</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-041-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71205-041-60) </PackageDescription>
<NDC11Code>71205-0041-60</NDC11Code>
<ProductNDC>71205-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075795</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets, USP for oral use are available in 5 and 10 mg strengths. Inert ingredients are: anhydrous lactose; colloidal silicon dioxide; magnesium stearate; sodium starch glycolate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71610-041-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71610-041-60) </PackageDescription>
<NDC11Code>71610-0041-60</NDC11Code>
<ProductNDC>71610-041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72205-041-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (72205-041-60) </PackageDescription>
<NDC11Code>72205-0041-60</NDC11Code>
<ProductNDC>72205-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213220</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.</IndicationAndUsage>
<Description>Dofetilide capsules are an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is:N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]- methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble in 1.0 N sodium hydroxide, acetone, 0.1N hydrochloric acid, very slightly soluble in isopropyl alcohol and insoluble in water. Dofetilide capsules contain the following inactive ingredients: magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose.The capsule shell contains titanium dioxide, FD&C yellow 6 and gelatin, additionally 125 mcg capsule shell contains D&C yellow 10 and FD&C red 40. The printing ink contains shellac, iron oxide black, propylene glycol and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
</NDC>
<NDC>
<NDCCode>72789-041-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-041-60) </PackageDescription>
<NDC11Code>72789-0041-60</NDC11Code>
<ProductNDC>72789-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208507</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material.</Description>
</NDC>
<NDC>
<NDCCode>74530-041-01</NDCCode>
<PackageDescription>3 BOTTLE in 1 PACKAGE (74530-041-01) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>74530-0041-01</NDC11Code>
<ProductNDC>74530-041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>3pk Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200830</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Best Brand Consumers Products, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease the bacteria on the skin that could cause disease. Recommended for repeated use.</IndicationAndUsage>
</NDC>
</NDCList>