{
"NDC": [
{
"NDCCode": "55714-4418-1",
"PackageDescription": "29.57 mL in 1 BOTTLE, GLASS (55714-4418-1)",
"NDC11Code": "55714-4418-01",
"ProductNDC": "55714-4418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sinusitis",
"NonProprietaryName": "Arsenicum Iodatum, Bryonia, Cistus Canadensis, Hepar Sulph. Calc., Histaminum Hydrochloricum, Hydrastis, Iodium, Kali Bic., Kali Iod., Merc. Iod. Rub., Merc. Viv., Nux Vom., Phosphorus, Pulsatilla, Sabadilla, Sticta, Verbascum, Echinacea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; HELIANTHEMUM CANADENSE; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; IODINE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; MERCURIC IODIDE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Sinusitis Formulated for symptoms of acute or chronic sinusitis associated with allergies and bacterial or fungal infections."
},
{
"NDCCode": "55714-4418-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-4418-2)",
"NDC11Code": "55714-4418-02",
"ProductNDC": "55714-4418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sinusitis",
"NonProprietaryName": "Arsenicum Iodatum, Bryonia, Cistus Canadensis, Hepar Sulph. Calc., Histaminum Hydrochloricum, Hydrastis, Iodium, Kali Bic., Kali Iod., Merc. Iod. Rub., Merc. Viv., Nux Vom., Phosphorus, Pulsatilla, Sabadilla, Sticta, Verbascum, Echinacea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; HELIANTHEMUM CANADENSE; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; IODINE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; MERCURIC IODIDE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Sinusitis Formulated for symptoms of acute or chronic sinusitis associated with allergies and bacterial or fungal infections."
},
{
"NDCCode": "22840-4418-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-4418-2) ",
"NDC11Code": "22840-4418-02",
"ProductNDC": "22840-4418",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Water Oak Pollen",
"NonProprietaryName": "Quercus Nigra",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "QUERCUS NIGRA POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "22840-4418-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-4418-4) ",
"NDC11Code": "22840-4418-04",
"ProductNDC": "22840-4418",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Water Oak Pollen",
"NonProprietaryName": "Quercus Nigra",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "QUERCUS NIGRA POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "57293-4418-2",
"PackageDescription": "60 mL in 1 BOTTLE, GLASS (57293-4418-2) ",
"NDC11Code": "57293-4418-02",
"ProductNDC": "57293-4418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Yeast And Fungi",
"NonProprietaryName": "Arsenic Trioxide, Bryonia Alba Root, Calendula Officinalis Flowering Top, Candida Albicans, Graphite, Calcium Sulfide, Lycopodium Clavatum Spore, Mercurius Solubilis, Viscum Album Fruiting Top",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920310",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "BioEnergetics, Inc.",
"SubstanceName": "ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CANDIDA ALBICANS; GRAPHITE; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "12; 6; 4; 30; 12; 12; 30; 12; 6",
"StrengthUnit": "[hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19920310",
"SamplePackage": "N"
},
{
"NDCCode": "62670-4418-0",
"PackageDescription": "29 mL in 1 BOTTLE (62670-4418-0)",
"NDC11Code": "62670-4418-00",
"ProductNDC": "62670-4418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Cheer Holiday Berries",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2014-04-07"
},
{
"NDCCode": "68071-4418-2",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (68071-4418-2) ",
"NDC11Code": "68071-4418-02",
"ProductNDC": "68071-4418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065228",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "875",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180507",
"SamplePackage": "N"
},
{
"NDCCode": "70518-4418-0",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70518-4418-0) ",
"NDC11Code": "70518-4418-00",
"ProductNDC": "70518-4418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202871",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: 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) Angina Pectoris. ( 1.2) 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, USP a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)tartrate (2:1) 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. Inactive Ingredients:microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents."
},
{
"NDCCode": "70518-4418-1",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (70518-4418-1) ",
"NDC11Code": "70518-4418-01",
"ProductNDC": "70518-4418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202871",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250825",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: 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) Angina Pectoris. ( 1.2) 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, USP a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)tartrate (2:1) 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. Inactive Ingredients:microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents."
},
{
"NDCCode": "70518-4418-2",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70518-4418-2) ",
"NDC11Code": "70518-4418-02",
"ProductNDC": "70518-4418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202871",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250911",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: 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) Angina Pectoris. ( 1.2) 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, USP a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)tartrate (2:1) 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. Inactive Ingredients:microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents."
},
{
"NDCCode": "70518-4418-3",
"PackageDescription": "50 POUCH in 1 BOX (70518-4418-3) / 1 TABLET in 1 POUCH (70518-4418-4) ",
"NDC11Code": "70518-4418-03",
"ProductNDC": "70518-4418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202871",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260623",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: 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) Angina Pectoris. ( 1.2) 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, USP a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)tartrate (2:1) 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. Inactive Ingredients:microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents."
},
{
"NDCCode": "70518-4418-5",
"PackageDescription": "180 TABLET in 1 BOTTLE, PLASTIC (70518-4418-5) ",
"NDC11Code": "70518-4418-05",
"ProductNDC": "70518-4418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202871",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260623",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: 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) Angina Pectoris. ( 1.2) 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, USP a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)tartrate (2:1) 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. Inactive Ingredients:microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents."
},
{
"NDCCode": "55714-1101-1",
"PackageDescription": "29.57 mL in 1 BOTTLE, GLASS (55714-1101-1)",
"NDC11Code": "55714-1101-01",
"ProductNDC": "55714-1101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prime Plus",
"NonProprietaryName": "Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo, Ruta, Organic, Cane Dispensing Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO; RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55714-1101-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1101-2)",
"NDC11Code": "55714-1101-02",
"ProductNDC": "55714-1101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prime Plus",
"NonProprietaryName": "Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo, Ruta, Organic, Cane Dispensing Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO; RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55714-1102-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1102-0)",
"NDC11Code": "55714-1102-00",
"ProductNDC": "55714-1102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sick Stopper",
"NonProprietaryName": "Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS",
"StrengthNumber": "30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms."
},
{
"NDCCode": "55714-1102-1",
"PackageDescription": "29.57 mL in 1 BOTTLE, GLASS (55714-1102-1)",
"NDC11Code": "55714-1102-01",
"ProductNDC": "55714-1102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sick Stopper",
"NonProprietaryName": "Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS",
"StrengthNumber": "30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms."
},
{
"NDCCode": "55714-1102-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1102-2)",
"NDC11Code": "55714-1102-02",
"ProductNDC": "55714-1102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sick Stopper",
"NonProprietaryName": "Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS",
"StrengthNumber": "30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms."
},
{
"NDCCode": "55714-1103-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1103-0)",
"NDC11Code": "55714-1103-00",
"ProductNDC": "55714-1103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Swimmers Support",
"NonProprietaryName": "Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM",
"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]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness."
},
{
"NDCCode": "55714-1103-1",
"PackageDescription": "29.57 mL in 1 BOTTLE, GLASS (55714-1103-1)",
"NDC11Code": "55714-1103-01",
"ProductNDC": "55714-1103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Swimmers Support",
"NonProprietaryName": "Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM",
"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]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness."
},
{
"NDCCode": "55714-1103-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1103-2)",
"NDC11Code": "55714-1103-02",
"ProductNDC": "55714-1103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Swimmers Support",
"NonProprietaryName": "Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM",
"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]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness."
},
{
"NDCCode": "55714-1104-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1104-0)",
"NDC11Code": "55714-1104-00",
"ProductNDC": "55714-1104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hangover Help",
"NonProprietaryName": "Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache."
},
{
"NDCCode": "55714-1104-1",
"PackageDescription": "29.57 mL in 1 BOTTLE, GLASS (55714-1104-1)",
"NDC11Code": "55714-1104-01",
"ProductNDC": "55714-1104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hangover Help",
"NonProprietaryName": "Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache."
},
{
"NDCCode": "55714-1104-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1104-2)",
"NDC11Code": "55714-1104-02",
"ProductNDC": "55714-1104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hangover Help",
"NonProprietaryName": "Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache."
},
{
"NDCCode": "55714-1105-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1105-0)",
"NDC11Code": "55714-1105-00",
"ProductNDC": "55714-1105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prime Plus",
"NonProprietaryName": "Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Prime+ Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin."
},
{
"NDCCode": "55714-1105-1",
"PackageDescription": "28.35 g in 1 BOTTLE, GLASS (55714-1105-1)",
"NDC11Code": "55714-1105-01",
"ProductNDC": "55714-1105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prime Plus",
"NonProprietaryName": "Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Prime+ Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin."
},
{
"NDCCode": "55714-1105-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-1105-2)",
"NDC11Code": "55714-1105-02",
"ProductNDC": "55714-1105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prime Plus",
"NonProprietaryName": "Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Prime+ Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin."
},
{
"NDCCode": "55714-1106-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1106-0)",
"NDC11Code": "55714-1106-00",
"ProductNDC": "55714-1106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panic Button",
"NonProprietaryName": "Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-1106-1",
"PackageDescription": "29.57 mL in 1 BOTTLE, GLASS (55714-1106-1)",
"NDC11Code": "55714-1106-01",
"ProductNDC": "55714-1106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panic Button",
"NonProprietaryName": "Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-1106-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1106-2)",
"NDC11Code": "55714-1106-02",
"ProductNDC": "55714-1106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panic Button",
"NonProprietaryName": "Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-1107-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1107-0)",
"NDC11Code": "55714-1107-00",
"ProductNDC": "55714-1107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sports Injury",
"NonProprietaryName": "Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2017-10-13"
}
]
}
{"NDC":[{"NDCCode":"55714-4418-1","ProprietaryName":"Sinusitis","NonProprietaryName":"Arsenicum Iodatum, Bryonia, Cistus Canadensis, Hepar Sulph. Calc., Histaminum Hydrochloricum, Hydrastis, Iodium, Kali Bic., Kali Iod., Merc. Iod. Rub., Merc. Viv., Nux Vom., Phosphorus, Pulsatilla, Sabadilla, Sticta, Verbascum, Echinacea"},{"NDCCode":"55714-4418-2","ProprietaryName":"Sinusitis","NonProprietaryName":"Arsenicum Iodatum, Bryonia, Cistus Canadensis, Hepar Sulph. Calc., Histaminum Hydrochloricum, Hydrastis, Iodium, Kali Bic., Kali Iod., Merc. Iod. Rub., Merc. Viv., Nux Vom., Phosphorus, Pulsatilla, Sabadilla, Sticta, Verbascum, Echinacea"},{"NDCCode":"22840-4418-2","ProprietaryName":"Water Oak Pollen","NonProprietaryName":"Quercus Nigra"},{"NDCCode":"22840-4418-4","ProprietaryName":"Water Oak Pollen","NonProprietaryName":"Quercus Nigra"},{"NDCCode":"57293-4418-2","ProprietaryName":"Yeast And Fungi","NonProprietaryName":"Arsenic Trioxide, Bryonia Alba Root, Calendula Officinalis Flowering Top, Candida Albicans, Graphite, Calcium Sulfide, Lycopodium Clavatum Spore, Mercurius Solubilis, Viscum Album Fruiting Top"},{"NDCCode":"62670-4418-0","ProprietaryName":"Anti-bacterial Hand","NonProprietaryName":"Alcohol"},{"NDCCode":"68071-4418-2","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"70518-4418-0","ProprietaryName":"Metoprolol Tartrate","NonProprietaryName":"Metoprolol"},{"NDCCode":"70518-4418-1","ProprietaryName":"Metoprolol Tartrate","NonProprietaryName":"Metoprolol"},{"NDCCode":"70518-4418-2","ProprietaryName":"Metoprolol Tartrate","NonProprietaryName":"Metoprolol"},{"NDCCode":"70518-4418-3","ProprietaryName":"Metoprolol Tartrate","NonProprietaryName":"Metoprolol"},{"NDCCode":"70518-4418-5","ProprietaryName":"Metoprolol Tartrate","NonProprietaryName":"Metoprolol"},{"NDCCode":"55714-1101-1","ProprietaryName":"Prime Plus","NonProprietaryName":"Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo, Ruta, Organic, Cane Dispensing Alcohol"},{"NDCCode":"55714-1101-2","ProprietaryName":"Prime Plus","NonProprietaryName":"Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo, Ruta, Organic, Cane Dispensing Alcohol"},{"NDCCode":"55714-1102-0","ProprietaryName":"Sick Stopper","NonProprietaryName":"Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. 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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDate>19920310</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>BioEnergetics, Inc.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CANDIDA ALBICANS; GRAPHITE; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>12; 6; 4; 30; 12; 12; 30; 12; 6</StrengthNumber>
<StrengthUnit>[hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>62670-4418-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-4418-0)</PackageDescription>
<NDC11Code>62670-4418-00</NDC11Code>
<ProductNDC>62670-4418</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Cheer Holiday Berries</ProprietaryNameSuffix>
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<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-04-07</LastUpdate>
</NDC>
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<NDCCode>68071-4418-2</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (68071-4418-2) </PackageDescription>
<NDC11Code>68071-4418-02</NDC11Code>
<ProductNDC>68071-4418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065228</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>875</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70518-4418-0</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (70518-4418-0) </PackageDescription>
<NDC11Code>70518-4418-00</NDC11Code>
<ProductNDC>70518-4418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202871</ApplicationNumber>
<LabelerName>REMEDYREPACK 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>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: 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) Angina Pectoris. ( 1.2) 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, USP a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)tartrate (2:1) 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. Inactive Ingredients:microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents.</Description>
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<IndicationAndUsage>Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: 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) Angina Pectoris. ( 1.2) 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, USP a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)tartrate (2:1) 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. Inactive Ingredients:microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents.</Description>
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<IndicationAndUsage>Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: 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) Angina Pectoris. ( 1.2) 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, USP a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)tartrate (2:1) 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. Inactive Ingredients:microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: 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) Angina Pectoris. ( 1.2) 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, USP a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)tartrate (2:1) 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. Inactive Ingredients:microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents.</Description>
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<NDCCode>70518-4418-5</NDCCode>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>REMEDYREPACK INC.</LabelerName>
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<StrengthNumber>50</StrengthNumber>
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<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablet is a beta-adrenergic blocker indicated for the treatment of: 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) Angina Pectoris. ( 1.2) 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, USP a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate, USP is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)tartrate (2:1) 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. Inactive Ingredients:microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>55714-1101-1</NDCCode>
<PackageDescription>29.57 mL in 1 BOTTLE, GLASS (55714-1101-1)</PackageDescription>
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<ProprietaryName>Prime Plus</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO; RUTA GRAVEOLENS FLOWERING TOP</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-1101-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1101-2)</PackageDescription>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
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<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-1102-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1102-0)</PackageDescription>
<NDC11Code>55714-1102-00</NDC11Code>
<ProductNDC>55714-1102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sick Stopper</ProprietaryName>
<NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea</NonProprietaryName>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS</SubstanceName>
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<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>29.57 mL in 1 BOTTLE, GLASS (55714-1102-1)</PackageDescription>
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<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1102-2)</PackageDescription>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1103-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1103-0)</PackageDescription>
<NDC11Code>55714-1103-00</NDC11Code>
<ProductNDC>55714-1103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Swimmers Support</ProprietaryName>
<NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM</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]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1103-1</NDCCode>
<PackageDescription>29.57 mL in 1 BOTTLE, GLASS (55714-1103-1)</PackageDescription>
<NDC11Code>55714-1103-01</NDC11Code>
<ProductNDC>55714-1103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Swimmers Support</ProprietaryName>
<NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM</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]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1103-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1103-2)</PackageDescription>
<NDC11Code>55714-1103-02</NDC11Code>
<ProductNDC>55714-1103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Swimmers Support</ProprietaryName>
<NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM</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]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1104-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1104-0)</PackageDescription>
<NDC11Code>55714-1104-00</NDC11Code>
<ProductNDC>55714-1104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hangover Help</ProprietaryName>
<NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1104-1</NDCCode>
<PackageDescription>29.57 mL in 1 BOTTLE, GLASS (55714-1104-1)</PackageDescription>
<NDC11Code>55714-1104-01</NDC11Code>
<ProductNDC>55714-1104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hangover Help</ProprietaryName>
<NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1104-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1104-2)</PackageDescription>
<NDC11Code>55714-1104-02</NDC11Code>
<ProductNDC>55714-1104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hangover Help</ProprietaryName>
<NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1105-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1105-0)</PackageDescription>
<NDC11Code>55714-1105-00</NDC11Code>
<ProductNDC>55714-1105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prime Plus</ProprietaryName>
<NonProprietaryName>Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prime+ Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1105-1</NDCCode>
<PackageDescription>28.35 g in 1 BOTTLE, GLASS (55714-1105-1)</PackageDescription>
<NDC11Code>55714-1105-01</NDC11Code>
<ProductNDC>55714-1105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prime Plus</ProprietaryName>
<NonProprietaryName>Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prime+ Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1105-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-1105-2)</PackageDescription>
<NDC11Code>55714-1105-02</NDC11Code>
<ProductNDC>55714-1105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prime Plus</ProprietaryName>
<NonProprietaryName>Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prime+ Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1106-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1106-0)</PackageDescription>
<NDC11Code>55714-1106-00</NDC11Code>
<ProductNDC>55714-1106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Panic Button</ProprietaryName>
<NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-1106-1</NDCCode>
<PackageDescription>29.57 mL in 1 BOTTLE, GLASS (55714-1106-1)</PackageDescription>
<NDC11Code>55714-1106-01</NDC11Code>
<ProductNDC>55714-1106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Panic Button</ProprietaryName>
<NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-1106-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1106-2)</PackageDescription>
<NDC11Code>55714-1106-02</NDC11Code>
<ProductNDC>55714-1106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Panic Button</ProprietaryName>
<NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-1107-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1107-0)</PackageDescription>
<NDC11Code>55714-1107-00</NDC11Code>
<ProductNDC>55714-1107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sports Injury</ProprietaryName>
<NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-13</LastUpdate>
</NDC>
</NDCList>
<NDCList><NDC><NDCCode>55714-4418-1</NDCCode><ProprietaryName>Sinusitis</ProprietaryName><NonProprietaryName>Arsenicum Iodatum, Bryonia, Cistus Canadensis, Hepar Sulph. Calc., Histaminum Hydrochloricum, Hydrastis, Iodium, Kali Bic., Kali Iod., Merc. Iod. Rub., Merc. Viv., Nux Vom., Phosphorus, Pulsatilla, Sabadilla, Sticta, Verbascum, Echinacea</NonProprietaryName></NDC><NDC><NDCCode>55714-4418-2</NDCCode><ProprietaryName>Sinusitis</ProprietaryName><NonProprietaryName>Arsenicum Iodatum, Bryonia, Cistus Canadensis, Hepar Sulph. Calc., Histaminum Hydrochloricum, Hydrastis, Iodium, Kali Bic., Kali Iod., Merc. Iod. Rub., Merc. Viv., Nux Vom., Phosphorus, Pulsatilla, Sabadilla, Sticta, Verbascum, Echinacea</NonProprietaryName></NDC><NDC><NDCCode>22840-4418-2</NDCCode><ProprietaryName>Water Oak Pollen</ProprietaryName><NonProprietaryName>Quercus Nigra</NonProprietaryName></NDC><NDC><NDCCode>22840-4418-4</NDCCode><ProprietaryName>Water Oak Pollen</ProprietaryName><NonProprietaryName>Quercus Nigra</NonProprietaryName></NDC><NDC><NDCCode>57293-4418-2</NDCCode><ProprietaryName>Yeast And Fungi</ProprietaryName><NonProprietaryName>Arsenic Trioxide, Bryonia Alba Root, Calendula Officinalis Flowering Top, Candida Albicans, Graphite, Calcium Sulfide, Lycopodium Clavatum Spore, Mercurius Solubilis, Viscum Album Fruiting Top</NonProprietaryName></NDC><NDC><NDCCode>62670-4418-0</NDCCode><ProprietaryName>Anti-bacterial Hand</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>68071-4418-2</NDCCode><ProprietaryName>Amoxicillin</ProprietaryName><NonProprietaryName>Amoxicillin</NonProprietaryName></NDC><NDC><NDCCode>70518-4418-0</NDCCode><ProprietaryName>Metoprolol Tartrate</ProprietaryName><NonProprietaryName>Metoprolol</NonProprietaryName></NDC><NDC><NDCCode>70518-4418-1</NDCCode><ProprietaryName>Metoprolol Tartrate</ProprietaryName><NonProprietaryName>Metoprolol</NonProprietaryName></NDC><NDC><NDCCode>70518-4418-2</NDCCode><ProprietaryName>Metoprolol Tartrate</ProprietaryName><NonProprietaryName>Metoprolol</NonProprietaryName></NDC><NDC><NDCCode>70518-4418-3</NDCCode><ProprietaryName>Metoprolol Tartrate</ProprietaryName><NonProprietaryName>Metoprolol</NonProprietaryName></NDC><NDC><NDCCode>70518-4418-5</NDCCode><ProprietaryName>Metoprolol Tartrate</ProprietaryName><NonProprietaryName>Metoprolol</NonProprietaryName></NDC><NDC><NDCCode>55714-1101-1</NDCCode><ProprietaryName>Prime Plus</ProprietaryName><NonProprietaryName>Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo, Ruta, Organic, Cane Dispensing Alcohol</NonProprietaryName></NDC><NDC><NDCCode>55714-1101-2</NDCCode><ProprietaryName>Prime Plus</ProprietaryName><NonProprietaryName>Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo, Ruta, Organic, Cane Dispensing Alcohol</NonProprietaryName></NDC><NDC><NDCCode>55714-1102-0</NDCCode><ProprietaryName>Sick Stopper</ProprietaryName><NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea</NonProprietaryName></NDC><NDC><NDCCode>55714-1102-1</NDCCode><ProprietaryName>Sick Stopper</ProprietaryName><NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea</NonProprietaryName></NDC><NDC><NDCCode>55714-1102-2</NDCCode><ProprietaryName>Sick Stopper</ProprietaryName><NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea</NonProprietaryName></NDC><NDC><NDCCode>55714-1103-0</NDCCode><ProprietaryName>Swimmers Support</ProprietaryName><NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName></NDC><NDC><NDCCode>55714-1103-1</NDCCode><ProprietaryName>Swimmers Support</ProprietaryName><NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName></NDC><NDC><NDCCode>55714-1103-2</NDCCode><ProprietaryName>Swimmers Support</ProprietaryName><NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName></NDC><NDC><NDCCode>55714-1104-0</NDCCode><ProprietaryName>Hangover Help</ProprietaryName><NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName></NDC><NDC><NDCCode>55714-1104-1</NDCCode><ProprietaryName>Hangover Help</ProprietaryName><NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName></NDC><NDC><NDCCode>55714-1104-2</NDCCode><ProprietaryName>Hangover Help</ProprietaryName><NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName></NDC><NDC><NDCCode>55714-1105-0</NDCCode><ProprietaryName>Prime Plus</ProprietaryName><NonProprietaryName>Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo</NonProprietaryName></NDC><NDC><NDCCode>55714-1105-1</NDCCode><ProprietaryName>Prime Plus</ProprietaryName><NonProprietaryName>Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo</NonProprietaryName></NDC><NDC><NDCCode>55714-1105-2</NDCCode><ProprietaryName>Prime Plus</ProprietaryName><NonProprietaryName>Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo</NonProprietaryName></NDC><NDC><NDCCode>55714-1106-0</NDCCode><ProprietaryName>Panic Button</ProprietaryName><NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.</NonProprietaryName></NDC><NDC><NDCCode>55714-1106-1</NDCCode><ProprietaryName>Panic Button</ProprietaryName><NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.</NonProprietaryName></NDC><NDC><NDCCode>55714-1106-2</NDCCode><ProprietaryName>Panic Button</ProprietaryName><NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.</NonProprietaryName></NDC><NDC><NDCCode>55714-1107-0</NDCCode><ProprietaryName>Sports Injury</ProprietaryName><NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName></NDC></NDCList>