{
"NDC": [
{
"NDCCode": "71971-6030-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-6030-8) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "71971-6030-08",
"ProductNDC": "71971-6030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Allium Cepa, Aralia Racemosa, Arsenicum Album, Cuprum Metallicum, Euphrasia Officinalis, Nux Vomica, Sabadilla, Sticta Pulmonaria",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "ONION; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; COPPER; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic remedy to relieve from symptoms of all allergies: 1 Nasal congestion, 2 Sneezing, 3 Runny nose, 4 Itchy, watery eyes."
},
{
"NDCCode": "71971-6030-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-6030-0) > 90 TABLET in 1 BOTTLE",
"NDC11Code": "71971-6030-00",
"ProductNDC": "71971-6030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Allium Cepa, Aralia Racemosa, Arsenicum Album, Cuprum Metallicum, Euphrasia Officinalis, Nux Vomica, Sabadilla, Sticta Pulmonaria",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "ONION; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; COPPER; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic remedy to relieve from symptoms of all allergies: 1 Nasal congestion, 2 Sneezing, 3 Runny nose, 4 Itchy, watery eyes."
},
{
"NDCCode": "71971-6030-5",
"PackageDescription": "30 TABLET in 1 BOTTLE (71971-6030-5) ",
"NDC11Code": "71971-6030-05",
"ProductNDC": "71971-6030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Allium Cepa, Aralia Racemosa, Arsenicum Album, Cuprum Metallicum, Euphrasia Officinalis, Nux Vomica, Sabadilla, Sticta Pulmonaria",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "ONION; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; COPPER; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic remedy to relieve from symptoms of all allergies: 1 Nasal congestion, 2 Sneezing, 3 Runny nose, 4 Itchy, watery eyes."
},
{
"NDCCode": "71971-6001-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-6001-8) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "71971-6001-08",
"ProductNDC": "71971-6001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Eriodictyon Californicum, Histaminum, Ipecacuanha, Lobelia Inflata, Sambucus Nigra, Solidago Virgaurea",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma: 1 gasping for air, 2 difficulty breathing, 3 wheezing, 4 coughing, 5 excess mucus."
},
{
"NDCCode": "71971-6002-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-6002-8) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "71971-6002-08",
"ProductNDC": "71971-6002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Chamomila, Coffea Cruda, Eriodictyon Californicum, Histaminum, Ipecacuanha, Lobelia Inflata, Sambucus Nigra, Solidago Virgaurea",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "MATRICARIA CHAMOMILLA; ARABICA COFFEE BEAN; ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma: 1 gasping for air, 2 difficulty breathing, 3 wheezing, 4 coughing, 5 excess mucus."
},
{
"NDCCode": "71971-6032-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-6032-8) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "71971-6032-08",
"ProductNDC": "71971-6032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Arnica Montana, Bryonia, Causticum, Cinchona Officinalis, Dulcamara, Hydrastis Canadensis, Kali Bromatum, Sulphur",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; GOLDENSEAL; POTASSIUM BROMIDE; SULFUR",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated: 1 with tinnitus, 2 Rigging and buzzing in the ears, 3 Ear pain & pressure, 4 Headache."
},
{
"NDCCode": "71971-6036-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-6036-8) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "71971-6036-08",
"ProductNDC": "71971-6036",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Apis Mellifica, Arnica Montana, Benzoicum Acidum, Causticum, Colchicum Autumnale, Natrum Carbonicum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "APIS MELLIFERA; ARNICA MONTANA; BENZOIC ACID; CAUSTICUM; COLCHICUM AUTUMNALE BULB; SODIUM CARBONATE",
"StrengthNumber": "8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Ammonium Ion Binding Activity [MoA], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated: 1 with arthritis, 2 joint pain, 3 stiffness, 4 inflammation, 5 soreness."
},
{
"NDCCode": "71971-9060-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-9060-8) > 25 mL in 1 BOTTLE",
"NDC11Code": "71971-9060-08",
"ProductNDC": "71971-9060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"ProprietaryNameSuffix": "Teething Oral Liquid",
"NonProprietaryName": "Chamomilla, Arnica Montana, Borax, Hypericum Perforatum Liquid",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "MATRICARIA RECUTITA; ARNICA MONTANA; SODIUM BORATE; HYPERICUM PERFORATUM",
"StrengthNumber": "5; 5; 5; 5",
"StrengthUnit": "[hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL",
"Status": "Active",
"LastUpdate": "2019-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by teething*. gum inflammation. gum pain. fever. diarrhea. restlessness and irritability."
},
{
"NDCCode": "71971-9062-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-9062-8) > 25 mL in 1 BOTTLE",
"NDC11Code": "71971-9062-08",
"ProductNDC": "71971-9062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Anas Barbariae Hepatis Et Cordis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/25mL",
"Status": "Active",
"LastUpdate": "2019-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made form an ingredient. traditionally used to temporarily help relieve flu-like symptoms*. fever aches pains chills feeling run-down."
},
{
"NDCCode": "71971-9066-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-9066-8) > 25 mL in 1 BOTTLE",
"NDC11Code": "71971-9066-08",
"ProductNDC": "71971-9066",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Pulsatilla, Allium Cepa, Arsenicum Album, Nux Vomica, Euphrasia Offinalis, Sabadilla, Aralia Racemosa, Cuprum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190726",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "ANEMONE PULSATILLA; ONION; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED; ARALIA RACEMOSA ROOT; COPPER",
"StrengthNumber": "8; 6; 8; 6; 6; 6; 6; 8",
"StrengthUnit": "[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2019-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190726",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by sinus symptoms*. sneezing nasal congestion runny nose itchy eyes, nose and throat watery eyes headache throat irritation."
},
{
"NDCCode": "71971-9077-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-9077-8) > 25 mL in 1 BOTTLE",
"NDC11Code": "71971-9077-08",
"ProductNDC": "71971-9077",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Pulsatilla, Allium Cepa, Arsenicum Album, Nux Vomica, Euphrasia Offinalis, Sabadilla, Sticta Pulmonaria, Araila Racemosa, Cuprum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "ANEMONE PULSATILLA; ONION; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; ARALIA RACEMOSA ROOT; COPPER",
"StrengthNumber": "8; 6; 8; 6; 6; 6; 6; 6; 8",
"StrengthUnit": "[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2019-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of. ingredients traditionally used to help relieve allergy symptoms*. sneezing nasal congestion. throat and skin irritation teary eyes."
},
{
"NDCCode": "71971-9083-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-9083-8) > 25 mL in 1 BOTTLE",
"NDC11Code": "71971-9083-08",
"ProductNDC": "71971-9083",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Colocynthis, Magnesia Phosphorica, Chamomilla, Dioscorea Villosa",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA; DIOSCOREA VILLOSA TUBER",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2019-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of. ingredients traditionally used to help relieve symptoms. associated with colic* intestinal gas abdominal pain. bloating nausea burping."
},
{
"NDCCode": "71971-9214-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-9214-8) > 25 mL in 1 BOTTLE",
"NDC11Code": "71971-9214-08",
"ProductNDC": "71971-9214",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Ferrum Phosphoricum, Capsicum Annuum, Pyrogenium, Arsenicum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "FERRUM PHOSPHORICUM; CAPSICUM; RANCID BEEF; ARSENIC TRIOXIDE",
"StrengthNumber": "30; 30; 30; 30",
"StrengthUnit": "[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2019-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This oral homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve* the sensa-. tion of fullness of the ear, sensitivity to water and drafts, and. the annoyance of water-clogged ears by helping clear water. trapped in the ear."
},
{
"NDCCode": "71971-9216-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-9216-8) > 25 mL in 1 BOTTLE",
"NDC11Code": "71971-9216-08",
"ProductNDC": "71971-9216",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Arnica Montana, Ferrum Phosphoricum, Hypericum Perforatum, Thuja Occidentalis, Ledum Palustre",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "ARNICA MONTANA; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; THUJA OCCIDENTALIS LEAFY TWIG; RHODODENDRON TOMENTOSUM LEAFY TWIG",
"StrengthNumber": "8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL",
"Status": "Active",
"LastUpdate": "2019-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of. ingredients traditionally used to help temporarily reduce. fever and relieve minor aches and pains associated with. common cold headache. sore throat toothache."
},
{
"NDCCode": "23731-6030-1",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CASE (23731-6030-1) / 30 mL in 1 VIAL, SINGLE-USE (23731-6030-3) ",
"NDC11Code": "23731-6030-01",
"ProductNDC": "23731-6030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tricitrasol",
"NonProprietaryName": "Trisodium Citrate Dihydrate",
"DosageFormName": "SOLUTION",
"RouteName": "EXTRACORPOREAL",
"StartMarketingDate": "20030710",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN010409",
"LabelerName": "Citra Labs LLC",
"SubstanceName": "TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": "14",
"StrengthUnit": "g/30mL",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030710",
"SamplePackage": "N",
"IndicationAndUsage": "triCitrasol® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is an anticoagulant used in granulocytapheresis procedures (granulocyte collection by apheresis). Just prior to performing granulocytapheresis, aseptically add 30 mL of triCitrasol® to 500 mL of the 6% solution of Hydroxyethyl Starch (HES), e.g. Hespan ® 2-8. Agitate the resultant solution for 1 minute to assure a uniform concentration of anticoagulant. The resultant solution of triCitrasol® and 6% solution of HES contains the following concentration depending upon the volume used:. The triCitrasol®/HES solution is stable for up to 24 hours at room temperature after mixing. Refer to the manufacturer's Operator's Manual of the apheresis medical device for the directions to perform the granulocytapheresis procedure.",
"Description": "triCitrasol® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is a sterile, non-pyrogenic solution of Trisodium Citrate (Dihydrate), USP. Each 30 mL of concentrate contains:. pH adjusted with Citric Acid. pH: 6.3 – 6.6. Single patient use only, on a single occasion."
},
{
"NDCCode": "23731-6030-2",
"PackageDescription": "25 VIAL, SINGLE-USE in 1 CASE (23731-6030-2) / 30 mL in 1 VIAL, SINGLE-USE (23731-6030-3) ",
"NDC11Code": "23731-6030-02",
"ProductNDC": "23731-6030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tricitrasol",
"NonProprietaryName": "Trisodium Citrate Dihydrate",
"DosageFormName": "SOLUTION",
"RouteName": "EXTRACORPOREAL",
"StartMarketingDate": "20030710",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN010409",
"LabelerName": "Citra Labs LLC",
"SubstanceName": "TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": "14",
"StrengthUnit": "g/30mL",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030710",
"SamplePackage": "N",
"IndicationAndUsage": "triCitrasol® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is an anticoagulant used in granulocytapheresis procedures (granulocyte collection by apheresis). Just prior to performing granulocytapheresis, aseptically add 30 mL of triCitrasol® to 500 mL of the 6% solution of Hydroxyethyl Starch (HES), e.g. Hespan ® 2-8. Agitate the resultant solution for 1 minute to assure a uniform concentration of anticoagulant. The resultant solution of triCitrasol® and 6% solution of HES contains the following concentration depending upon the volume used:. The triCitrasol®/HES solution is stable for up to 24 hours at room temperature after mixing. Refer to the manufacturer's Operator's Manual of the apheresis medical device for the directions to perform the granulocytapheresis procedure.",
"Description": "triCitrasol® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is a sterile, non-pyrogenic solution of Trisodium Citrate (Dihydrate), USP. Each 30 mL of concentrate contains:. pH adjusted with Citric Acid. pH: 6.3 – 6.6. Single patient use only, on a single occasion."
},
{
"NDCCode": "43353-798-17",
"PackageDescription": "6030 TABLET in 1 BOTTLE, PLASTIC (43353-798-17) ",
"NDC11Code": "43353-0798-17",
"ProductNDC": "43353-798",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120507",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079098",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141121",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of Venlafaxine Hydrochloride Tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine HCl extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Venlafaxine tablets, USP immediate-release in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP immediate-release/venlafaxine HCl extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine hydrochloride (HCl), USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine HCl, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine HCl, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of anhydrous lactose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose,and sodium starch glycolate."
},
{
"NDCCode": "43353-856-17",
"PackageDescription": "6030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-856-17) ",
"NDC11Code": "43353-0856-17",
"ProductNDC": "43353-856",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077691",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131217",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets, USP can be started simultaneously with diet.",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol.Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol.Tablets simvastatin for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin USP and the following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red."
},
{
"NDCCode": "48951-6030-1",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BAG (48951-6030-1) > 7 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "48951-6030-01",
"ProductNDC": "48951-6030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Levisticum Quercus",
"NonProprietaryName": "Levisticum Quercus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "LEVISTICUM OFFICINALE ROOT; QUERCUS ROBUR WHOLE; BOS TAURUS EYE; BOS TAURUS NERVE",
"StrengthNumber": "6; 6; 8; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-10-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "54868-6030-0",
"PackageDescription": "1 POUCH in 1 CARTON (54868-6030-0) > 90 [USP'U] in 1 POUCH",
"NDC11Code": "54868-6030-00",
"ProductNDC": "54868-6030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Femring",
"NonProprietaryName": "Estradiol Acetate",
"DosageFormName": "RING",
"RouteName": "VAGINAL",
"StartMarketingDate": "20090504",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021367",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ESTRADIOL ACETATE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/24[USP'U]",
"Pharm_Classes": "Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Femring therapy is indicated in the. 1. Treatment of moderate to severe vasomotor symptoms due to menopause. 2. Treatment of moderate to severe vulvar and vaginal atrophy due to menopause.",
"Description": "Femring® (estradiol acetate vaginal ring) is an off-white, soft, flexible ring with a central core containing estradiol acetate. Femring is made of cured silicone elastomer composed of dimethyl polysiloxane silanol, silica (diatomaceous earth), normal propyl orthosilicate, stannous octoate; barium sulfate and estradiol acetate. The rings have the following dimensions: outer diameter 56 mm, cross-sectional diameter 7.6 mm, core diameter 2 mm. Femring is available in two strengths: Femring 0.05 mg/day has a central core that contains 12.4 mg of estradiol acetate, which releases at a rate equivalent to 0.05 mg of estradiol per day for 3 months. Femring 0.10 mg/day has a central core that contains 24.8 mg of estradiol acetate, which releases at a rate equivalent to 0.10 mg of estradiol per day for 3 months. Estradiol acetate is chemically described as estra-1,3,5(10)-triene-3,17β-diol-3-acetate. The molecular formula of estradiol acetate is C20H26O3 and the structural formula is. The molecular weight of estradiol acetate is 314.42."
},
{
"NDCCode": "60512-6030-0",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (60512-6030-0)",
"NDC11Code": "60512-6030-00",
"ProductNDC": "60512-6030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy",
"ProprietaryNameSuffix": "Real Relief",
"NonProprietaryName": "Allium Cepa, Arsenicum Album, Nux Vomica, Euphrasia Officinalis, Sabadilla, Sticta Pulmonaria, Aralia Racemosa, Cuprum Metallicum",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20121025",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HOMEOLAB USA INC.",
"SubstanceName": "ONION; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; ARALIA RACEMOSA ROOT; COPPER",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "This homeopathic medicine helps relieve symptoms of allergies. - nasal congestion. - runny nose. - sneezing. - itchy, watery eyes."
},
{
"NDCCode": "71610-606-17",
"PackageDescription": "6030 TABLET in 1 BOTTLE (71610-606-17) ",
"NDC11Code": "71610-0606-17",
"ProductNDC": "71610-606",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078627",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211025",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "73440-6030-1",
"PackageDescription": "170 g in 1 CAN (73440-6030-1) ",
"NDC11Code": "73440-6030-01",
"ProductNDC": "73440-6030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Solrx Sport Spf 30 C-spray",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Cross Brands Contract Filling",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "5.1; 25.5; 8.5; 13.6",
"StrengthUnit": "g/170g; g/170g; g/170g; g/170g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170104",
"SamplePackage": "N"
},
{
"NDCCode": "71971-6001-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-6001-0) > 90 TABLET in 1 BOTTLE",
"NDC11Code": "71971-6001-00",
"ProductNDC": "71971-6001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Eriodictyon Californicum, Histaminum, Ipecacuanha, Lobelia Inflata, Sambucus Nigra, Solidago Virgaurea",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma: 1 gasping for air, 2 difficulty breathing, 3 wheezing, 4 coughing, 5 excess mucus."
},
{
"NDCCode": "71971-6001-5",
"PackageDescription": "30 TABLET in 1 BOTTLE (71971-6001-5) ",
"NDC11Code": "71971-6001-05",
"ProductNDC": "71971-6001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Eriodictyon Californicum, Histaminum, Ipecacuanha, Lobelia Inflata, Sambucus Nigra, Solidago Virgaurea",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma: 1 gasping for air, 2 difficulty breathing, 3 wheezing, 4 coughing, 5 excess mucus."
},
{
"NDCCode": "71971-6002-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-6002-0) > 90 TABLET in 1 BOTTLE",
"NDC11Code": "71971-6002-00",
"ProductNDC": "71971-6002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Chamomila, Coffea Cruda, Eriodictyon Californicum, Histaminum, Ipecacuanha, Lobelia Inflata, Sambucus Nigra, Solidago Virgaurea",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "MATRICARIA CHAMOMILLA; ARABICA COFFEE BEAN; ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma: 1 gasping for air, 2 difficulty breathing, 3 wheezing, 4 coughing, 5 excess mucus."
},
{
"NDCCode": "71971-6002-5",
"PackageDescription": "30 TABLET in 1 BOTTLE (71971-6002-5) ",
"NDC11Code": "71971-6002-05",
"ProductNDC": "71971-6002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Chamomila, Coffea Cruda, Eriodictyon Californicum, Histaminum, Ipecacuanha, Lobelia Inflata, Sambucus Nigra, Solidago Virgaurea",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "MATRICARIA CHAMOMILLA; ARABICA COFFEE BEAN; ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma: 1 gasping for air, 2 difficulty breathing, 3 wheezing, 4 coughing, 5 excess mucus."
},
{
"NDCCode": "71971-6032-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-6032-0) > 90 TABLET in 1 BOTTLE",
"NDC11Code": "71971-6032-00",
"ProductNDC": "71971-6032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Arnica Montana, Bryonia, Causticum, Cinchona Officinalis, Dulcamara, Hydrastis Canadensis, Kali Bromatum, Sulphur",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; GOLDENSEAL; POTASSIUM BROMIDE; SULFUR",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated: 1 with tinnitus, 2 Rigging and buzzing in the ears, 3 Ear pain & pressure, 4 Headache."
},
{
"NDCCode": "71971-6032-5",
"PackageDescription": "30 TABLET in 1 BOTTLE (71971-6032-5) ",
"NDC11Code": "71971-6032-05",
"ProductNDC": "71971-6032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Arnica Montana, Bryonia, Causticum, Cinchona Officinalis, Dulcamara, Hydrastis Canadensis, Kali Bromatum, Sulphur",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; GOLDENSEAL; POTASSIUM BROMIDE; SULFUR",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated: 1 with tinnitus, 2 Rigging and buzzing in the ears, 3 Ear pain & pressure, 4 Headache."
},
{
"NDCCode": "71971-6036-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (71971-6036-0) > 90 TABLET in 1 BOTTLE",
"NDC11Code": "71971-6036-00",
"ProductNDC": "71971-6036",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Apis Mellifica, Arnica Montana, Benzoicum Acidum, Causticum, Colchicum Autumnale, Natrum Carbonicum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeolab International (Canada) inc",
"SubstanceName": "APIS MELLIFERA; ARNICA MONTANA; BENZOIC ACID; CAUSTICUM; COLCHICUM AUTUMNALE BULB; SODIUM CARBONATE",
"StrengthNumber": "8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Ammonium Ion Binding Activity [MoA], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated: 1 with arthritis, 2 joint pain, 3 stiffness, 4 inflammation, 5 soreness."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>71971-6030-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-6030-8) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-6030-08</NDC11Code>
<ProductNDC>71971-6030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Allium Cepa, Aralia Racemosa, Arsenicum Album, Cuprum Metallicum, Euphrasia Officinalis, Nux Vomica, Sabadilla, Sticta Pulmonaria</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>ONION; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; COPPER; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic remedy to relieve from symptoms of all allergies: 1 Nasal congestion, 2 Sneezing, 3 Runny nose, 4 Itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-6030-0</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-6030-0) > 90 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-6030-00</NDC11Code>
<ProductNDC>71971-6030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Allium Cepa, Aralia Racemosa, Arsenicum Album, Cuprum Metallicum, Euphrasia Officinalis, Nux Vomica, Sabadilla, Sticta Pulmonaria</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>ONION; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; COPPER; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic remedy to relieve from symptoms of all allergies: 1 Nasal congestion, 2 Sneezing, 3 Runny nose, 4 Itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-6030-5</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71971-6030-5) </PackageDescription>
<NDC11Code>71971-6030-05</NDC11Code>
<ProductNDC>71971-6030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Allium Cepa, Aralia Racemosa, Arsenicum Album, Cuprum Metallicum, Euphrasia Officinalis, Nux Vomica, Sabadilla, Sticta Pulmonaria</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>ONION; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; COPPER; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic remedy to relieve from symptoms of all allergies: 1 Nasal congestion, 2 Sneezing, 3 Runny nose, 4 Itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-6001-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-6001-8) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-6001-08</NDC11Code>
<ProductNDC>71971-6001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Eriodictyon Californicum, Histaminum, Ipecacuanha, Lobelia Inflata, Sambucus Nigra, Solidago Virgaurea</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma: 1 gasping for air, 2 difficulty breathing, 3 wheezing, 4 coughing, 5 excess mucus.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-6002-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-6002-8) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-6002-08</NDC11Code>
<ProductNDC>71971-6002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Chamomila, Coffea Cruda, Eriodictyon Californicum, Histaminum, Ipecacuanha, Lobelia Inflata, Sambucus Nigra, Solidago Virgaurea</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>MATRICARIA CHAMOMILLA; ARABICA COFFEE BEAN; ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma: 1 gasping for air, 2 difficulty breathing, 3 wheezing, 4 coughing, 5 excess mucus.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-6032-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-6032-8) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-6032-08</NDC11Code>
<ProductNDC>71971-6032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Arnica Montana, Bryonia, Causticum, Cinchona Officinalis, Dulcamara, Hydrastis Canadensis, Kali Bromatum, Sulphur</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; GOLDENSEAL; POTASSIUM BROMIDE; SULFUR</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated: 1 with tinnitus, 2 Rigging and buzzing in the ears, 3 Ear pain & pressure, 4 Headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-6036-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-6036-8) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-6036-08</NDC11Code>
<ProductNDC>71971-6036</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Apis Mellifica, Arnica Montana, Benzoicum Acidum, Causticum, Colchicum Autumnale, Natrum Carbonicum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>APIS MELLIFERA; ARNICA MONTANA; BENZOIC ACID; CAUSTICUM; COLCHICUM AUTUMNALE BULB; SODIUM CARBONATE</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ammonium Ion Binding Activity [MoA], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated: 1 with arthritis, 2 joint pain, 3 stiffness, 4 inflammation, 5 soreness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-9060-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-9060-8) > 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-9060-08</NDC11Code>
<ProductNDC>71971-9060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<ProprietaryNameSuffix>Teething Oral Liquid</ProprietaryNameSuffix>
<NonProprietaryName>Chamomilla, Arnica Montana, Borax, Hypericum Perforatum Liquid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>MATRICARIA RECUTITA; ARNICA MONTANA; SODIUM BORATE; HYPERICUM PERFORATUM</SubstanceName>
<StrengthNumber>5; 5; 5; 5</StrengthNumber>
<StrengthUnit>[hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by teething*. gum inflammation. gum pain. fever. diarrhea. restlessness and irritability.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-9062-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-9062-8) > 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-9062-08</NDC11Code>
<ProductNDC>71971-9062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Anas Barbariae Hepatis Et Cordis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/25mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made form an ingredient. traditionally used to temporarily help relieve flu-like symptoms*. fever aches pains chills feeling run-down.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-9066-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-9066-8) > 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-9066-08</NDC11Code>
<ProductNDC>71971-9066</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Pulsatilla, Allium Cepa, Arsenicum Album, Nux Vomica, Euphrasia Offinalis, Sabadilla, Aralia Racemosa, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190726</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>ANEMONE PULSATILLA; ONION; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED; ARALIA RACEMOSA ROOT; COPPER</SubstanceName>
<StrengthNumber>8; 6; 8; 6; 6; 6; 6; 8</StrengthNumber>
<StrengthUnit>[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by sinus symptoms*. sneezing nasal congestion runny nose itchy eyes, nose and throat watery eyes headache throat irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-9077-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-9077-8) > 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-9077-08</NDC11Code>
<ProductNDC>71971-9077</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Pulsatilla, Allium Cepa, Arsenicum Album, Nux Vomica, Euphrasia Offinalis, Sabadilla, Sticta Pulmonaria, Araila Racemosa, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>ANEMONE PULSATILLA; ONION; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; ARALIA RACEMOSA ROOT; COPPER</SubstanceName>
<StrengthNumber>8; 6; 8; 6; 6; 6; 6; 6; 8</StrengthNumber>
<StrengthUnit>[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of. ingredients traditionally used to help relieve allergy symptoms*. sneezing nasal congestion. throat and skin irritation teary eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-9083-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-9083-8) > 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-9083-08</NDC11Code>
<ProductNDC>71971-9083</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Colocynthis, Magnesia Phosphorica, Chamomilla, Dioscorea Villosa</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA; DIOSCOREA VILLOSA TUBER</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of. ingredients traditionally used to help relieve symptoms. associated with colic* intestinal gas abdominal pain. bloating nausea burping.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-9214-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-9214-8) > 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-9214-08</NDC11Code>
<ProductNDC>71971-9214</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Ferrum Phosphoricum, Capsicum Annuum, Pyrogenium, Arsenicum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>FERRUM PHOSPHORICUM; CAPSICUM; RANCID BEEF; ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This oral homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve* the sensa-. tion of fullness of the ear, sensitivity to water and drafts, and. the annoyance of water-clogged ears by helping clear water. trapped in the ear.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-9216-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-9216-8) > 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-9216-08</NDC11Code>
<ProductNDC>71971-9216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Arnica Montana, Ferrum Phosphoricum, Hypericum Perforatum, Thuja Occidentalis, Ledum Palustre</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>ARNICA MONTANA; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; THUJA OCCIDENTALIS LEAFY TWIG; RHODODENDRON TOMENTOSUM LEAFY TWIG</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of. ingredients traditionally used to help temporarily reduce. fever and relieve minor aches and pains associated with. common cold headache. sore throat toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23731-6030-1</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CASE (23731-6030-1) / 30 mL in 1 VIAL, SINGLE-USE (23731-6030-3) </PackageDescription>
<NDC11Code>23731-6030-01</NDC11Code>
<ProductNDC>23731-6030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tricitrasol</ProprietaryName>
<NonProprietaryName>Trisodium Citrate Dihydrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>EXTRACORPOREAL</RouteName>
<StartMarketingDate>20030710</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN010409</ApplicationNumber>
<LabelerName>Citra Labs LLC</LabelerName>
<SubstanceName>TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>triCitrasol® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is an anticoagulant used in granulocytapheresis procedures (granulocyte collection by apheresis). Just prior to performing granulocytapheresis, aseptically add 30 mL of triCitrasol® to 500 mL of the 6% solution of Hydroxyethyl Starch (HES), e.g. Hespan ® 2-8. Agitate the resultant solution for 1 minute to assure a uniform concentration of anticoagulant. The resultant solution of triCitrasol® and 6% solution of HES contains the following concentration depending upon the volume used:. The triCitrasol®/HES solution is stable for up to 24 hours at room temperature after mixing. Refer to the manufacturer's Operator's Manual of the apheresis medical device for the directions to perform the granulocytapheresis procedure.</IndicationAndUsage>
<Description>triCitrasol® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is a sterile, non-pyrogenic solution of Trisodium Citrate (Dihydrate), USP. Each 30 mL of concentrate contains:. pH adjusted with Citric Acid. pH: 6.3 – 6.6. Single patient use only, on a single occasion.</Description>
</NDC>
<NDC>
<NDCCode>23731-6030-2</NDCCode>
<PackageDescription>25 VIAL, SINGLE-USE in 1 CASE (23731-6030-2) / 30 mL in 1 VIAL, SINGLE-USE (23731-6030-3) </PackageDescription>
<NDC11Code>23731-6030-02</NDC11Code>
<ProductNDC>23731-6030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tricitrasol</ProprietaryName>
<NonProprietaryName>Trisodium Citrate Dihydrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>EXTRACORPOREAL</RouteName>
<StartMarketingDate>20030710</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN010409</ApplicationNumber>
<LabelerName>Citra Labs LLC</LabelerName>
<SubstanceName>TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>triCitrasol® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is an anticoagulant used in granulocytapheresis procedures (granulocyte collection by apheresis). Just prior to performing granulocytapheresis, aseptically add 30 mL of triCitrasol® to 500 mL of the 6% solution of Hydroxyethyl Starch (HES), e.g. Hespan ® 2-8. Agitate the resultant solution for 1 minute to assure a uniform concentration of anticoagulant. The resultant solution of triCitrasol® and 6% solution of HES contains the following concentration depending upon the volume used:. The triCitrasol®/HES solution is stable for up to 24 hours at room temperature after mixing. Refer to the manufacturer's Operator's Manual of the apheresis medical device for the directions to perform the granulocytapheresis procedure.</IndicationAndUsage>
<Description>triCitrasol® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is a sterile, non-pyrogenic solution of Trisodium Citrate (Dihydrate), USP. Each 30 mL of concentrate contains:. pH adjusted with Citric Acid. pH: 6.3 – 6.6. Single patient use only, on a single occasion.</Description>
</NDC>
<NDC>
<NDCCode>43353-798-17</NDCCode>
<PackageDescription>6030 TABLET in 1 BOTTLE, PLASTIC (43353-798-17) </PackageDescription>
<NDC11Code>43353-0798-17</NDC11Code>
<ProductNDC>43353-798</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120507</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079098</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of Venlafaxine Hydrochloride Tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine HCl extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Venlafaxine tablets, USP immediate-release in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP immediate-release/venlafaxine HCl extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine hydrochloride (HCl), USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine HCl, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine HCl, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of anhydrous lactose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose,and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>43353-856-17</NDCCode>
<PackageDescription>6030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-856-17) </PackageDescription>
<NDC11Code>43353-0856-17</NDC11Code>
<ProductNDC>43353-856</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077691</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets, USP can be started simultaneously with diet.</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol.Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol.Tablets simvastatin for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin USP and the following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</Description>
</NDC>
<NDC>
<NDCCode>48951-6030-1</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BAG (48951-6030-1) > 7 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>48951-6030-01</NDC11Code>
<ProductNDC>48951-6030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Levisticum Quercus</ProprietaryName>
<NonProprietaryName>Levisticum Quercus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>LEVISTICUM OFFICINALE ROOT; QUERCUS ROBUR WHOLE; BOS TAURUS EYE; BOS TAURUS NERVE</SubstanceName>
<StrengthNumber>6; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54868-6030-0</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (54868-6030-0) > 90 [USP'U] in 1 POUCH</PackageDescription>
<NDC11Code>54868-6030-00</NDC11Code>
<ProductNDC>54868-6030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Femring</ProprietaryName>
<NonProprietaryName>Estradiol Acetate</NonProprietaryName>
<DosageFormName>RING</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20090504</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021367</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ESTRADIOL ACETATE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/24[USP'U]</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Femring therapy is indicated in the. 1. Treatment of moderate to severe vasomotor symptoms due to menopause. 2. Treatment of moderate to severe vulvar and vaginal atrophy due to menopause.</IndicationAndUsage>
<Description>Femring® (estradiol acetate vaginal ring) is an off-white, soft, flexible ring with a central core containing estradiol acetate. Femring is made of cured silicone elastomer composed of dimethyl polysiloxane silanol, silica (diatomaceous earth), normal propyl orthosilicate, stannous octoate; barium sulfate and estradiol acetate. The rings have the following dimensions: outer diameter 56 mm, cross-sectional diameter 7.6 mm, core diameter 2 mm. Femring is available in two strengths: Femring 0.05 mg/day has a central core that contains 12.4 mg of estradiol acetate, which releases at a rate equivalent to 0.05 mg of estradiol per day for 3 months. Femring 0.10 mg/day has a central core that contains 24.8 mg of estradiol acetate, which releases at a rate equivalent to 0.10 mg of estradiol per day for 3 months. Estradiol acetate is chemically described as estra-1,3,5(10)-triene-3,17β-diol-3-acetate. The molecular formula of estradiol acetate is C20H26O3 and the structural formula is. The molecular weight of estradiol acetate is 314.42.</Description>
</NDC>
<NDC>
<NDCCode>60512-6030-0</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (60512-6030-0)</PackageDescription>
<NDC11Code>60512-6030-00</NDC11Code>
<ProductNDC>60512-6030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy</ProprietaryName>
<ProprietaryNameSuffix>Real Relief</ProprietaryNameSuffix>
<NonProprietaryName>Allium Cepa, Arsenicum Album, Nux Vomica, Euphrasia Officinalis, Sabadilla, Sticta Pulmonaria, Aralia Racemosa, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121025</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HOMEOLAB USA INC.</LabelerName>
<SubstanceName>ONION; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; ARALIA RACEMOSA ROOT; COPPER</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>This homeopathic medicine helps relieve symptoms of allergies. - nasal congestion. - runny nose. - sneezing. - itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-606-17</NDCCode>
<PackageDescription>6030 TABLET in 1 BOTTLE (71610-606-17) </PackageDescription>
<NDC11Code>71610-0606-17</NDC11Code>
<ProductNDC>71610-606</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078627</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>73440-6030-1</NDCCode>
<PackageDescription>170 g in 1 CAN (73440-6030-1) </PackageDescription>
<NDC11Code>73440-6030-01</NDC11Code>
<ProductNDC>73440-6030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Solrx Sport Spf 30 C-spray</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Cross Brands Contract Filling</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>5.1; 25.5; 8.5; 13.6</StrengthNumber>
<StrengthUnit>g/170g; g/170g; g/170g; g/170g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71971-6001-0</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-6001-0) > 90 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-6001-00</NDC11Code>
<ProductNDC>71971-6001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Eriodictyon Californicum, Histaminum, Ipecacuanha, Lobelia Inflata, Sambucus Nigra, Solidago Virgaurea</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma: 1 gasping for air, 2 difficulty breathing, 3 wheezing, 4 coughing, 5 excess mucus.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-6001-5</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71971-6001-5) </PackageDescription>
<NDC11Code>71971-6001-05</NDC11Code>
<ProductNDC>71971-6001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Eriodictyon Californicum, Histaminum, Ipecacuanha, Lobelia Inflata, Sambucus Nigra, Solidago Virgaurea</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma: 1 gasping for air, 2 difficulty breathing, 3 wheezing, 4 coughing, 5 excess mucus.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-6002-0</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-6002-0) > 90 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-6002-00</NDC11Code>
<ProductNDC>71971-6002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Chamomila, Coffea Cruda, Eriodictyon Californicum, Histaminum, Ipecacuanha, Lobelia Inflata, Sambucus Nigra, Solidago Virgaurea</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>MATRICARIA CHAMOMILLA; ARABICA COFFEE BEAN; ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma: 1 gasping for air, 2 difficulty breathing, 3 wheezing, 4 coughing, 5 excess mucus.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-6002-5</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71971-6002-5) </PackageDescription>
<NDC11Code>71971-6002-05</NDC11Code>
<ProductNDC>71971-6002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Chamomila, Coffea Cruda, Eriodictyon Californicum, Histaminum, Ipecacuanha, Lobelia Inflata, Sambucus Nigra, Solidago Virgaurea</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>MATRICARIA CHAMOMILLA; ARABICA COFFEE BEAN; ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma: 1 gasping for air, 2 difficulty breathing, 3 wheezing, 4 coughing, 5 excess mucus.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-6032-0</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-6032-0) > 90 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-6032-00</NDC11Code>
<ProductNDC>71971-6032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Arnica Montana, Bryonia, Causticum, Cinchona Officinalis, Dulcamara, Hydrastis Canadensis, Kali Bromatum, Sulphur</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; GOLDENSEAL; POTASSIUM BROMIDE; SULFUR</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated: 1 with tinnitus, 2 Rigging and buzzing in the ears, 3 Ear pain & pressure, 4 Headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-6032-5</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71971-6032-5) </PackageDescription>
<NDC11Code>71971-6032-05</NDC11Code>
<ProductNDC>71971-6032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Arnica Montana, Bryonia, Causticum, Cinchona Officinalis, Dulcamara, Hydrastis Canadensis, Kali Bromatum, Sulphur</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; GOLDENSEAL; POTASSIUM BROMIDE; SULFUR</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated: 1 with tinnitus, 2 Rigging and buzzing in the ears, 3 Ear pain & pressure, 4 Headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71971-6036-0</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71971-6036-0) > 90 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>71971-6036-00</NDC11Code>
<ProductNDC>71971-6036</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Apis Mellifica, Arnica Montana, Benzoicum Acidum, Causticum, Colchicum Autumnale, Natrum Carbonicum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeolab International (Canada) inc</LabelerName>
<SubstanceName>APIS MELLIFERA; ARNICA MONTANA; BENZOIC ACID; CAUSTICUM; COLCHICUM AUTUMNALE BULB; SODIUM CARBONATE</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ammonium Ion Binding Activity [MoA], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated: 1 with arthritis, 2 joint pain, 3 stiffness, 4 inflammation, 5 soreness.</IndicationAndUsage>
</NDC>
</NDCList>