{
"NDC": [
{
"NDCCode": "63388-920-44",
"PackageDescription": "30 mL in 1 BOTTLE (63388-920-44) ",
"NDC11Code": "63388-0920-44",
"ProductNDC": "63388-920",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Drosera, Arnica Montana, Bryonia, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum, Camomilla, Coffea Crudea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN; CHAMOMILE; ARABICA COFFEE BEAN",
"StrengthNumber": "1; 3; 3; 1; 3; 3; 3; 4; 4",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"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": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180303",
"SamplePackage": "N",
"IndicationAndUsage": "UsesThis homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains."
},
{
"NDCCode": "63388-910-44",
"PackageDescription": "30 mL in 1 BOTTLE (63388-910-44) ",
"NDC11Code": "63388-0910-44",
"ProductNDC": "63388-910",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Asafoetida, Ignatia Amara, Valeriana Officinalis, Avena Sativa, Argentum Nitricum, Hyoscyamus Niger, Paeonia Officinalis, Stramonium, Cocculus Indicus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIANA OFFICINALIS WHOLE; OAT BRAN; SILVER NITRATE; HYOSCYAMUS NIGER; PAEONIA OFFICINALIS ROOT; DATURA STRAMONIUM; ANAMIRTA COCCULUS WHOLE",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of. Restlessness nervousness irritability. agitation sleeplessness lessens nightmares."
},
{
"NDCCode": "49348-920-44",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (49348-920-44) > 15 TABLET in 1 BLISTER PACK",
"NDC11Code": "49348-0920-44",
"ProductNDC": "49348-920",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Womans Laxative",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100709",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "McKesson (Sunmark)",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100709",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "63388-920-45",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-920-45) / 100 mL in 1 BOTTLE",
"NDC11Code": "63388-0920-45",
"ProductNDC": "63388-920",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Drosera, Arnica Montana, Bryonia, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum, Camomilla, Coffea Crudea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN; CHAMOMILE; ARABICA COFFEE BEAN",
"StrengthNumber": "1; 3; 3; 1; 3; 3; 3; 4; 4",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"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": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180303",
"SamplePackage": "N",
"IndicationAndUsage": "UsesThis homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains."
},
{
"NDCCode": "63388-920-49",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-920-49) / 250 mL in 1 BOTTLE",
"NDC11Code": "63388-0920-49",
"ProductNDC": "63388-920",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Drosera, Arnica Montana, Bryonia, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum, Camomilla, Coffea Crudea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN; CHAMOMILE; ARABICA COFFEE BEAN",
"StrengthNumber": "1; 3; 3; 1; 3; 3; 3; 4; 4",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"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": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180303",
"SamplePackage": "N",
"IndicationAndUsage": "UsesThis homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains."
},
{
"NDCCode": "51655-920-26",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-920-26) ",
"NDC11Code": "51655-0920-26",
"ProductNDC": "51655-920",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090548",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220817",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin Calcium Tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemiaHypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C 66H 68CaF 2N 4O 10* C 3H 8O 2and its molecular weight is 1231.46 g/mol. Its structural formula is:. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide."
},
{
"NDCCode": "51655-920-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51655-920-30) ",
"NDC11Code": "51655-0920-30",
"ProductNDC": "51655-920",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090548",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140311",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin Calcium Tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemiaHypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C 66H 68CaF 2N 4O 10* C 3H 8O 2and its molecular weight is 1231.46 g/mol. Its structural formula is:. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide."
},
{
"NDCCode": "51655-920-83",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-920-83) ",
"NDC11Code": "51655-0920-83",
"ProductNDC": "51655-920",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090548",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230105",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin Calcium Tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemiaHypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C 66H 68CaF 2N 4O 10* C 3H 8O 2and its molecular weight is 1231.46 g/mol. Its structural formula is:. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide."
},
{
"NDCCode": "76354-920-01",
"PackageDescription": "1 BOTTLE in 1 BOX (76354-920-01) / 30 g in 1 BOTTLE",
"NDC11Code": "76354-0920-01",
"ProductNDC": "76354-920",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Camo Cc Cream Spf30 Tan 415 C",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "e.l.f. Cosmetics, Inc",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "75; 44.5; 137.2",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protecion measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "63388-643-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-643-02) / 25 mL in 1 BOTTLE",
"NDC11Code": "63388-0643-02",
"ProductNDC": "63388-643",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Infants Gas And Colic Relief",
"NonProprietaryName": "Colocynthis, Magnesia Phosphorica, Chamomilla, Dioscorea Villosa",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC; CHAMOMILE; DIOSCOREA VILLOSA ROOT",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140219",
"SamplePackage": "N",
"IndicationAndUsage": "This homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve symptoms associated with colic. intestinal gas. abdominal pain. bloating & hiccups. nausea. burping. upset stomach. *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice."
},
{
"NDCCode": "63388-910-45",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-910-45) / 100 mL in 1 BOTTLE",
"NDC11Code": "63388-0910-45",
"ProductNDC": "63388-910",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Asafoetida, Ignatia Amara, Valeriana Officinalis, Avena Sativa, Argentum Nitricum, Hyoscyamus Niger, Paeonia Officinalis, Stramonium, Cocculus Indicus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIANA OFFICINALIS WHOLE; OAT BRAN; SILVER NITRATE; HYOSCYAMUS NIGER; PAEONIA OFFICINALIS ROOT; DATURA STRAMONIUM; ANAMIRTA COCCULUS WHOLE",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of. Restlessness nervousness irritability. agitation sleeplessness lessens nightmares."
},
{
"NDCCode": "63388-910-49",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-910-49) / 250 mL in 1 BOTTLE",
"NDC11Code": "63388-0910-49",
"ProductNDC": "63388-910",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Asafoetida, Ignatia Amara, Valeriana Officinalis, Avena Sativa, Argentum Nitricum, Hyoscyamus Niger, Paeonia Officinalis, Stramonium, Cocculus Indicus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIANA OFFICINALIS WHOLE; OAT BRAN; SILVER NITRATE; HYOSCYAMUS NIGER; PAEONIA OFFICINALIS ROOT; DATURA STRAMONIUM; ANAMIRTA COCCULUS WHOLE",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of. Restlessness nervousness irritability. agitation sleeplessness lessens nightmares."
},
{
"NDCCode": "63388-912-14",
"PackageDescription": "30 mL in 1 BOTTLE (63388-912-14) ",
"NDC11Code": "63388-0912-14",
"ProductNDC": "63388-912",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Drosera, Arnica Montana, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; COCHINEAL; CORALLIUM RUBRUM WHOLE; TIN",
"StrengthNumber": "1; 3; 3; 3; 1; 3; 3; 3",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20180303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses This homeopathic medicine is made from a. combination of ingredients traditionally used to help. relieve symptoms associated with cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains."
},
{
"NDCCode": "63388-912-15",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-912-15) / 100 mL in 1 BOTTLE",
"NDC11Code": "63388-0912-15",
"ProductNDC": "63388-912",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
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"StrengthNumber": "1; 3; 3; 3; 1; 3; 3; 3",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
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"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Uses This homeopathic medicine is made from a. combination of ingredients traditionally used to help. relieve symptoms associated with cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains."
},
{
"NDCCode": "63388-912-19",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-912-19) / 250 mL in 1 BOTTLE",
"NDC11Code": "63388-0912-19",
"ProductNDC": "63388-912",
"ProductTypeName": "HUMAN OTC DRUG",
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"StrengthNumber": "1; 3; 3; 3; 1; 3; 3; 3",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Uses This homeopathic medicine is made from a. combination of ingredients traditionally used to help. relieve symptoms associated with cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains."
},
{
"NDCCode": "63388-915-14",
"PackageDescription": "30 mL in 1 BOTTLE (63388-915-14) ",
"NDC11Code": "63388-0915-14",
"ProductNDC": "63388-915",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Drosera, Arnica Montana, Bryonia, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum, Chamomilla, Coffee Crudea",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; TIN; CHAMOMILE; ARABICA COFFEE BEAN; CORALLIUM RUBRUM WHOLE",
"StrengthNumber": "1; 3; 3; 1; 3; 3; 4; 4; 3",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"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": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
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},
{
"NDCCode": "63388-915-15",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-915-15) / 100 mL in 1 BOTTLE",
"NDC11Code": "63388-0915-15",
"ProductNDC": "63388-915",
"ProductTypeName": "HUMAN OTC DRUG",
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"DosageFormName": "LIQUID",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; TIN; CHAMOMILE; ARABICA COFFEE BEAN; CORALLIUM RUBRUM WHOLE",
"StrengthNumber": "1; 3; 3; 1; 3; 3; 4; 4; 3",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"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",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
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},
{
"NDCCode": "63388-915-19",
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"StrengthNumber": "1; 3; 3; 1; 3; 3; 4; 4; 3",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"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": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20180303",
"SamplePackage": "N",
"IndicationAndUsage": "UsesThis homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold. dry cough cough with expectoration. chest congestion fever aches and pains."
},
{
"NDCCode": "63388-918-54",
"PackageDescription": "30 mL in 1 BOTTLE (63388-918-54) ",
"NDC11Code": "63388-0918-54",
"ProductNDC": "63388-918",
"ProductTypeName": "HUMAN OTC DRUG",
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"NonProprietaryName": "Drosera, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN",
"StrengthNumber": "1; 3; 3; 3; 1; 3; 3; 3",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: This homeopathic medicine is made from a combination of. ingredients traditionally used to help symptoms assiciated with. cough and cold* dry cough expectorant cough chest. congestion fever aches and pains."
},
{
"NDCCode": "63388-918-55",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-918-55) / 100 mL in 1 BOTTLE",
"NDC11Code": "63388-0918-55",
"ProductNDC": "63388-918",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Drosera, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN",
"StrengthNumber": "1; 3; 3; 3; 1; 3; 3; 3",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20180303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: This homeopathic medicine is made from a combination of. ingredients traditionally used to help symptoms assiciated with. cough and cold* dry cough expectorant cough chest. congestion fever aches and pains."
},
{
"NDCCode": "63388-918-59",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-918-59) / 250 mL in 1 BOTTLE",
"NDC11Code": "63388-0918-59",
"ProductNDC": "63388-918",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Drosera, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum",
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"RouteName": "ORAL",
"StartMarketingDate": "20180303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN",
"StrengthNumber": "1; 3; 3; 3; 1; 3; 3; 3",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20180303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: This homeopathic medicine is made from a combination of. ingredients traditionally used to help symptoms assiciated with. cough and cold* dry cough expectorant cough chest. congestion fever aches and pains."
},
{
"NDCCode": "63388-989-49",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-989-49) / 250 mL in 1 BOTTLE",
"NDC11Code": "63388-0989-49",
"ProductNDC": "63388-989",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Relief",
"NonProprietaryName": "Drosera, Arnica Montana, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum, Camomilla, Coffea Crudea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180503",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN; CHAMOMILE; ARABICA COFFEE BEAN",
"StrengthNumber": "1; 3; 3; 3; 1; 3; 3; 3; 4; 4",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"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": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20180503",
"SamplePackage": "N",
"IndicationAndUsage": "Uses This homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains."
},
{
"NDCCode": "63388-999-15",
"PackageDescription": "100 mL in 1 BOTTLE (63388-999-15) ",
"NDC11Code": "63388-0999-15",
"ProductNDC": "63388-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Drosera, Arnica Montana, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum, Camomilla, Coffea Crudea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180503",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN; CHAMOMILE; ARABICA COFFEE BEAN",
"StrengthNumber": "1; 3; 3; 3; 1; 3; 3; 3; 4; 4",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"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": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Uses This homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains."
},
{
"NDCCode": "63388-999-19",
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"NDC11Code": "63388-0999-19",
"ProductNDC": "63388-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Drosera, Arnica Montana, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum, Camomilla, Coffea Crudea",
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"RouteName": "ORAL",
"StartMarketingDate": "20180503",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN; CHAMOMILE; ARABICA COFFEE BEAN",
"StrengthNumber": "1; 3; 3; 3; 1; 3; 3; 3; 4; 4",
"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
"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": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180503",
"SamplePackage": "N",
"IndicationAndUsage": "Uses This homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains."
},
{
"NDCCode": "0338-0180-06",
"PackageDescription": "6 BAG in 1 CARTON (0338-0180-06) / 1000 mL in 1 BAG (0338-0180-01) ",
"NDC11Code": "00338-0180-06",
"ProductNDC": "0338-0180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970929",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020734",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE",
"StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 14",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200921",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0184-04",
"PackageDescription": "4 BAG in 1 CARTON (0338-0184-04) / 2000 mL in 1 BAG (0338-0184-01) ",
"NDC11Code": "00338-0184-04",
"ProductNDC": "0338-0184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970929",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020734",
"LabelerName": "Baxter Healthcare Corporation",
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"Description": "CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum."
},
{
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"PackageDescription": "6 BAG in 1 CARTON (0338-0188-06) / 1000 mL in 1 BAG (0338-0188-01) ",
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"Description": "CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum."
},
{
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"PackageDescription": "4 BAG in 1 CARTON (0338-0194-04) / 2000 mL in 1 BAG (0338-0194-01) ",
"NDC11Code": "00338-0194-04",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Description": "CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum."
},
{
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"PackageDescription": "6 BAG in 1 CARTON (0338-0202-06) / 1000 mL in 1 BAG (0338-0202-01) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"DosageFormName": "INJECTION",
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"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
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"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
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"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
},
{
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"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
}
]
}
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<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>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of. Restlessness nervousness irritability. agitation sleeplessness lessens nightmares.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49348-920-44</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (49348-920-44) > 15 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49348-0920-44</NDC11Code>
<ProductNDC>49348-920</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Womans Laxative</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100709</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>McKesson (Sunmark)</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100709</StartMarketingDatePackage>
<EndMarketingDatePackage>20191231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63388-920-45</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63388-920-45) / 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63388-0920-45</NDC11Code>
<ProductNDC>63388-920</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Drosera, Arnica Montana, Bryonia, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum, Camomilla, Coffea Crudea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN; CHAMOMILE; ARABICA COFFEE BEAN</SubstanceName>
<StrengthNumber>1; 3; 3; 1; 3; 3; 3; 4; 4</StrengthNumber>
<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</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>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesThis homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-920-49</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63388-920-49) / 250 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63388-0920-49</NDC11Code>
<ProductNDC>63388-920</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
<NonProprietaryName>Drosera, Arnica Montana, Bryonia, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum, Camomilla, Coffea Crudea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN; CHAMOMILE; ARABICA COFFEE BEAN</SubstanceName>
<StrengthNumber>1; 3; 3; 1; 3; 3; 3; 4; 4</StrengthNumber>
<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</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>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesThis homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51655-920-26</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-920-26) </PackageDescription>
<NDC11Code>51655-0920-26</NDC11Code>
<ProductNDC>51655-920</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090548</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin Calcium Tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemiaHypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C 66H 68CaF 2N 4O 10* C 3H 8O 2and its molecular weight is 1231.46 g/mol. Its structural formula is:. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51655-920-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51655-920-30) </PackageDescription>
<NDC11Code>51655-0920-30</NDC11Code>
<ProductNDC>51655-920</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090548</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin Calcium Tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemiaHypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C 66H 68CaF 2N 4O 10* C 3H 8O 2and its molecular weight is 1231.46 g/mol. Its structural formula is:. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51655-920-83</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-920-83) </PackageDescription>
<NDC11Code>51655-0920-83</NDC11Code>
<ProductNDC>51655-920</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090548</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin Calcium Tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemiaHypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C 66H 68CaF 2N 4O 10* C 3H 8O 2and its molecular weight is 1231.46 g/mol. Its structural formula is:. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76354-920-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (76354-920-01) / 30 g in 1 BOTTLE</PackageDescription>
<NDC11Code>76354-0920-01</NDC11Code>
<ProductNDC>76354-920</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Camo Cc Cream Spf30 Tan 415 C</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>e.l.f. Cosmetics, Inc</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>75; 44.5; 137.2</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protecion measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-643-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63388-643-02) / 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63388-0643-02</NDC11Code>
<ProductNDC>63388-643</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Infants Gas And Colic Relief</ProprietaryName>
<NonProprietaryName>Colocynthis, Magnesia Phosphorica, Chamomilla, Dioscorea Villosa</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC; CHAMOMILE; DIOSCOREA VILLOSA ROOT</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve symptoms associated with colic. intestinal gas. abdominal pain. bloating & hiccups. nausea. burping. upset stomach. *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-910-45</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63388-910-45) / 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63388-0910-45</NDC11Code>
<ProductNDC>63388-910</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Asafoetida, Ignatia Amara, Valeriana Officinalis, Avena Sativa, Argentum Nitricum, Hyoscyamus Niger, Paeonia Officinalis, Stramonium, Cocculus Indicus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIANA OFFICINALIS WHOLE; OAT BRAN; SILVER NITRATE; HYOSCYAMUS NIGER; PAEONIA OFFICINALIS ROOT; DATURA STRAMONIUM; ANAMIRTA COCCULUS WHOLE</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of. Restlessness nervousness irritability. agitation sleeplessness lessens nightmares.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-910-49</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63388-910-49) / 250 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63388-0910-49</NDC11Code>
<ProductNDC>63388-910</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Asafoetida, Ignatia Amara, Valeriana Officinalis, Avena Sativa, Argentum Nitricum, Hyoscyamus Niger, Paeonia Officinalis, Stramonium, Cocculus Indicus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIANA OFFICINALIS WHOLE; OAT BRAN; SILVER NITRATE; HYOSCYAMUS NIGER; PAEONIA OFFICINALIS ROOT; DATURA STRAMONIUM; ANAMIRTA COCCULUS WHOLE</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of. Restlessness nervousness irritability. agitation sleeplessness lessens nightmares.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-912-14</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63388-912-14) </PackageDescription>
<NDC11Code>63388-0912-14</NDC11Code>
<ProductNDC>63388-912</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Drosera, Arnica Montana, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; COCHINEAL; CORALLIUM RUBRUM WHOLE; TIN</SubstanceName>
<StrengthNumber>1; 3; 3; 3; 1; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
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<SamplePackage>N</SamplePackage>
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<NDC>
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<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Status>Active</Status>
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<SamplePackage>N</SamplePackage>
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<NDC>
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<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
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<IndicationAndUsage>Uses: This homeopathic medicine is made from a combination of. ingredients traditionally used to help symptoms assiciated with. cough and cold* dry cough expectorant cough chest. congestion fever aches and pains.</IndicationAndUsage>
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<IndicationAndUsage>Uses: This homeopathic medicine is made from a combination of. ingredients traditionally used to help symptoms assiciated with. cough and cold* dry cough expectorant cough chest. congestion fever aches and pains.</IndicationAndUsage>
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<IndicationAndUsage>Uses: This homeopathic medicine is made from a combination of. ingredients traditionally used to help symptoms assiciated with. cough and cold* dry cough expectorant cough chest. congestion fever aches and pains.</IndicationAndUsage>
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<IndicationAndUsage>Uses This homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
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<IndicationAndUsage>Uses This homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses This homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
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<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020734</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 14</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0184-04</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (0338-0184-04) / 2000 mL in 1 BAG (0338-0184-01) </PackageDescription>
<NDC11Code>00338-0184-04</NDC11Code>
<ProductNDC>0338-0184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020734</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 14</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0188-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0338-0188-06) / 1000 mL in 1 BAG (0338-0188-01) </PackageDescription>
<NDC11Code>00338-0188-06</NDC11Code>
<ProductNDC>0338-0188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020734</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 515; 920; 544; 400; 32; 10</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0194-04</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (0338-0194-04) / 2000 mL in 1 BAG (0338-0194-01) </PackageDescription>
<NDC11Code>00338-0194-04</NDC11Code>
<ProductNDC>0338-0194</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020734</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 10</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0202-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0338-0202-06) / 1000 mL in 1 BAG (0338-0202-01) </PackageDescription>
<NDC11Code>00338-0202-06</NDC11Code>
<ProductNDC>0338-0202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0206-04</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (0338-0206-04) / 2000 mL in 1 BAG (0338-0206-01) </PackageDescription>
<NDC11Code>00338-0206-04</NDC11Code>
<ProductNDC>0338-0206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
</NDCList>