{
"NDC": [
{
"NDCCode": "59088-180-58",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (59088-180-58) ",
"NDC11Code": "59088-0180-58",
"ProductNDC": "59088-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zintrexyl-c",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210211",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 30; 1; .75; 37.5; 25; 24.5; 25",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210211",
"SamplePackage": "N",
"IndicationAndUsage": "Zintrexyl-C TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Full Prescribing Information. Each Serving Size of 2 caplets contain. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake)."
},
{
"NDCCode": "59088-096-58",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (59088-096-58) > 1 KIT in 1 BLISTER PACK * 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "59088-0096-58",
"ProductNDC": "59088-096",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatal, Dha",
"NonProprietaryName": "Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Ascorbic Acid, Niacin, Folic Acid, Ferrous Fumarate, Calcium Carbonate, Cholecalciferol, Vitamin E Acetate, Potassium Iodide, Zinc Oxide, Choline Bitartrate, And Doconexent",
"DosageFormName": "KIT",
"StartMarketingDate": "20170810",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2020-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170810",
"SamplePackage": "N"
},
{
"NDCCode": "59088-181-58",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (59088-181-58) ",
"NDC11Code": "59088-0181-58",
"ProductNDC": "59088-181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folitin-z",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210211",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 30; 1; .75; 37.5; 25; 24.5; 25",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210211",
"SamplePackage": "N",
"IndicationAndUsage": "Folitin-Z TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occurs together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Full Prescribing Information. Each Serving Size of 2 caplets contain. Vitamin A (as Retinyl Acetate)................................................... 3000 mcg RAE Vitamin C (as Ascorbic Acid)............................................................... 500 mg Vitamin D (as Cholecalciferol).......................................... 3 27.5 mcg (1100 IU) Vitamin E (as DL-alpha Tocopheryl Acetate)........................................... 90 mg Thiamin (as Thiamine Mononitrate)....................................................... 6.5 mg Riboflavin ............................................................................................. 6.7 mg Niacin (as Niacinamide)......................................................................... 45 mg Vitamin B6 (as Pyridoxine HCl)............................................................... 12 mg. Folate 1700 mcg DFE. (as L-5-Methyltetrahydrofolate calcium salt).........(1000 mcg as L-Methyfolate). Vitamin B12 (as Methylcobalamin)....................................................... 26 mcg Biotin ................................................................................................ 200 mcg Pantothenic Acid (as Calcium Pantothenate)........................................... 30 mg Calcium (as Calcium Carbonate)...........................................................150 mg Iron (as Ferrous Fumarate)......................................................................18 mg Iodine (as Potassium Iodide)................................................................50 mcg Magnesium (as Magnesium Oxide)........................................................ 75 mg Zinc (as Zinc Gluconate)......................................................................... 30 mg Selenium (as Selenomethionine)...........................................................60 mcg Copper (as Copper Oxide)....................................................................... 2 mg Manganese (as Manganese Sulfate).......................................................1.5 mg Chromium (as Chromium Polynicotinate)..............................................75 mcg Molybdenum (as Sodium Molybdate)................................................... 50 mcg Potassium (as Potassium Chloride)....................................................... 49 mg Boron (as Boron Citrate)...................................................................... 50 mcg. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake)."
},
{
"NDCCode": "59088-182-58",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (59088-182-58) ",
"NDC11Code": "59088-0182-58",
"ProductNDC": "59088-182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribotin-e",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210211",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 30; 1; .75; 37.5; 25; 24.5; 25",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210211",
"SamplePackage": "N",
"IndicationAndUsage": "Ribotin-E TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Full Prescribing Information. Each Serving Size of 2 caplets contain. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake)."
},
{
"NDCCode": "59088-480-58",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (59088-480-58) ",
"NDC11Code": "59088-0480-58",
"ProductNDC": "59088-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Foliflex",
"NonProprietaryName": "Ferrous Fumarate, Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211025",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 30; 1; .75; 37.5; 25; 24.5; 25",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211025",
"SamplePackage": "N",
"IndicationAndUsage": "Foliflex TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Full Prescribing Information. Each Serving Size of 2 caplets contain. Vitamin A (as Retinyl Acetate) 3000 mcg RAE Vitamin C (as Ascorbic Acid) 500 mg Vitamin D3 (as Cholecalciferol) 27.5 mcg (1100 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) 90 mg Thiamin (as Thiamine Mononitrate) 6.5 mg Riboflavin 6.7 mg Niacin (as Niacinamide) 45 mg Vitamin B6 (as Pyridoxine HCl) 12 mg Folate 1700 mcg DFE (as L-5-Methyltetrahydrofolate calcium salt) (1000 mcg as L-Methyfolate) Vitamin B12 (as Methylcobalamin) 26 mcg Biotin 200 mcg Pantothenic Acid (as Calcium Pantothenate) 30 mg Calcium (as Calcium Carbonate) 150 mg Iron (as Ferrous Fumarate) 18 mg Iodine (as Potassium Iodide) 50 mcg Magnesium (as Magnesium Oxide) 75 mg Zinc (as Zinc Gluconate) 30 mg Selenium (as Selenomethionine) 60 mcg Copper (as Copper Oxide) 2 mg Manganese (as Manganese Sulfate) 1.5 mg Chromium (as Chromium Polynicotinate) 75 mcg Molybdenum (as Sodium Molybdate) 50 mcg Potassium (as Potassium Chloride) 49 mg Boron (as Boron Citrate) 50 mcg. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake)."
},
{
"NDCCode": "0172-4960-58",
"PackageDescription": "180 CAPSULE in 1 BOTTLE (0172-4960-58)",
"NDC11Code": "00172-4960-58",
"ProductNDC": "0172-4960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flutamide",
"NonProprietaryName": "Flutamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010919",
"EndMarketingDate": "20180531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075780",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "FLUTAMIDE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-06-01",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "11527-180-58",
"PackageDescription": "119 g in 1 TUBE (11527-180-58) ",
"NDC11Code": "11527-0180-58",
"ProductNDC": "11527-180",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tanners Tasty Vanilla Bling",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "ORAL",
"StartMarketingDate": "20120710",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Sheffield Pharmaceuticals LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.43",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2023-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120710",
"SamplePackage": "N",
"IndicationAndUsage": "Aids in the prevention of dental decay."
},
{
"NDCCode": "16729-180-58",
"PackageDescription": "300 TABLET in 1 BOTTLE (16729-180-58)",
"NDC11Code": "16729-0180-58",
"ProductNDC": "16729-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202553",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-05-22"
},
{
"NDCCode": "69816-680-06",
"PackageDescription": "1 KIT in 1 BOX (69816-680-06) * 6 g in 1 JAR (69816-180-01) * 58.8 g in 1 JAR (69816-100-01)",
"NDC11Code": "69816-0680-06",
"ProductNDC": "69816-680",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ibuprofen 10 Percent Topical",
"DosageFormName": "KIT",
"StartMarketingDate": "20150727",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "MaxPac, LLC",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "71160-180-58",
"PackageDescription": "58 mL in 1 BOTTLE (71160-180-58) ",
"NDC11Code": "71160-0180-58",
"ProductNDC": "71160-180",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170109",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "TEKWELD SOLUTIONS, INC.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "620",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240215",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "79846-101-58",
"PackageDescription": "180 CLOTH in 1 PAIL (79846-101-58) ",
"NDC11Code": "79846-0101-58",
"ProductNDC": "79846-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Disinfectant Wipes (75% Alcohol)",
"NonProprietaryName": "Ethanol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200727",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Jintu Handicraft Factory",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "3",
"StrengthUnit": "mL/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200727",
"SamplePackage": "N",
"IndicationAndUsage": "Unfold towelette, wipe hands, discard after use. Rub thoroughly into hands for at least 30 seconds, allow to dry."
},
{
"NDCCode": "79846-151-58",
"PackageDescription": "180 CLOTH in 1 PAIL (79846-151-58) ",
"NDC11Code": "79846-0151-58",
"ProductNDC": "79846-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Sanitizing Wipes (0.13% Benzalkonium Chloride)",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200727",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Jintu Handicraft Factory",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "5.2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200727",
"SamplePackage": "N",
"IndicationAndUsage": "Unfold towelette, wipe hands, discard after use. Rub thoroughly into hands for at least 30 seconds, allow to dry."
},
{
"NDCCode": "36800-107-58",
"PackageDescription": "1 BOTTLE in 1 CARTON (36800-107-58) > 40 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "36800-0107-58",
"ProductNDC": "36800-107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Allergy Relief",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-11-26",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "46122-040-58",
"PackageDescription": "1 BOTTLE in 1 CARTON (46122-040-58) > 40 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "46122-0040-58",
"ProductNDC": "46122-040",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Allergy Relief",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-10-05"
},
{
"NDCCode": "46122-779-58",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (46122-779-58) / 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "46122-0779-58",
"ProductNDC": "46122-779",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hydrochloride",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091567",
"LabelerName": "AMERISOURCE BERGEN",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240514",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "52959-689-08",
"PackageDescription": "180 TABLET in 1 BOTTLE (52959-689-08)",
"NDC11Code": "52959-0689-08",
"ProductNDC": "52959-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076286",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Tizanidine tablets are a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).",
"Description": "Tizanidine hydrochloride USP, is a centrally acting α2-adrenergic agonist. Tizanidine HCl USP (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine’s molecular formula is C9H8ClN5S.HCl, its molecular weight is 290.2 and its structural formula is. Tizanidine tablets USP, is supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets USP, are composed of the active ingredient, tizanidine hydrochloride USP (2.29 mg equivalent to 2 mg tizanidine base and 4.58 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, microcrystalline cellulose, colloidal silicon dioxide and stearic acid."
},
{
"NDCCode": "62207-766-58",
"PackageDescription": "7 BLISTER PACK in 1 CARTON (62207-766-58) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "62207-0766-58",
"ProductNDC": "62207-766",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hydrochloride",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211075",
"LabelerName": "Granules India Ltd",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201218",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
},
{
"NDCCode": "62207-891-58",
"PackageDescription": "7 BLISTER PACK in 1 CARTON (62207-891-58) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "62207-0891-58",
"ProductNDC": "62207-891",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hydrochloride",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211075",
"LabelerName": "Granules India Limited",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231107",
"SamplePackage": "N",
"IndicationAndUsage": "reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring."
},
{
"NDCCode": "59088-003-81",
"PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (59088-003-81) ",
"NDC11Code": "59088-0003-81",
"ProductNDC": "59088-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bruselix Bruising",
"NonProprietaryName": "Vitamin C, Zinc, Arnica Montana Extract, Bromelain, Diosmin, Rutin, Citrus Bioflavonoids, Hesperidin Methyl Chalcone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241011",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Puretek Corporation",
"SubstanceName": "ARNICA MONTANA FLOWER; STEM BROMELAIN; SODIUM ASCORBATE; HESPERIDIN METHYLCHALCONE; RUTIN; DIOSMIN; HESPERIDIN; ZINC PICOLINATE",
"StrengthNumber": "50; 400; 120; 25; 50; 200; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241011",
"SamplePackage": "N",
"IndicationAndUsage": "Bruselix Bruising Tablets are formulated to provide nutritional support during the body’s natural recovery process. They may be helpful for individuals experiencing bruising due to minor injuries, surgical procedures, or sensitive skin. The formula contains antioxidants, enzymes, and natural extracts that are traditionally used to support overall skin health and recovery.",
"Description": "Active Ingredients Each tablet contains: Vitamin C (as Sodium Ascorbate) ...............................................................120 mg Zinc (as Zinc Picolinate) ...............................................................................10 mg Arnica Montana Extract 10:1 (equivalent to 500 mg Arnica Montana Powder) ...50 mg Bromelain 2400 GDU/g (from Pineapple) ...................................................400 mg Diosmin (Citrus Aurantium) Fruit Extract.....................................................200 mg Rutin (Sophora Japonica) Flower Extract......................................................50 mg Citrus Bioflavonoids (from pulp and peel of lemon, orange, quince) ............25 mg Hesperidin Methyl Chalcone..........................................................................25 mg. Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (Vegetable Source), Coating (Hydroxypropyl Methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-005-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-005-54) ",
"NDC11Code": "59088-0005-54",
"ProductNDC": "59088-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multitol-m",
"NonProprietaryName": "Multivitamin, Folate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240417",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE",
"StrengthNumber": "13.5; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 2040; 8; 200; 1500; 3; 25; 2.3",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240417",
"SamplePackage": "N",
"IndicationAndUsage": "Multitol-M is indicated to provide vitamins and minerals supplement to men and women. Folate is effective in the treatment of megaloblastic anemias due to a deficiency of folate (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Each caplet contains. Vitamin A (as Retinyl Acetate)………………........ 1500 mcg RAE Vitamin C (as Ascorbic Acid) .………………..………...… 120 mg Vitamin D3 (As Cholecalciferol) ..……………….. 20 mcg (800 IU) Vitamin E (DL-alpha Tocopheryl Acetate) .……………….. 13.5 mg Thiamin (As Thiamine Mononitrate) …….………………..… 3 mg Riboflavin …………………………….….…..………….... 3.4 mg Niacin (as Niacinamide)…………………………………… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride)…………………. 20 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)………………………….. 8 mcg Calcium (as Calcium Carbonate)…………………………. 200 mg Magnesium (as Magnesium Oxide)……………………… 200 mg Zinc (as Zinc Oxide)……………………………………….. 25 mg Selenium (as Selenium Amino Acid Chelate)……………. 55 mcg Manganese (as Manganese Sulfate)……………………… 2.3 mg Chromium (as Chromium Polynicotinate)……………….. 35 mcg Molybdenum (as Molybdenum Amino Acid Chelate).……. 45 mcg Other Ingredients: Organic Cocoa Powder, Croscarmellose Sodium, Crospovidone, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid. Coating: (Hydroxypropyl Methylcellulose [HPMC], PEG-8)."
},
{
"NDCCode": "59088-008-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-008-54) ",
"NDC11Code": "59088-0008-54",
"ProductNDC": "59088-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finazol",
"NonProprietaryName": "Ferrous Fumarate, Folate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241011",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC CITRATE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 200; 10; 45; 3.25; 3.35; 22.5; 6; 1000; 26; 100; 15; 100; 18; 25; 50; 30; 30; 1; .75; 37.5; 25; 24.5; 25",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [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], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241011",
"SamplePackage": "N",
"IndicationAndUsage": "Finazol is indicated for iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also, for conditions in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Full Prescribing Information: DESCRIPTION: Active Ingredients: Each caplet contains: Vitamin A (as Retinyl Acetate) ……………………………….....1500 mcg RAE Vitamin C (as Ascorbic Acid) ….…..….…………………….……….....200 mg Vitamin D3 (as Cholecalciferol) ….…………………………....10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) ………………………….....45 mg Thiamin (as Thiamine Mononitrate) …..…..…………………………...3.25 mg Riboflavin (as Vitamin B2) …..…..…..…..………………………….…3.35 mg Niacin (as Niacinamide)……………………………………………..…22.5 mg Vitamin B6 (as Pyridoxine HCl)……………………………………………6 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …………………1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)……………………………………..26 mcg Biotin………………………………………………………………….100 mcg Pantothenic Acid (as Calcium Pantothenate)………………………….....15 mg Calcium (as Calcium Carbonate)………………………………………..100 mg Iron (as Ferrous Fumarate)……………………………………………....18 mg Iodine (as Potassium Iodide)…………………………………………...25 mcg Magnesium (as Magnesium Oxide)……………………………………...50 mg Zinc (as Zinc Citrate)……………………………………………………..30 mg Selenium (as Selenomethionine)….…………………………………….30 mcg Copper (as Copper Oxide)………………………………………………....1 mg Manganese (as Manganese Sulfate)…………………………………...0.75 mg Chromium (as Chromium Polynicotinate)…………………………….37.5 mcg Molybdenum (as Sodium Molybdate)…………………………………..25 mcg Potassium (as Potassium Chloride) ……………………………….…..24.5 mg Boron (as Boron Citrate)……………………………………..…………25 mcg. Other Ingredients: Crospovidone, Dextrin, Dextrose Monohydrate, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Purified Stearic Acid, Silicon Dioxide, Sodium Carboxymethylcellulose, Titanium Dioxide."
},
{
"NDCCode": "59088-009-54",
"PackageDescription": "30 TABLET in 1 BOTTLE (59088-009-54) ",
"NDC11Code": "59088-0009-54",
"ProductNDC": "59088-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatol-m",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240506",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHOLECALCIFEROL; FERROUS FUMARATE; MOLYBDENUM; ASCORBIC ACID; ZINC OXIDE; CHOLINE BITARTRATE; RIBOFLAVIN; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; VITAMIN A ACETATE; SELENIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CALCIUM CARBONATE; CHROMIUM NICOTINATE; MANGANESE SULFATE; POTASSIUM IODIDE; METHYLCOBALAMIN; LEVOMEFOLATE CALCIUM; THIAMINE MONONITRATE",
"StrengthNumber": "20; 27; 50; 120; 25; 55; 3.4; 200; 13.5; 1500; 70; 20; 50; 200; 45; 2.6; 150; 10; 2040; 3",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240506",
"SamplePackage": "N",
"IndicationAndUsage": "Indications and Usage: Prenatol-M is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatol-M may be beneficial in improving the nutritional status of women prior to conception.",
"Description": "Each caplet contains: Vitamin A (as Retinyl Acetate) ………………....… 1500 mcg RAE Vitamin C (as Ascorbic Acid) ………………….………… 120 mg Vitamin D3 (as Cholecalciferol).……………....... 20 mcg (800 IU) Vitamin E (as Dl-Alpha Tocopheryl Acetate) ….......….…. 13.5 mg Thiamin (as Thiamine Mononitrate) …………...…………… 3 mg Riboflavin ……………………….…………………….…. 3.4 mg Niacin (as Niacinamide) ………………..……………….… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride) …....…………... 50 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) ….... 2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin) ……….……………... 10 mcg Choline (as Choline Bitartrate) …….……………………… 55 mg Calcium (as Calcium Carbonate) ……...…………………. 200 mg Iron (as Ferrous Fumarate) ………..……………………… 27 mg Iodine (as Potassium Iodine) …...……………………….150 mcg Magnesium (as Magnesium Oxide) …...………………… 200 mg Zinc (as Zinc Oxide) ………………...…………………….. 25 mg Selenium (as Selenium Amino Acid Chelate) ……………. 70 mcg Manganese (as Manganese Sulfate) ……………………… 2.6 mg Chromium (as Chromium Polynicotinate) ……………….. 45 mcg Molybdenum (as Molybdenum Amino Acid Chelate)…...… 50 mcg."
},
{
"NDCCode": "59088-013-06",
"PackageDescription": "60 g in 1 JAR (59088-013-06) ",
"NDC11Code": "59088-0013-06",
"ProductNDC": "59088-013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Methylten",
"NonProprietaryName": "Methyl Salicylate 10%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250113",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Puretek Corporation",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250113",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints."
},
{
"NDCCode": "59088-014-06",
"PackageDescription": "60 g in 1 JAR (59088-014-06) ",
"NDC11Code": "59088-0014-06",
"ProductNDC": "59088-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Methyl Salicylate 25%",
"ProprietaryNameSuffix": "Pain Relieving",
"NonProprietaryName": "Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Puretek Corporation",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains."
},
{
"NDCCode": "59088-015-54",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-015-54) ",
"NDC11Code": "59088-0015-54",
"ProductNDC": "59088-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flotrex",
"NonProprietaryName": "Multivitamins, Sodium Fluoride 0.5 Mg",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250221",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".5; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250221",
"SamplePackage": "N",
"IndicationAndUsage": "This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.",
"Description": "Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid)....................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 0.5 mg. Flotrex Multivitamin Chewable plus 0.5 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.5 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet."
},
{
"NDCCode": "59088-017-54",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-017-54) ",
"NDC11Code": "59088-0017-54",
"ProductNDC": "59088-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flotrex",
"NonProprietaryName": "Multivitamins, Sodium Fluoride 0.25 Mg",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250319",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".25; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250319",
"SamplePackage": "N",
"IndicationAndUsage": "This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.",
"Description": "Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid) ...................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ................................................................... 0.25 mg. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Stearic Acid (vegetable source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet."
},
{
"NDCCode": "59088-018-54",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-018-54) ",
"NDC11Code": "59088-0018-54",
"ProductNDC": "59088-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multivitamin",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN",
"StrengthNumber": "750; 24; 36; 10; 10; 1.05; 1.05; 1.2; 13.5; 1000; 4.5",
"StrengthUnit": "ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Multivitamin Chewable Tablets is indicated to provide significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.",
"Description": "Vitamin A (as Retinyl Acetate).................................... 750 mcg RAE. Vitamin C (as Sodium Ascorbate and Ascorbic Acid).............. 60 mg. Vitamin D3 (as Cholecalciferol)............................................ 10 mcg. Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 10 mg. Thiamin (as Thiamine Mononitrate).................................... 1.05 mg. Riboflavin............................................................................... 1.2 mg. Niacin (as Niacinamide)....................................................... 13.5 mg. Vitamin B6 (as Pyridoxine Hydrochloride).......................... 1.05 mg. Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE. (1000 mcg as L-5-Methylfolate). Vitamin B12 (as Methylcobalamin)..................................... 4.5 mcg."
},
{
"NDCCode": "59088-020-54",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-020-54) ",
"NDC11Code": "59088-0020-54",
"ProductNDC": "59088-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flotrex",
"NonProprietaryName": "Multivitamins, Sodium Fluoride 1 Mg",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250710",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "1; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250710",
"SamplePackage": "N",
"IndicationAndUsage": "This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.",
"Description": "Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid)....................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 1 mg. Flotrex Multivitamin Chewable plus 1 mg Fluoride Tablets Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 1 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet."
},
{
"NDCCode": "59088-022-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-022-54) ",
"NDC11Code": "59088-0022-54",
"ProductNDC": "59088-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Boostervite",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "FERROUS FUMARATE; PANTOTHENIC ACID; ORANGE JUICE; BIOTIN; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; THIAMINE MONONITRATE; PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; BROCCOLI SPROUT; PRUNUS CERASUS (BITTER CHERRY) FRUIT EXTRACT; KALE; WITHANIA SOMNIFERA ROOT",
"StrengthNumber": "18; 50; 2.5; 300; 10; 10; 100; 1000; 100; 10; 10; 10; 2.5; 2.5; 2.5; 60",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260619",
"SamplePackage": "N",
"IndicationAndUsage": "Boostervite contains a combination of vitamins, minerals, and botanical extracts intended to supplement nutritional intake in patients with low energy associated with nutritional needs, under the supervision of a healthcare provider.",
"Description": "Each Tablet Contains. Vitamin C (as ascorbic acid)……………….……………… 100 mg Vitamin D3 (as cholecalciferol)…………….……. 10 mcg (400 IU) Thiamin (as thiamine mononitrate)…………...……………. 10 mg Riboflavin ...................…………………………...………….. 10 mg Niacin (as niacinamide)…………………………....…………10 mg Vitamin B6 (as pyridoxine hydrochloride)………….……….10 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as methylcobalamin)………………….….... 100 mcg Biotin (as d-Biotin)……………………...…….................... 300 mcg Pantothenic Acid (as d-Calcium Pantothenate)………....… 50 mg Iron (as Ferrous Fumarate)……………………………......... 18 mg Withania somnifera (Ashwagandha) Root Powder….....…. 60 mg Brassica oleracea acephala (Kale) Powder……….…...…. 2.5 mg Brassica oleracea italica (Broccoli) Sprout Powder..…...... 2.5 mg Citrus sinensis (Orange) Juice Powder……....................... 2.5 mg Prunus cerasus (Tart Cherry) Extract................................. 2.5 mg. Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (vegetable source), Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol 400, Organic Maltodextrin, Organic Sunflower Lecithin, Organic Sunflower Oil, Organic Guar Gum)."
},
{
"NDCCode": "59088-062-00",
"PackageDescription": "1 KIT in 1 PACKAGE (59088-062-00) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET in 1 BOTTLE, PLASTIC (53746-253-60) * 1 BOTTLE, PUMP in 1 KIT > 237 mL in 1 BOTTLE, PUMP (59088-310-16) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06)",
"NDC11Code": "59088-0062-00",
"ProductNDC": "59088-062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Inflammatral Pak",
"NonProprietaryName": "Diclofenac Sodium Delayed Release Tablets, Ranitidine Tablets, Capsaicin Cream",
"DosageFormName": "KIT",
"StartMarketingDate": "20150612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077863",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-03-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
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<NDCList>
<NDC>
<NDCCode>59088-180-58</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (59088-180-58) </PackageDescription>
<NDC11Code>59088-0180-58</NDC11Code>
<ProductNDC>59088-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zintrexyl-c</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210211</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 30; 1; .75; 37.5; 25; 24.5; 25</StrengthNumber>
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<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zintrexyl-C TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Full Prescribing Information. Each Serving Size of 2 caplets contain. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).</Description>
</NDC>
<NDC>
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<PackageDescription>6 BLISTER PACK in 1 CARTON (59088-096-58) > 1 KIT in 1 BLISTER PACK * 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59088-0096-58</NDC11Code>
<ProductNDC>59088-096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatal, Dha</ProprietaryName>
<NonProprietaryName>Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Ascorbic Acid, Niacin, Folic Acid, Ferrous Fumarate, Calcium Carbonate, Cholecalciferol, Vitamin E Acetate, Potassium Iodide, Zinc Oxide, Choline Bitartrate, And Doconexent</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170810</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-181-58</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (59088-181-58) </PackageDescription>
<NDC11Code>59088-0181-58</NDC11Code>
<ProductNDC>59088-181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folitin-z</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210211</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 30; 1; .75; 37.5; 25; 24.5; 25</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folitin-Z TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occurs together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Full Prescribing Information. Each Serving Size of 2 caplets contain. Vitamin A (as Retinyl Acetate)................................................... 3000 mcg RAE Vitamin C (as Ascorbic Acid)............................................................... 500 mg Vitamin D (as Cholecalciferol).......................................... 3 27.5 mcg (1100 IU) Vitamin E (as DL-alpha Tocopheryl Acetate)........................................... 90 mg Thiamin (as Thiamine Mononitrate)....................................................... 6.5 mg Riboflavin ............................................................................................. 6.7 mg Niacin (as Niacinamide)......................................................................... 45 mg Vitamin B6 (as Pyridoxine HCl)............................................................... 12 mg. Folate 1700 mcg DFE. (as L-5-Methyltetrahydrofolate calcium salt).........(1000 mcg as L-Methyfolate). Vitamin B12 (as Methylcobalamin)....................................................... 26 mcg Biotin ................................................................................................ 200 mcg Pantothenic Acid (as Calcium Pantothenate)........................................... 30 mg Calcium (as Calcium Carbonate)...........................................................150 mg Iron (as Ferrous Fumarate)......................................................................18 mg Iodine (as Potassium Iodide)................................................................50 mcg Magnesium (as Magnesium Oxide)........................................................ 75 mg Zinc (as Zinc Gluconate)......................................................................... 30 mg Selenium (as Selenomethionine)...........................................................60 mcg Copper (as Copper Oxide)....................................................................... 2 mg Manganese (as Manganese Sulfate).......................................................1.5 mg Chromium (as Chromium Polynicotinate)..............................................75 mcg Molybdenum (as Sodium Molybdate)................................................... 50 mcg Potassium (as Potassium Chloride)....................................................... 49 mg Boron (as Boron Citrate)...................................................................... 50 mcg. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).</Description>
</NDC>
<NDC>
<NDCCode>59088-182-58</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (59088-182-58) </PackageDescription>
<NDC11Code>59088-0182-58</NDC11Code>
<ProductNDC>59088-182</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ribotin-e</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210211</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 30; 1; .75; 37.5; 25; 24.5; 25</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ribotin-E TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Full Prescribing Information. Each Serving Size of 2 caplets contain. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).</Description>
</NDC>
<NDC>
<NDCCode>59088-480-58</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (59088-480-58) </PackageDescription>
<NDC11Code>59088-0480-58</NDC11Code>
<ProductNDC>59088-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foliflex</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211025</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 250; 13.75; 45; 3.25; 3.35; 22.5; 6; 500; 13; 100; 15; 75; 9; 25; 37.5; 15; 30; 1; .75; 37.5; 25; 24.5; 25</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Foliflex TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Full Prescribing Information. Each Serving Size of 2 caplets contain. Vitamin A (as Retinyl Acetate) 3000 mcg RAE Vitamin C (as Ascorbic Acid) 500 mg Vitamin D3 (as Cholecalciferol) 27.5 mcg (1100 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) 90 mg Thiamin (as Thiamine Mononitrate) 6.5 mg Riboflavin 6.7 mg Niacin (as Niacinamide) 45 mg Vitamin B6 (as Pyridoxine HCl) 12 mg Folate 1700 mcg DFE (as L-5-Methyltetrahydrofolate calcium salt) (1000 mcg as L-Methyfolate) Vitamin B12 (as Methylcobalamin) 26 mcg Biotin 200 mcg Pantothenic Acid (as Calcium Pantothenate) 30 mg Calcium (as Calcium Carbonate) 150 mg Iron (as Ferrous Fumarate) 18 mg Iodine (as Potassium Iodide) 50 mcg Magnesium (as Magnesium Oxide) 75 mg Zinc (as Zinc Gluconate) 30 mg Selenium (as Selenomethionine) 60 mcg Copper (as Copper Oxide) 2 mg Manganese (as Manganese Sulfate) 1.5 mg Chromium (as Chromium Polynicotinate) 75 mcg Molybdenum (as Sodium Molybdate) 50 mcg Potassium (as Potassium Chloride) 49 mg Boron (as Boron Citrate) 50 mcg. Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).</Description>
</NDC>
<NDC>
<NDCCode>0172-4960-58</NDCCode>
<PackageDescription>180 CAPSULE in 1 BOTTLE (0172-4960-58)</PackageDescription>
<NDC11Code>00172-4960-58</NDC11Code>
<ProductNDC>0172-4960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flutamide</ProprietaryName>
<NonProprietaryName>Flutamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010919</StartMarketingDate>
<EndMarketingDate>20180531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075780</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>FLUTAMIDE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-06-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>11527-180-58</NDCCode>
<PackageDescription>119 g in 1 TUBE (11527-180-58) </PackageDescription>
<NDC11Code>11527-0180-58</NDC11Code>
<ProductNDC>11527-180</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tanners Tasty Vanilla Bling</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120710</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Sheffield Pharmaceuticals LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.43</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aids in the prevention of dental decay.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16729-180-58</NDCCode>
<PackageDescription>300 TABLET in 1 BOTTLE (16729-180-58)</PackageDescription>
<NDC11Code>16729-0180-58</NDC11Code>
<ProductNDC>16729-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202553</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>69816-680-06</NDCCode>
<PackageDescription>1 KIT in 1 BOX (69816-680-06) * 6 g in 1 JAR (69816-180-01) * 58.8 g in 1 JAR (69816-100-01)</PackageDescription>
<NDC11Code>69816-0680-06</NDC11Code>
<ProductNDC>69816-680</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ibuprofen 10 Percent Topical</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150727</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>MaxPac, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71160-180-58</NDCCode>
<PackageDescription>58 mL in 1 BOTTLE (71160-180-58) </PackageDescription>
<NDC11Code>71160-0180-58</NDC11Code>
<ProductNDC>71160-180</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>TEKWELD SOLUTIONS, INC.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>620</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79846-101-58</NDCCode>
<PackageDescription>180 CLOTH in 1 PAIL (79846-101-58) </PackageDescription>
<NDC11Code>79846-0101-58</NDC11Code>
<ProductNDC>79846-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Disinfectant Wipes (75% Alcohol)</ProprietaryName>
<NonProprietaryName>Ethanol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200727</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Jintu Handicraft Factory</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mL/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Unfold towelette, wipe hands, discard after use. Rub thoroughly into hands for at least 30 seconds, allow to dry.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79846-151-58</NDCCode>
<PackageDescription>180 CLOTH in 1 PAIL (79846-151-58) </PackageDescription>
<NDC11Code>79846-0151-58</NDC11Code>
<ProductNDC>79846-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Sanitizing Wipes (0.13% Benzalkonium Chloride)</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200727</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Jintu Handicraft Factory</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>5.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Unfold towelette, wipe hands, discard after use. Rub thoroughly into hands for at least 30 seconds, allow to dry.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-107-58</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (36800-107-58) > 40 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>36800-0107-58</NDC11Code>
<ProductNDC>36800-107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Allergy Relief</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-26</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>46122-040-58</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (46122-040-58) > 40 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>46122-0040-58</NDC11Code>
<ProductNDC>46122-040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy Allergy Relief</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>46122-779-58</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (46122-779-58) / 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46122-0779-58</NDC11Code>
<ProductNDC>46122-779</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091567</ApplicationNumber>
<LabelerName>AMERISOURCE BERGEN</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52959-689-08</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (52959-689-08)</PackageDescription>
<NDC11Code>52959-0689-08</NDC11Code>
<ProductNDC>52959-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076286</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tizanidine tablets are a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Tizanidine hydrochloride USP, is a centrally acting α2-adrenergic agonist. Tizanidine HCl USP (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine’s molecular formula is C9H8ClN5S.HCl, its molecular weight is 290.2 and its structural formula is. Tizanidine tablets USP, is supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets USP, are composed of the active ingredient, tizanidine hydrochloride USP (2.29 mg equivalent to 2 mg tizanidine base and 4.58 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, microcrystalline cellulose, colloidal silicon dioxide and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>62207-766-58</NDCCode>
<PackageDescription>7 BLISTER PACK in 1 CARTON (62207-766-58) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62207-0766-58</NDC11Code>
<ProductNDC>62207-766</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211075</ApplicationNumber>
<LabelerName>Granules India Ltd</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62207-891-58</NDCCode>
<PackageDescription>7 BLISTER PACK in 1 CARTON (62207-891-58) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62207-0891-58</NDC11Code>
<ProductNDC>62207-891</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211075</ApplicationNumber>
<LabelerName>Granules India Limited</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-003-81</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE, PLASTIC (59088-003-81) </PackageDescription>
<NDC11Code>59088-0003-81</NDC11Code>
<ProductNDC>59088-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bruselix Bruising</ProprietaryName>
<NonProprietaryName>Vitamin C, Zinc, Arnica Montana Extract, Bromelain, Diosmin, Rutin, Citrus Bioflavonoids, Hesperidin Methyl Chalcone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241011</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>ARNICA MONTANA FLOWER; STEM BROMELAIN; SODIUM ASCORBATE; HESPERIDIN METHYLCHALCONE; RUTIN; DIOSMIN; HESPERIDIN; ZINC PICOLINATE</SubstanceName>
<StrengthNumber>50; 400; 120; 25; 50; 200; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bruselix Bruising Tablets are formulated to provide nutritional support during the body’s natural recovery process. They may be helpful for individuals experiencing bruising due to minor injuries, surgical procedures, or sensitive skin. The formula contains antioxidants, enzymes, and natural extracts that are traditionally used to support overall skin health and recovery.</IndicationAndUsage>
<Description>Active Ingredients Each tablet contains: Vitamin C (as Sodium Ascorbate) ...............................................................120 mg Zinc (as Zinc Picolinate) ...............................................................................10 mg Arnica Montana Extract 10:1 (equivalent to 500 mg Arnica Montana Powder) ...50 mg Bromelain 2400 GDU/g (from Pineapple) ...................................................400 mg Diosmin (Citrus Aurantium) Fruit Extract.....................................................200 mg Rutin (Sophora Japonica) Flower Extract......................................................50 mg Citrus Bioflavonoids (from pulp and peel of lemon, orange, quince) ............25 mg Hesperidin Methyl Chalcone..........................................................................25 mg. Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (Vegetable Source), Coating (Hydroxypropyl Methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-005-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-005-54) </PackageDescription>
<NDC11Code>59088-0005-54</NDC11Code>
<ProductNDC>59088-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multitol-m</ProprietaryName>
<NonProprietaryName>Multivitamin, Folate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>13.5; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 2040; 8; 200; 1500; 3; 25; 2.3</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Multitol-M is indicated to provide vitamins and minerals supplement to men and women. Folate is effective in the treatment of megaloblastic anemias due to a deficiency of folate (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as Retinyl Acetate)………………........ 1500 mcg RAE Vitamin C (as Ascorbic Acid) .………………..………...… 120 mg Vitamin D3 (As Cholecalciferol) ..……………….. 20 mcg (800 IU) Vitamin E (DL-alpha Tocopheryl Acetate) .……………….. 13.5 mg Thiamin (As Thiamine Mononitrate) …….………………..… 3 mg Riboflavin …………………………….….…..………….... 3.4 mg Niacin (as Niacinamide)…………………………………… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride)…………………. 20 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)………………………….. 8 mcg Calcium (as Calcium Carbonate)…………………………. 200 mg Magnesium (as Magnesium Oxide)……………………… 200 mg Zinc (as Zinc Oxide)……………………………………….. 25 mg Selenium (as Selenium Amino Acid Chelate)……………. 55 mcg Manganese (as Manganese Sulfate)……………………… 2.3 mg Chromium (as Chromium Polynicotinate)……………….. 35 mcg Molybdenum (as Molybdenum Amino Acid Chelate).……. 45 mcg Other Ingredients: Organic Cocoa Powder, Croscarmellose Sodium, Crospovidone, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid. Coating: (Hydroxypropyl Methylcellulose [HPMC], PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-008-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-008-54) </PackageDescription>
<NDC11Code>59088-0008-54</NDC11Code>
<ProductNDC>59088-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finazol</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241011</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC CITRATE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 200; 10; 45; 3.25; 3.35; 22.5; 6; 1000; 26; 100; 15; 100; 18; 25; 50; 30; 30; 1; .75; 37.5; 25; 24.5; 25</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [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], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Finazol is indicated for iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also, for conditions in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Full Prescribing Information: DESCRIPTION: Active Ingredients: Each caplet contains: Vitamin A (as Retinyl Acetate) ……………………………….....1500 mcg RAE Vitamin C (as Ascorbic Acid) ….…..….…………………….……….....200 mg Vitamin D3 (as Cholecalciferol) ….…………………………....10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) ………………………….....45 mg Thiamin (as Thiamine Mononitrate) …..…..…………………………...3.25 mg Riboflavin (as Vitamin B2) …..…..…..…..………………………….…3.35 mg Niacin (as Niacinamide)……………………………………………..…22.5 mg Vitamin B6 (as Pyridoxine HCl)……………………………………………6 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …………………1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)……………………………………..26 mcg Biotin………………………………………………………………….100 mcg Pantothenic Acid (as Calcium Pantothenate)………………………….....15 mg Calcium (as Calcium Carbonate)………………………………………..100 mg Iron (as Ferrous Fumarate)……………………………………………....18 mg Iodine (as Potassium Iodide)…………………………………………...25 mcg Magnesium (as Magnesium Oxide)……………………………………...50 mg Zinc (as Zinc Citrate)……………………………………………………..30 mg Selenium (as Selenomethionine)….…………………………………….30 mcg Copper (as Copper Oxide)………………………………………………....1 mg Manganese (as Manganese Sulfate)…………………………………...0.75 mg Chromium (as Chromium Polynicotinate)…………………………….37.5 mcg Molybdenum (as Sodium Molybdate)…………………………………..25 mcg Potassium (as Potassium Chloride) ……………………………….…..24.5 mg Boron (as Boron Citrate)……………………………………..…………25 mcg. Other Ingredients: Crospovidone, Dextrin, Dextrose Monohydrate, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Purified Stearic Acid, Silicon Dioxide, Sodium Carboxymethylcellulose, Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59088-009-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (59088-009-54) </PackageDescription>
<NDC11Code>59088-0009-54</NDC11Code>
<ProductNDC>59088-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatol-m</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240506</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHOLECALCIFEROL; FERROUS FUMARATE; MOLYBDENUM; ASCORBIC ACID; ZINC OXIDE; CHOLINE BITARTRATE; RIBOFLAVIN; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; VITAMIN A ACETATE; SELENIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CALCIUM CARBONATE; CHROMIUM NICOTINATE; MANGANESE SULFATE; POTASSIUM IODIDE; METHYLCOBALAMIN; LEVOMEFOLATE CALCIUM; THIAMINE MONONITRATE</SubstanceName>
<StrengthNumber>20; 27; 50; 120; 25; 55; 3.4; 200; 13.5; 1500; 70; 20; 50; 200; 45; 2.6; 150; 10; 2040; 3</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications and Usage: Prenatol-M is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatol-M may be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>Each caplet contains: Vitamin A (as Retinyl Acetate) ………………....… 1500 mcg RAE Vitamin C (as Ascorbic Acid) ………………….………… 120 mg Vitamin D3 (as Cholecalciferol).……………....... 20 mcg (800 IU) Vitamin E (as Dl-Alpha Tocopheryl Acetate) ….......….…. 13.5 mg Thiamin (as Thiamine Mononitrate) …………...…………… 3 mg Riboflavin ……………………….…………………….…. 3.4 mg Niacin (as Niacinamide) ………………..……………….… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride) …....…………... 50 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) ….... 2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin) ……….……………... 10 mcg Choline (as Choline Bitartrate) …….……………………… 55 mg Calcium (as Calcium Carbonate) ……...…………………. 200 mg Iron (as Ferrous Fumarate) ………..……………………… 27 mg Iodine (as Potassium Iodine) …...……………………….150 mcg Magnesium (as Magnesium Oxide) …...………………… 200 mg Zinc (as Zinc Oxide) ………………...…………………….. 25 mg Selenium (as Selenium Amino Acid Chelate) ……………. 70 mcg Manganese (as Manganese Sulfate) ……………………… 2.6 mg Chromium (as Chromium Polynicotinate) ……………….. 45 mcg Molybdenum (as Molybdenum Amino Acid Chelate)…...… 50 mcg.</Description>
</NDC>
<NDC>
<NDCCode>59088-013-06</NDCCode>
<PackageDescription>60 g in 1 JAR (59088-013-06) </PackageDescription>
<NDC11Code>59088-0013-06</NDC11Code>
<ProductNDC>59088-013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Methylten</ProprietaryName>
<NonProprietaryName>Methyl Salicylate 10%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250113</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-014-06</NDCCode>
<PackageDescription>60 g in 1 JAR (59088-014-06) </PackageDescription>
<NDC11Code>59088-0014-06</NDC11Code>
<ProductNDC>59088-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Methyl Salicylate 25%</ProprietaryName>
<ProprietaryNameSuffix>Pain Relieving</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250612</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-015-54</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-015-54) </PackageDescription>
<NDC11Code>59088-0015-54</NDC11Code>
<ProductNDC>59088-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flotrex</ProprietaryName>
<NonProprietaryName>Multivitamins, Sodium Fluoride 0.5 Mg</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250221</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.5; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.</IndicationAndUsage>
<Description>Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid)....................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 0.5 mg. Flotrex Multivitamin Chewable plus 0.5 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.5 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.</Description>
</NDC>
<NDC>
<NDCCode>59088-017-54</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-017-54) </PackageDescription>
<NDC11Code>59088-0017-54</NDC11Code>
<ProductNDC>59088-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flotrex</ProprietaryName>
<NonProprietaryName>Multivitamins, Sodium Fluoride 0.25 Mg</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250319</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.25; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.</IndicationAndUsage>
<Description>Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid) ...................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ................................................................... 0.25 mg. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Stearic Acid (vegetable source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.</Description>
</NDC>
<NDC>
<NDCCode>59088-018-54</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-018-54) </PackageDescription>
<NDC11Code>59088-0018-54</NDC11Code>
<ProductNDC>59088-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multivitamin</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN</SubstanceName>
<StrengthNumber>750; 24; 36; 10; 10; 1.05; 1.05; 1.2; 13.5; 1000; 4.5</StrengthNumber>
<StrengthUnit>ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Multivitamin Chewable Tablets is indicated to provide significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.</IndicationAndUsage>
<Description>Vitamin A (as Retinyl Acetate).................................... 750 mcg RAE. Vitamin C (as Sodium Ascorbate and Ascorbic Acid).............. 60 mg. Vitamin D3 (as Cholecalciferol)............................................ 10 mcg. Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 10 mg. Thiamin (as Thiamine Mononitrate).................................... 1.05 mg. Riboflavin............................................................................... 1.2 mg. Niacin (as Niacinamide)....................................................... 13.5 mg. Vitamin B6 (as Pyridoxine Hydrochloride).......................... 1.05 mg. Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE. (1000 mcg as L-5-Methylfolate). Vitamin B12 (as Methylcobalamin)..................................... 4.5 mcg.</Description>
</NDC>
<NDC>
<NDCCode>59088-020-54</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-020-54) </PackageDescription>
<NDC11Code>59088-0020-54</NDC11Code>
<ProductNDC>59088-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flotrex</ProprietaryName>
<NonProprietaryName>Multivitamins, Sodium Fluoride 1 Mg</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250710</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.</IndicationAndUsage>
<Description>Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid)....................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 1 mg. Flotrex Multivitamin Chewable plus 1 mg Fluoride Tablets Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 1 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.</Description>
</NDC>
<NDC>
<NDCCode>59088-022-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-022-54) </PackageDescription>
<NDC11Code>59088-0022-54</NDC11Code>
<ProductNDC>59088-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Boostervite</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260619</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; PANTOTHENIC ACID; ORANGE JUICE; BIOTIN; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; THIAMINE MONONITRATE; PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; BROCCOLI SPROUT; PRUNUS CERASUS (BITTER CHERRY) FRUIT EXTRACT; KALE; WITHANIA SOMNIFERA ROOT</SubstanceName>
<StrengthNumber>18; 50; 2.5; 300; 10; 10; 100; 1000; 100; 10; 10; 10; 2.5; 2.5; 2.5; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Boostervite contains a combination of vitamins, minerals, and botanical extracts intended to supplement nutritional intake in patients with low energy associated with nutritional needs, under the supervision of a healthcare provider.</IndicationAndUsage>
<Description>Each Tablet Contains. Vitamin C (as ascorbic acid)……………….……………… 100 mg Vitamin D3 (as cholecalciferol)…………….……. 10 mcg (400 IU) Thiamin (as thiamine mononitrate)…………...……………. 10 mg Riboflavin ...................…………………………...………….. 10 mg Niacin (as niacinamide)…………………………....…………10 mg Vitamin B6 (as pyridoxine hydrochloride)………….……….10 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as methylcobalamin)………………….….... 100 mcg Biotin (as d-Biotin)……………………...…….................... 300 mcg Pantothenic Acid (as d-Calcium Pantothenate)………....… 50 mg Iron (as Ferrous Fumarate)……………………………......... 18 mg Withania somnifera (Ashwagandha) Root Powder….....…. 60 mg Brassica oleracea acephala (Kale) Powder……….…...…. 2.5 mg Brassica oleracea italica (Broccoli) Sprout Powder..…...... 2.5 mg Citrus sinensis (Orange) Juice Powder……....................... 2.5 mg Prunus cerasus (Tart Cherry) Extract................................. 2.5 mg. Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (vegetable source), Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol 400, Organic Maltodextrin, Organic Sunflower Lecithin, Organic Sunflower Oil, Organic Guar Gum).</Description>
</NDC>
<NDC>
<NDCCode>59088-062-00</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (59088-062-00) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET in 1 BOTTLE, PLASTIC (53746-253-60) * 1 BOTTLE, PUMP in 1 KIT > 237 mL in 1 BOTTLE, PUMP (59088-310-16) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06)</PackageDescription>
<NDC11Code>59088-0062-00</NDC11Code>
<ProductNDC>59088-062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacinrx Inflammatral Pak</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium Delayed Release Tablets, Ranitidine Tablets, Capsaicin Cream</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077863</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-03-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>