{
"NDC": [
{
"NDCCode": "63044-203-61",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63044-203-61) > 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "63044-0203-61",
"ProductNDC": "63044-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iferex 150",
"NonProprietaryName": "Polysaccharide-iron Complex",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071028",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "IRON",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-04-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63044-203-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (63044-203-01)",
"NDC11Code": "63044-0203-01",
"ProductNDC": "63044-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iferex 150",
"NonProprietaryName": "Polysaccharide-iron Complex",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071028",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "IRON",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-04-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49230-203-61",
"PackageDescription": "2 BAG in 1 CARTON (49230-203-61) > 6000 mL in 1 BAG",
"NDC11Code": "49230-0203-61",
"ProductNDC": "49230-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delflex",
"ProprietaryNameSuffix": "Neutral Ph",
"NonProprietaryName": "Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "19841130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018883",
"LabelerName": "Fresenius Medical Care North America",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "4.25; 538; 409; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-07-17",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "73194-203-61",
"PackageDescription": "236 mL in 1 BOTTLE (73194-203-61) ",
"NDC11Code": "73194-0203-61",
"ProductNDC": "73194-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acmeros Personal Lubricant",
"NonProprietaryName": "Personal Lubricant",
"DosageFormName": "OIL",
"RouteName": "CUTANEOUS; EXTRACORPOREAL; TOPICAL; VAGINAL",
"StartMarketingDate": "20191015",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Shenzhen Yuqintang Shengwu Jishu Co., Ltd.",
"SubstanceName": "BUTYLENE GLYCOL",
"StrengthNumber": "47.2",
"StrengthUnit": "g/236mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20191015",
"SamplePackage": "N"
},
{
"NDCCode": "69842-203-06",
"PackageDescription": "6 PATCH in 1 PACKAGE (69842-203-06) ",
"NDC11Code": "69842-0203-06",
"ProductNDC": "69842-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "One Step Corn Remover",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180731",
"EndMarketingDate": "20231231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M030",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "40",
"StrengthUnit": "mg/61",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180731",
"EndMarketingDatePackage": "20231231",
"SamplePackage": "N"
},
{
"NDCCode": "63044-030-60",
"PackageDescription": "56.6 g in 1 TUBE (63044-030-60) ",
"NDC11Code": "63044-0030-60",
"ProductNDC": "63044-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ziks Arthritis Pain Relief",
"NonProprietaryName": "Ziks Arthritis Pain Relief",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19991110",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "METHYL SALICYLATE; MENTHOL; CAPSAICIN",
"StrengthNumber": "6.79; .566; .014",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19991110",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pain of muscles and joints associated with arthritis, simple backache, strains and sprains. *Products containing purified capsaicin are most recommended by doctors and pharmacists.",
"Description": "Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician. A passing burning sensation may occur upon application, but generally disappears in several days. Application schedules of less than 3 to 4 times a day may not provide optimum pain relief ant the burning sensation may persist. WASH HANDS WITH SOAP AND WATER AFTER APPLYING UNLESS TREATING HANDS."
},
{
"NDCCode": "63044-150-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (63044-150-01) ",
"NDC11Code": "63044-0150-01",
"ProductNDC": "63044-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatal Vitamins Plus",
"NonProprietaryName": "Vitamin A, Vitamin C, Vitamin D-3, Vitamin E, Vitamin B-1, Vitamin B-2, Niacin, Vitamin B-6, Calcium, Iron, Zinc, Copper",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160225",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE",
"StrengthNumber": "10; 120; 200; 10; 2; 12; 27; 1700; 20; 10; 3; 1.84; 1200; 25",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Inhibit Ovum Fertilization [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": "Deprecated",
"LastUpdate": "2022-12-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160225",
"SamplePackage": "N"
},
{
"NDCCode": "63044-150-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (63044-150-05) ",
"NDC11Code": "63044-0150-05",
"ProductNDC": "63044-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatal Vitamins Plus",
"NonProprietaryName": "Vitamin A, Vitamin C, Vitamin D-3, Vitamin E, Vitamin B-1, Vitamin B-2, Niacin, Vitamin B-6, Calcium, Iron, Zinc, Copper",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160225",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE",
"StrengthNumber": "10; 120; 200; 10; 2; 12; 27; 1700; 20; 10; 3; 1.84; 1200; 25",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Inhibit Ovum Fertilization [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": "Deprecated",
"LastUpdate": "2022-12-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160225",
"SamplePackage": "N"
},
{
"NDCCode": "63044-153-01",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE (63044-153-01)",
"NDC11Code": "63044-0153-01",
"ProductNDC": "63044-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inatal Advance",
"NonProprietaryName": "Inatal Advance",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050610",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; CALCIUM CARBONATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; ZINC OXIDE; CUPRIC OXIDE; MAGNESIUM OXIDE; DOCUSATE SODIUM",
"StrengthNumber": "2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 25; 2; 30; 50",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "INATAL ADVANCE ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. INATAL Advanced® can also be beneficial in improving the nutritional status of women prior to conception.",
"Description": "INATAL Advanced ® is a white, dye-free, oval shaped, oil-and-water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. Each tablet contains. Vitamin A (as beta-carotene) . . . . . . . . . . . 2700 I.U. Vitamin C (ascorbic acid) . . . . . . . . . . . . . . 120 mg. Calcium (as calcium carbonate) . . . . . . . . . . 200 mg. Elemental Iron (as carbonyl iron) . . . . . . . . . . 90 mg. Vitamin D3 (cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-alpha tocopheryl acetate) . . . . . 30 I.U. Vitamin B1 (as thiamine mononitrate) . . . . . . . . 3 mg. Vitamin B2 (riboflavin, USP) . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (as pyridoxine HCI, USP) . . . . . . . 20 mg. Folic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (cyanocobalamin) . . . . . . . . . . . 12 mcg. Zinc (as zinc oxide, USP) . . . . . . . . . . . . . . . . 25 mg. Copper (as cupric oxide) . . . . . . . . . . . . . . . . . 2 mg. Magnesium (as magnesium oxide, USP) . . . . . 30 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. INACTIVE INGREDIENTS: Carnauba wax, crospovidone, ethyl vanillin, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, silicon dioxide, stearic acid, and titanium dioxide."
},
{
"NDCCode": "63044-153-64",
"PackageDescription": "9 BLISTER PACK in 1 BOX, UNIT-DOSE (63044-153-64) > 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "63044-0153-64",
"ProductNDC": "63044-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inatal Advance",
"NonProprietaryName": "Inatal Advance",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050610",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; CALCIUM CARBONATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; ZINC OXIDE; CUPRIC OXIDE; MAGNESIUM OXIDE; DOCUSATE SODIUM",
"StrengthNumber": "2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 25; 2; 30; 50",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "INATAL ADVANCE ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. INATAL Advanced® can also be beneficial in improving the nutritional status of women prior to conception.",
"Description": "INATAL Advanced ® is a white, dye-free, oval shaped, oil-and-water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. Each tablet contains. Vitamin A (as beta-carotene) . . . . . . . . . . . 2700 I.U. Vitamin C (ascorbic acid) . . . . . . . . . . . . . . 120 mg. Calcium (as calcium carbonate) . . . . . . . . . . 200 mg. Elemental Iron (as carbonyl iron) . . . . . . . . . . 90 mg. Vitamin D3 (cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-alpha tocopheryl acetate) . . . . . 30 I.U. Vitamin B1 (as thiamine mononitrate) . . . . . . . . 3 mg. Vitamin B2 (riboflavin, USP) . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (as pyridoxine HCI, USP) . . . . . . . 20 mg. Folic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (cyanocobalamin) . . . . . . . . . . . 12 mcg. Zinc (as zinc oxide, USP) . . . . . . . . . . . . . . . . 25 mg. Copper (as cupric oxide) . . . . . . . . . . . . . . . . . 2 mg. Magnesium (as magnesium oxide, USP) . . . . . 30 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. INACTIVE INGREDIENTS: Carnauba wax, crospovidone, ethyl vanillin, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, silicon dioxide, stearic acid, and titanium dioxide."
},
{
"NDCCode": "63044-154-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (63044-154-01)",
"NDC11Code": "63044-0154-01",
"ProductNDC": "63044-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inatal Ultra",
"NonProprietaryName": "Inatal Ultra",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050620",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; POTASSIUM IODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM",
"StrengthNumber": "2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 150; 25; 2; 50",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "INATAL Ultra ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Ultra NatalCare® can also be beneficial in improving the nutritional status of women prior to conception.",
"Description": "INATAL Ultra is a white, dye free, oval oil-and-water-soluble multivitamin/multimineral tablet with calcium citrate and carbonyl iron. Each tablet contains. Vitamin A* . . . . . . . . . . . . . . . . . . . . . . . 2700 I.U. Vitamin C (Ascorbic Acid) . . . . . . . . . . . . . . 120 mg. Calcium (Calcium Citrate) . . . . . . . . . . . . . 200 mg. Elemental Iron (Carbonyl Iron) . . . . . . . . . . . 90 mg. Vitamin D3 (Cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-Alpha Tocopheryl Acetate) . . . . . 30 I.U. Vitamin B1 (Thiamine Mononitrate) . . . . . . . . . 3 mg. Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (Pyridoxine HCI) . . . . . . . . . . . . . 20 mg. Folic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (Cyanocobalamin) . . . . . . . . . . 12 mcg. Iodine (Potassium Iodide) . . . . . . . . . . . . . 150 mcg. Zinc (Zinc Oxide) . . . . . . . . . . . . . . . . . . . . . 25 mg. Copper (Cupric Oxide) . . . . . . . . . . . . . . . . . 2 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. *Input as Vitamin A palmitate and beta carotene."
},
{
"NDCCode": "63044-154-63",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63044-154-63) > 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "63044-0154-63",
"ProductNDC": "63044-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inatal Ultra",
"NonProprietaryName": "Inatal Ultra",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050620",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; POTASSIUM IODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM",
"StrengthNumber": "2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 150; 25; 2; 50",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "INATAL Ultra ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Ultra NatalCare® can also be beneficial in improving the nutritional status of women prior to conception.",
"Description": "INATAL Ultra is a white, dye free, oval oil-and-water-soluble multivitamin/multimineral tablet with calcium citrate and carbonyl iron. Each tablet contains. Vitamin A* . . . . . . . . . . . . . . . . . . . . . . . 2700 I.U. Vitamin C (Ascorbic Acid) . . . . . . . . . . . . . . 120 mg. Calcium (Calcium Citrate) . . . . . . . . . . . . . 200 mg. Elemental Iron (Carbonyl Iron) . . . . . . . . . . . 90 mg. Vitamin D3 (Cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-Alpha Tocopheryl Acetate) . . . . . 30 I.U. Vitamin B1 (Thiamine Mononitrate) . . . . . . . . . 3 mg. Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (Pyridoxine HCI) . . . . . . . . . . . . . 20 mg. Folic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (Cyanocobalamin) . . . . . . . . . . 12 mcg. Iodine (Potassium Iodide) . . . . . . . . . . . . . 150 mcg. Zinc (Zinc Oxide) . . . . . . . . . . . . . . . . . . . . . 25 mg. Copper (Cupric Oxide) . . . . . . . . . . . . . . . . . 2 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. *Input as Vitamin A palmitate and beta carotene."
},
{
"NDCCode": "63044-198-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (63044-198-01)",
"NDC11Code": "63044-0198-01",
"ProductNDC": "63044-198",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iferex 150 Forte",
"NonProprietaryName": "Iron, Cyanocobalamin And Folic Acid",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071028",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "IRON; CYANOCOBALAMIN; FOLIC ACID",
"StrengthNumber": "150; 25; 1",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-04-26",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63044-401-01",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (63044-401-01)",
"NDC11Code": "63044-0401-01",
"ProductNDC": "63044-401",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitamin D3dietary Supplemen",
"ProprietaryNameSuffix": "Dietary Supplement",
"NonProprietaryName": "Cholecalciferol",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120114",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL",
"StrengthNumber": ".25; 5",
"StrengthUnit": "mg/1; [iU]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63044-404-20",
"PackageDescription": "140 g in 1 TUBE (63044-404-20)",
"NDC11Code": "63044-0404-20",
"ProductNDC": "63044-404",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ammonium Lactate",
"NonProprietaryName": "Ammonium Lactate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20071230",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "AMMONIUM LACTATE",
"StrengthNumber": "17",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ammonium Lactate Cream is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.",
"Description": "Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Ingredients: Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light mineral oil, magnesium aluminum silicate, methyl and propyl parabens, Carbomer 940, PEG-100 stearate, polysorbate 85, triethanolamine, propylene glycol, Petrolatum and Sodium PCA, stearic acid and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula."
},
{
"NDCCode": "63044-484-09",
"PackageDescription": "225 g in 1 BOTTLE, PLASTIC (63044-484-09)",
"NDC11Code": "63044-0484-09",
"ProductNDC": "63044-484",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ammonium Lactate",
"NonProprietaryName": "Ammonium Lactate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20071230",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "AMMONIUM LACTATE",
"StrengthNumber": "17",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ammonium Lactate Lotion is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.",
"Description": "Ammonium Lactate Lotion, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Ingredients: Ammonium Lactate Lotion, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light mineral oil, magnesium aluminum silicate, methyl and propyl parabens, Carbomer 940, PEG-100 stearate, polysorbate 85, triethanolamine, propylene glycol, Petrolatum and Sodium PCA, stearic acid and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula."
},
{
"NDCCode": "63044-622-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (63044-622-01) ",
"NDC11Code": "63044-0622-01",
"ProductNDC": "63044-622",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reno Caps",
"NonProprietaryName": "Reno Caps",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20081130",
"EndMarketingDate": "20181130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "ASCORBIC ACID; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; BIOTIN; PANTOTHENIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "100; 1.5; 1.7; 20; 10; 1; 150; 5; 6",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20081130",
"EndMarketingDatePackage": "20181130",
"SamplePackage": "N"
},
{
"NDCCode": "63044-622-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (63044-622-30) ",
"NDC11Code": "63044-0622-30",
"ProductNDC": "63044-622",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reno Caps",
"NonProprietaryName": "Reno Caps",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20081130",
"EndMarketingDate": "20181130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "ASCORBIC ACID; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; BIOTIN; PANTOTHENIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "100; 1.5; 1.7; 20; 10; 1; 150; 5; 6",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20081130",
"EndMarketingDatePackage": "20181130",
"SamplePackage": "N"
},
{
"NDCCode": "63044-622-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (63044-622-90) ",
"NDC11Code": "63044-0622-90",
"ProductNDC": "63044-622",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reno Caps",
"NonProprietaryName": "Reno Caps",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20081130",
"EndMarketingDate": "20181130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "ASCORBIC ACID; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; BIOTIN; PANTOTHENIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "100; 1.5; 1.7; 20; 10; 1; 150; 5; 6",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20081130",
"EndMarketingDatePackage": "20181130",
"SamplePackage": "N"
},
{
"NDCCode": "63044-631-19",
"PackageDescription": "100 BLISTER PACK in 1 BOX (63044-631-19) / 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "63044-0631-19",
"ProductNDC": "63044-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hematogen",
"NonProprietaryName": "Ferrous Fumarate, Ascorbic Acid, Intrinsic Factor , Cyanocobalamin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070510",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; INTRINSIC FACTOR",
"StrengthNumber": "250; 10; 66; 100",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20070510",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence."
},
{
"NDCCode": "63044-632-17",
"PackageDescription": "10 BLISTER PACK in 1 BOX (63044-632-17) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "63044-0632-17",
"ProductNDC": "63044-632",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hematogen Fa",
"NonProprietaryName": "Ferrous Fumarate, Ascorbic Acid, Folic Acid, Cyanocobalamin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID",
"StrengthNumber": "250; 10; 66; 1",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20050101",
"SamplePackage": "N",
"Description": "CONTENTS : Each maroon and brown soft gelatin capsule contains. Ferrous fumarate ........................................................................200 mg. (66 mg elemental iron). Ascorbic acid ..............................................................................250 mg. Folic acid ........................................................................................1 mg. Cyanocobalamin .........................................................................10 mcg. DISCUSSION : The amount of elemental iron and the absorption of the iron components of commercial iron preparations vary widely. It is further established that certain \"accessory components\" may be included to enhance absorption and utilization of iron. Hematogen FA Capsules are formulated to provide the essential factors for a complete, versatile hematinic."
},
{
"NDCCode": "63044-633-21",
"PackageDescription": "10 BLISTER PACK in 1 BOX (63044-633-21) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "63044-0633-21",
"ProductNDC": "63044-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hematogen Forte",
"NonProprietaryName": "Ferrous Fumarate, Ascorbic Acid, Folic Acid, Cyanocobalamin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070510",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID",
"StrengthNumber": "1; 10; 151; 10",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20070510",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence.",
"Description": "Each brown soft gelatin capsule contains. Ferrous fumarate............................................................................ 460 mg. (151 mg elemental iron). Ascorbic acid.................................................................................... 60 mg. Folic acid............................................................................................ 1 mg. Cyanocobalamin.............................................................................10 mcg. The amount of elemental iron and the absorption of the iron components of commercial iron preparations vary widely. It is further established that certain \"accessory components\" may be included to enhance absorption and utilization of iron. Hematogen Forte Capsules are formulated to provide the essential factors for a complete, versatile hematinic. Inactive Ingredients: Soybean oil, Lecithin, Glycerin, hydrogenated soybean oil, Yellow Beewax, Titanium Oxide."
},
{
"NDCCode": "63044-635-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX (63044-635-10) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "63044-0635-10",
"ProductNDC": "63044-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tricon",
"NonProprietaryName": "Tricon",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050520",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "CYANOCOBALAMIN; FERROUS FUMARATE; ASCORBIC ACID; FOLIC ACID",
"StrengthNumber": "15; 110; 75; .5",
"StrengthUnit": "ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050520",
"SamplePackage": "N",
"IndicationAndUsage": "TRICON is a multifactor preparation effective in the treatment of anemias that respond to oral hematinics, including pernicious anemia and other megaloblastic anemias and also irondeficiency anemia. Therapeutic quantities of hematopoietic factors that are known to be important are present in the recommended daily dose.",
"Description": "Each TRICON Capsule contains. Special liver-stomach concentrate. (containing intrinsic factor). . . . . . . . . . . . . . . . 240 mg. Vitamin B12 (activity equivalent) . . . . . . . . . . . .15 mcg. Iron, elemental (ferrous fumarate) . . . . . . . . . .110 mg. Vitamin C (ascorbic acid) . . . . . . . . . . . . . . . . . 75 mg. Folic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 mg. with other factors of vitamin B complex present in the liver-stomach concentrate. Inactive ingredients: Citric acid, D&C Yellow No. 10, ethylcellulose, FD&C Blue No. 1, FD&C Red #28, gelatin, lecithin, magnesium stearate, pharmaceutical glaze, silicon dioxide, simethicone, sodium benzoate, sodium citrate, sorbic acid, starch, and titanium dioxide."
},
{
"NDCCode": "0065-0343-02",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0343-02",
"ProductNDC": "0065-0343",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207926",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.",
"Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%)."
},
{
"NDCCode": "0065-0349-04",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0349-04) / 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0349-04",
"ProductNDC": "0065-0349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207926",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.",
"Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%)."
},
{
"NDCCode": "0065-0349-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0349-05) / 2 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0349-05",
"ProductNDC": "0065-0349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207926",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.",
"Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%)."
},
{
"NDCCode": "0065-0359-02",
"PackageDescription": "2 mL in 1 BOTTLE, PLASTIC (0065-0359-02) ",
"NDC11Code": "00065-0359-02",
"ProductNDC": "0065-0359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclomydril",
"NonProprietaryName": "Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19580630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084300",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "2; 10",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19580630",
"SamplePackage": "N",
"IndicationAndUsage": "For the production of mydriasis.",
"Description": "CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution. The active ingredients are represented by the chemical structures. Established Name:Cyclopentolate Hydrochloride. Chemical Name:2-(Dimethylamino)ethyl 1 - hydroxy-α-phenylcyclopentaneacetate hydrochloride). Molecular Formula:C17H25NO3 HCl. Molecular Weight:327.85 g/mol. Established Name:Phenylephrine Hydrochloride. Chemical Name:3-hydroxy-α[(methylamino)-methyl]-, Benzenemethanol, hydrochloride (R)-. Molecular Formula:C9H13NO2 HCl. Molecular Weight:203.67 g/mol. Each mL of CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) contains:Active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. Preservative: benzalkonium chloride 0.01%.Inactives: edetate disodium, boric acid, hydrochloric acid and /or sodium carbonate (to adjust pH), purified water."
},
{
"NDCCode": "0065-0359-05",
"PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (0065-0359-05) ",
"NDC11Code": "00065-0359-05",
"ProductNDC": "0065-0359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclomydril",
"NonProprietaryName": "Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19580630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084300",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "2; 10",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19580630",
"SamplePackage": "N",
"IndicationAndUsage": "For the production of mydriasis.",
"Description": "CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution. The active ingredients are represented by the chemical structures. Established Name:Cyclopentolate Hydrochloride. Chemical Name:2-(Dimethylamino)ethyl 1 - hydroxy-α-phenylcyclopentaneacetate hydrochloride). Molecular Formula:C17H25NO3 HCl. Molecular Weight:327.85 g/mol. Established Name:Phenylephrine Hydrochloride. Chemical Name:3-hydroxy-α[(methylamino)-methyl]-, Benzenemethanol, hydrochloride (R)-. Molecular Formula:C9H13NO2 HCl. Molecular Weight:203.67 g/mol. Each mL of CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) contains:Active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. Preservative: benzalkonium chloride 0.01%.Inactives: edetate disodium, boric acid, hydrochloric acid and /or sodium carbonate (to adjust pH), purified water."
},
{
"NDCCode": "0121-0925-16",
"PackageDescription": "473 mL in 1 BOTTLE (0121-0925-16) ",
"NDC11Code": "00121-0925-16",
"ProductNDC": "0121-0925",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Vc With Codeine Oral Solution",
"NonProprietaryName": "Promethazine And Phenylephrine Hydrochloride And Codeine Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210318",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040660",
"LabelerName": "PAI Holdings, LLC",
"SubstanceName": "CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "10; 5; 6.25",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210318",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine VC with Codeine Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]. Contraindicated in pediatric patients under 12 years of age [see Contraindications (4) and Use in Specific Populations (8.4)]. Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4) and Use in Specific Populations (8.4)]. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Promethazine VC with Codeine Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks,and in whom an adequate assessment of the etiology of the cough has been made.",
"Description": "Promethazine VC with Codeine Oral Solution (promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate) oral solution contains codeine an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist. Each 5 mL of Promethazine VC with Codeine Oral Solution contains 10 mg of codeine phosphate, 6.25 mg of promethazine hydrochloride, and 5 mg of phenylephrine hydrochloride for oral administration. Promethazine VC with Codeine Oral Solution has a pH between 4.4 and 5.2 and contains alcohol 7%. Promethazine VC with Codeine Oral Solution also contains the following inactive ingredients: Ascorbic acid, citric acid, D&C Red #33, FD&C Yellow #6, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate, strawberry flavor and sucrose. Codeine Phosphate. The chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C 18H 21NO 3H 3PO 4 ½ H 2O, and it has the following chemical structure. Promethazine Hydrochloride. The chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C 17H 20N 2SHCl, and it has the following chemical structure. Phenylephrine Hydrochloride. The chemical name for phenylephrine hydrochloride, a sympathomimetic amine salt, is (-)- m-hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. The molecular weight is 203.67. Its molecular formula is C 9H 13NO 2 HCl, and it has the following chemical structure."
},
{
"NDCCode": "0121-0926-16",
"PackageDescription": "437 mL in 1 BOTTLE (0121-0926-16) ",
"NDC11Code": "00121-0926-16",
"ProductNDC": "0121-0926",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Vc",
"NonProprietaryName": "Promethazine Hydrochloride And Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210311",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040654",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "5; 6.25",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210311",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.",
"Description": "Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg. Alcohol 7%. Inactive Ingredients: Apricot peach flavor, ascorbic acid, citric acid, FD&C yellow #6, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17H 20N 2SHCI, and the following structural formula:. Phenylephrine hydrochloride is a sympathomimetic amine salt which is chemically designated as (-)-m-Hydroxy-α-[(methylamino)methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. It has a molecular weight of 203.67, a molecular formula of C 9H 13NO 2HCI, and the following structural formula:."
}
]
}
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<NDC>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
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<LabelerName>Shenzhen Yuqintang Shengwu Jishu Co., Ltd.</LabelerName>
<SubstanceName>BUTYLENE GLYCOL</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2020-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>One Step Corn Remover</NonProprietaryName>
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<EndMarketingDate>20231231</EndMarketingDate>
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<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/61</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180731</StartMarketingDatePackage>
<EndMarketingDatePackage>20231231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>63044-030-60</NDCCode>
<PackageDescription>56.6 g in 1 TUBE (63044-030-60) </PackageDescription>
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<ProductNDC>63044-030</ProductNDC>
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<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pain of muscles and joints associated with arthritis, simple backache, strains and sprains. *Products containing purified capsaicin are most recommended by doctors and pharmacists.</IndicationAndUsage>
<Description>Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician. A passing burning sensation may occur upon application, but generally disappears in several days. Application schedules of less than 3 to 4 times a day may not provide optimum pain relief ant the burning sensation may persist. WASH HANDS WITH SOAP AND WATER AFTER APPLYING UNLESS TREATING HANDS.</Description>
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<StartMarketingDate>20160225</StartMarketingDate>
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<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>10; 120; 200; 10; 2; 12; 27; 1700; 20; 10; 3; 1.84; 1200; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Inhibit Ovum Fertilization [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>Deprecated</Status>
<LastUpdate>2022-12-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63044-150-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (63044-150-05) </PackageDescription>
<NDC11Code>63044-0150-05</NDC11Code>
<ProductNDC>63044-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatal Vitamins Plus</ProprietaryName>
<NonProprietaryName>Vitamin A, Vitamin C, Vitamin D-3, Vitamin E, Vitamin B-1, Vitamin B-2, Niacin, Vitamin B-6, Calcium, Iron, Zinc, Copper</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160225</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>10; 120; 200; 10; 2; 12; 27; 1700; 20; 10; 3; 1.84; 1200; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Inhibit Ovum Fertilization [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>Deprecated</Status>
<LastUpdate>2022-12-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63044-153-01</NDCCode>
<PackageDescription>90 TABLET, COATED in 1 BOTTLE (63044-153-01)</PackageDescription>
<NDC11Code>63044-0153-01</NDC11Code>
<ProductNDC>63044-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inatal Advance</ProprietaryName>
<NonProprietaryName>Inatal Advance</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CALCIUM CARBONATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; ZINC OXIDE; CUPRIC OXIDE; MAGNESIUM OXIDE; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 25; 2; 30; 50</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INATAL ADVANCE ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. INATAL Advanced® can also be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>INATAL Advanced ® is a white, dye-free, oval shaped, oil-and-water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. Each tablet contains. Vitamin A (as beta-carotene) . . . . . . . . . . . 2700 I.U. Vitamin C (ascorbic acid) . . . . . . . . . . . . . . 120 mg. Calcium (as calcium carbonate) . . . . . . . . . . 200 mg. Elemental Iron (as carbonyl iron) . . . . . . . . . . 90 mg. Vitamin D3 (cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-alpha tocopheryl acetate) . . . . . 30 I.U. Vitamin B1 (as thiamine mononitrate) . . . . . . . . 3 mg. Vitamin B2 (riboflavin, USP) . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (as pyridoxine HCI, USP) . . . . . . . 20 mg. Folic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (cyanocobalamin) . . . . . . . . . . . 12 mcg. Zinc (as zinc oxide, USP) . . . . . . . . . . . . . . . . 25 mg. Copper (as cupric oxide) . . . . . . . . . . . . . . . . . 2 mg. Magnesium (as magnesium oxide, USP) . . . . . 30 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. INACTIVE INGREDIENTS: Carnauba wax, crospovidone, ethyl vanillin, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, silicon dioxide, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63044-153-64</NDCCode>
<PackageDescription>9 BLISTER PACK in 1 BOX, UNIT-DOSE (63044-153-64) > 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63044-0153-64</NDC11Code>
<ProductNDC>63044-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inatal Advance</ProprietaryName>
<NonProprietaryName>Inatal Advance</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CALCIUM CARBONATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; ZINC OXIDE; CUPRIC OXIDE; MAGNESIUM OXIDE; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 25; 2; 30; 50</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INATAL ADVANCE ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. INATAL Advanced® can also be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>INATAL Advanced ® is a white, dye-free, oval shaped, oil-and-water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. Each tablet contains. Vitamin A (as beta-carotene) . . . . . . . . . . . 2700 I.U. Vitamin C (ascorbic acid) . . . . . . . . . . . . . . 120 mg. Calcium (as calcium carbonate) . . . . . . . . . . 200 mg. Elemental Iron (as carbonyl iron) . . . . . . . . . . 90 mg. Vitamin D3 (cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-alpha tocopheryl acetate) . . . . . 30 I.U. Vitamin B1 (as thiamine mononitrate) . . . . . . . . 3 mg. Vitamin B2 (riboflavin, USP) . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (as pyridoxine HCI, USP) . . . . . . . 20 mg. Folic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (cyanocobalamin) . . . . . . . . . . . 12 mcg. Zinc (as zinc oxide, USP) . . . . . . . . . . . . . . . . 25 mg. Copper (as cupric oxide) . . . . . . . . . . . . . . . . . 2 mg. Magnesium (as magnesium oxide, USP) . . . . . 30 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. INACTIVE INGREDIENTS: Carnauba wax, crospovidone, ethyl vanillin, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, silicon dioxide, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63044-154-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (63044-154-01)</PackageDescription>
<NDC11Code>63044-0154-01</NDC11Code>
<ProductNDC>63044-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inatal Ultra</ProprietaryName>
<NonProprietaryName>Inatal Ultra</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050620</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; POTASSIUM IODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 150; 25; 2; 50</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INATAL Ultra ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Ultra NatalCare® can also be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>INATAL Ultra is a white, dye free, oval oil-and-water-soluble multivitamin/multimineral tablet with calcium citrate and carbonyl iron. Each tablet contains. Vitamin A* . . . . . . . . . . . . . . . . . . . . . . . 2700 I.U. Vitamin C (Ascorbic Acid) . . . . . . . . . . . . . . 120 mg. Calcium (Calcium Citrate) . . . . . . . . . . . . . 200 mg. Elemental Iron (Carbonyl Iron) . . . . . . . . . . . 90 mg. Vitamin D3 (Cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-Alpha Tocopheryl Acetate) . . . . . 30 I.U. Vitamin B1 (Thiamine Mononitrate) . . . . . . . . . 3 mg. Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (Pyridoxine HCI) . . . . . . . . . . . . . 20 mg. Folic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (Cyanocobalamin) . . . . . . . . . . 12 mcg. Iodine (Potassium Iodide) . . . . . . . . . . . . . 150 mcg. Zinc (Zinc Oxide) . . . . . . . . . . . . . . . . . . . . . 25 mg. Copper (Cupric Oxide) . . . . . . . . . . . . . . . . . 2 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. *Input as Vitamin A palmitate and beta carotene.</Description>
</NDC>
<NDC>
<NDCCode>63044-154-63</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63044-154-63) > 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63044-0154-63</NDC11Code>
<ProductNDC>63044-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inatal Ultra</ProprietaryName>
<NonProprietaryName>Inatal Ultra</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050620</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; POTASSIUM IODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 150; 25; 2; 50</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INATAL Ultra ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Ultra NatalCare® can also be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>INATAL Ultra is a white, dye free, oval oil-and-water-soluble multivitamin/multimineral tablet with calcium citrate and carbonyl iron. Each tablet contains. Vitamin A* . . . . . . . . . . . . . . . . . . . . . . . 2700 I.U. Vitamin C (Ascorbic Acid) . . . . . . . . . . . . . . 120 mg. Calcium (Calcium Citrate) . . . . . . . . . . . . . 200 mg. Elemental Iron (Carbonyl Iron) . . . . . . . . . . . 90 mg. Vitamin D3 (Cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-Alpha Tocopheryl Acetate) . . . . . 30 I.U. Vitamin B1 (Thiamine Mononitrate) . . . . . . . . . 3 mg. Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (Pyridoxine HCI) . . . . . . . . . . . . . 20 mg. Folic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (Cyanocobalamin) . . . . . . . . . . 12 mcg. Iodine (Potassium Iodide) . . . . . . . . . . . . . 150 mcg. Zinc (Zinc Oxide) . . . . . . . . . . . . . . . . . . . . . 25 mg. Copper (Cupric Oxide) . . . . . . . . . . . . . . . . . 2 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. *Input as Vitamin A palmitate and beta carotene.</Description>
</NDC>
<NDC>
<NDCCode>63044-198-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (63044-198-01)</PackageDescription>
<NDC11Code>63044-0198-01</NDC11Code>
<ProductNDC>63044-198</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iferex 150 Forte</ProprietaryName>
<NonProprietaryName>Iron, Cyanocobalamin And Folic Acid</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071028</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>IRON; CYANOCOBALAMIN; FOLIC ACID</SubstanceName>
<StrengthNumber>150; 25; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-26</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63044-401-01</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (63044-401-01)</PackageDescription>
<NDC11Code>63044-0401-01</NDC11Code>
<ProductNDC>63044-401</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitamin D3dietary Supplemen</ProprietaryName>
<ProprietaryNameSuffix>Dietary Supplement</ProprietaryNameSuffix>
<NonProprietaryName>Cholecalciferol</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120114</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL</SubstanceName>
<StrengthNumber>.25; 5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63044-404-20</NDCCode>
<PackageDescription>140 g in 1 TUBE (63044-404-20)</PackageDescription>
<NDC11Code>63044-0404-20</NDC11Code>
<ProductNDC>63044-404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ammonium Lactate</ProprietaryName>
<NonProprietaryName>Ammonium Lactate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20071230</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>AMMONIUM LACTATE</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ammonium Lactate Cream is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.</IndicationAndUsage>
<Description>Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Ingredients: Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light mineral oil, magnesium aluminum silicate, methyl and propyl parabens, Carbomer 940, PEG-100 stearate, polysorbate 85, triethanolamine, propylene glycol, Petrolatum and Sodium PCA, stearic acid and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>63044-484-09</NDCCode>
<PackageDescription>225 g in 1 BOTTLE, PLASTIC (63044-484-09)</PackageDescription>
<NDC11Code>63044-0484-09</NDC11Code>
<ProductNDC>63044-484</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ammonium Lactate</ProprietaryName>
<NonProprietaryName>Ammonium Lactate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20071230</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>AMMONIUM LACTATE</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ammonium Lactate Lotion is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.</IndicationAndUsage>
<Description>Ammonium Lactate Lotion, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Ingredients: Ammonium Lactate Lotion, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light mineral oil, magnesium aluminum silicate, methyl and propyl parabens, Carbomer 940, PEG-100 stearate, polysorbate 85, triethanolamine, propylene glycol, Petrolatum and Sodium PCA, stearic acid and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>63044-622-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (63044-622-01) </PackageDescription>
<NDC11Code>63044-0622-01</NDC11Code>
<ProductNDC>63044-622</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reno Caps</ProprietaryName>
<NonProprietaryName>Reno Caps</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081130</StartMarketingDate>
<EndMarketingDate>20181130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>ASCORBIC ACID; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; BIOTIN; PANTOTHENIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>100; 1.5; 1.7; 20; 10; 1; 150; 5; 6</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20081130</StartMarketingDatePackage>
<EndMarketingDatePackage>20181130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63044-622-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (63044-622-30) </PackageDescription>
<NDC11Code>63044-0622-30</NDC11Code>
<ProductNDC>63044-622</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reno Caps</ProprietaryName>
<NonProprietaryName>Reno Caps</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081130</StartMarketingDate>
<EndMarketingDate>20181130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>ASCORBIC ACID; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; BIOTIN; PANTOTHENIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>100; 1.5; 1.7; 20; 10; 1; 150; 5; 6</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20081130</StartMarketingDatePackage>
<EndMarketingDatePackage>20181130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63044-622-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (63044-622-90) </PackageDescription>
<NDC11Code>63044-0622-90</NDC11Code>
<ProductNDC>63044-622</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reno Caps</ProprietaryName>
<NonProprietaryName>Reno Caps</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081130</StartMarketingDate>
<EndMarketingDate>20181130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>ASCORBIC ACID; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; BIOTIN; PANTOTHENIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>100; 1.5; 1.7; 20; 10; 1; 150; 5; 6</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20081130</StartMarketingDatePackage>
<EndMarketingDatePackage>20181130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63044-631-19</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX (63044-631-19) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63044-0631-19</NDC11Code>
<ProductNDC>63044-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hematogen</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Ascorbic Acid, Intrinsic Factor , Cyanocobalamin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070510</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; INTRINSIC FACTOR</SubstanceName>
<StrengthNumber>250; 10; 66; 100</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63044-632-17</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX (63044-632-17) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63044-0632-17</NDC11Code>
<ProductNDC>63044-632</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hematogen Fa</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Ascorbic Acid, Folic Acid, Cyanocobalamin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID</SubstanceName>
<StrengthNumber>250; 10; 66; 1</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>CONTENTS : Each maroon and brown soft gelatin capsule contains. Ferrous fumarate ........................................................................200 mg. (66 mg elemental iron). Ascorbic acid ..............................................................................250 mg. Folic acid ........................................................................................1 mg. Cyanocobalamin .........................................................................10 mcg. DISCUSSION : The amount of elemental iron and the absorption of the iron components of commercial iron preparations vary widely. It is further established that certain "accessory components" may be included to enhance absorption and utilization of iron. Hematogen FA Capsules are formulated to provide the essential factors for a complete, versatile hematinic.</Description>
</NDC>
<NDC>
<NDCCode>63044-633-21</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX (63044-633-21) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63044-0633-21</NDC11Code>
<ProductNDC>63044-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hematogen Forte</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Ascorbic Acid, Folic Acid, Cyanocobalamin</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070510</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID</SubstanceName>
<StrengthNumber>1; 10; 151; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence.</IndicationAndUsage>
<Description>Each brown soft gelatin capsule contains. Ferrous fumarate............................................................................ 460 mg. (151 mg elemental iron). Ascorbic acid.................................................................................... 60 mg. Folic acid............................................................................................ 1 mg. Cyanocobalamin.............................................................................10 mcg. The amount of elemental iron and the absorption of the iron components of commercial iron preparations vary widely. It is further established that certain "accessory components" may be included to enhance absorption and utilization of iron. Hematogen Forte Capsules are formulated to provide the essential factors for a complete, versatile hematinic. Inactive Ingredients: Soybean oil, Lecithin, Glycerin, hydrogenated soybean oil, Yellow Beewax, Titanium Oxide.</Description>
</NDC>
<NDC>
<NDCCode>63044-635-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX (63044-635-10) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63044-0635-10</NDC11Code>
<ProductNDC>63044-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tricon</ProprietaryName>
<NonProprietaryName>Tricon</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050520</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>CYANOCOBALAMIN; FERROUS FUMARATE; ASCORBIC ACID; FOLIC ACID</SubstanceName>
<StrengthNumber>15; 110; 75; .5</StrengthNumber>
<StrengthUnit>ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRICON is a multifactor preparation effective in the treatment of anemias that respond to oral hematinics, including pernicious anemia and other megaloblastic anemias and also irondeficiency anemia. Therapeutic quantities of hematopoietic factors that are known to be important are present in the recommended daily dose.</IndicationAndUsage>
<Description>Each TRICON Capsule contains. Special liver-stomach concentrate. (containing intrinsic factor). . . . . . . . . . . . . . . . 240 mg. Vitamin B12 (activity equivalent) . . . . . . . . . . . .15 mcg. Iron, elemental (ferrous fumarate) . . . . . . . . . .110 mg. Vitamin C (ascorbic acid) . . . . . . . . . . . . . . . . . 75 mg. Folic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 mg. with other factors of vitamin B complex present in the liver-stomach concentrate. Inactive ingredients: Citric acid, D&C Yellow No. 10, ethylcellulose, FD&C Blue No. 1, FD&C Red #28, gelatin, lecithin, magnesium stearate, pharmaceutical glaze, silicon dioxide, simethicone, sodium benzoate, sodium citrate, sorbic acid, starch, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0065-0343-02</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00065-0343-02</NDC11Code>
<ProductNDC>0065-0343</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20150115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207926</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
</NDC>
<NDC>
<NDCCode>0065-0349-04</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0349-04) / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00065-0349-04</NDC11Code>
<ProductNDC>0065-0349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20150115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207926</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
</NDC>
<NDC>
<NDCCode>0065-0349-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0349-05) / 2 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00065-0349-05</NDC11Code>
<ProductNDC>0065-0349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20150115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207926</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
</NDC>
<NDC>
<NDCCode>0065-0359-02</NDCCode>
<PackageDescription>2 mL in 1 BOTTLE, PLASTIC (0065-0359-02) </PackageDescription>
<NDC11Code>00065-0359-02</NDC11Code>
<ProductNDC>0065-0359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclomydril</ProprietaryName>
<NonProprietaryName>Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19580630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084300</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2; 10</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19580630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the production of mydriasis.</IndicationAndUsage>
<Description>CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution. The active ingredients are represented by the chemical structures. Established Name:Cyclopentolate Hydrochloride. Chemical Name:2-(Dimethylamino)ethyl 1 - hydroxy-α-phenylcyclopentaneacetate hydrochloride). Molecular Formula:C17H25NO3 HCl. Molecular Weight:327.85 g/mol. Established Name:Phenylephrine Hydrochloride. Chemical Name:3-hydroxy-α[(methylamino)-methyl]-, Benzenemethanol, hydrochloride (R)-. Molecular Formula:C9H13NO2 HCl. Molecular Weight:203.67 g/mol. Each mL of CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) contains:Active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. Preservative: benzalkonium chloride 0.01%.Inactives: edetate disodium, boric acid, hydrochloric acid and /or sodium carbonate (to adjust pH), purified water.</Description>
</NDC>
<NDC>
<NDCCode>0065-0359-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, PLASTIC (0065-0359-05) </PackageDescription>
<NDC11Code>00065-0359-05</NDC11Code>
<ProductNDC>0065-0359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclomydril</ProprietaryName>
<NonProprietaryName>Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19580630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084300</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2; 10</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19580630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the production of mydriasis.</IndicationAndUsage>
<Description>CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution. The active ingredients are represented by the chemical structures. Established Name:Cyclopentolate Hydrochloride. Chemical Name:2-(Dimethylamino)ethyl 1 - hydroxy-α-phenylcyclopentaneacetate hydrochloride). Molecular Formula:C17H25NO3 HCl. Molecular Weight:327.85 g/mol. Established Name:Phenylephrine Hydrochloride. Chemical Name:3-hydroxy-α[(methylamino)-methyl]-, Benzenemethanol, hydrochloride (R)-. Molecular Formula:C9H13NO2 HCl. Molecular Weight:203.67 g/mol. Each mL of CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) contains:Active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. Preservative: benzalkonium chloride 0.01%.Inactives: edetate disodium, boric acid, hydrochloric acid and /or sodium carbonate (to adjust pH), purified water.</Description>
</NDC>
<NDC>
<NDCCode>0121-0925-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0121-0925-16) </PackageDescription>
<NDC11Code>00121-0925-16</NDC11Code>
<ProductNDC>0121-0925</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Vc With Codeine Oral Solution</ProprietaryName>
<NonProprietaryName>Promethazine And Phenylephrine Hydrochloride And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210318</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040660</ApplicationNumber>
<LabelerName>PAI Holdings, LLC</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 5; 6.25</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine VC with Codeine Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]. Contraindicated in pediatric patients under 12 years of age [see Contraindications (4) and Use in Specific Populations (8.4)]. Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4) and Use in Specific Populations (8.4)]. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Promethazine VC with Codeine Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks,and in whom an adequate assessment of the etiology of the cough has been made.</IndicationAndUsage>
<Description>Promethazine VC with Codeine Oral Solution (promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate) oral solution contains codeine an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist. Each 5 mL of Promethazine VC with Codeine Oral Solution contains 10 mg of codeine phosphate, 6.25 mg of promethazine hydrochloride, and 5 mg of phenylephrine hydrochloride for oral administration. Promethazine VC with Codeine Oral Solution has a pH between 4.4 and 5.2 and contains alcohol 7%. Promethazine VC with Codeine Oral Solution also contains the following inactive ingredients: Ascorbic acid, citric acid, D&C Red #33, FD&C Yellow #6, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate, strawberry flavor and sucrose. Codeine Phosphate. The chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C 18H 21NO 3H 3PO 4 ½ H 2O, and it has the following chemical structure. Promethazine Hydrochloride. The chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C 17H 20N 2SHCl, and it has the following chemical structure. Phenylephrine Hydrochloride. The chemical name for phenylephrine hydrochloride, a sympathomimetic amine salt, is (-)- m-hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. The molecular weight is 203.67. Its molecular formula is C 9H 13NO 2 HCl, and it has the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>0121-0926-16</NDCCode>
<PackageDescription>437 mL in 1 BOTTLE (0121-0926-16) </PackageDescription>
<NDC11Code>00121-0926-16</NDC11Code>
<ProductNDC>0121-0926</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Vc</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210311</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040654</ApplicationNumber>
<LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 6.25</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210311</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg. Alcohol 7%. Inactive Ingredients: Apricot peach flavor, ascorbic acid, citric acid, FD&C yellow #6, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17H 20N 2SHCI, and the following structural formula:. Phenylephrine hydrochloride is a sympathomimetic amine salt which is chemically designated as (-)-m-Hydroxy-α-[(methylamino)methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. It has a molecular weight of 203.67, a molecular formula of C 9H 13NO 2HCI, and the following structural formula:.</Description>
</NDC>
</NDCList>