{
"NDC": [
{
"NDCCode": "44946-1014-4",
"PackageDescription": "4 BOX in 1 BOX (44946-1014-4) > 24 BOTTLE in 1 BOX > 30 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "44946-1014-04",
"ProductNDC": "44946-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1014-5",
"PackageDescription": "4 BOX in 1 BOX (44946-1014-5) > 24 BOTTLE in 1 BOX > 90 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "44946-1014-05",
"ProductNDC": "44946-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1014-6",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BLISTER PACK (44946-1014-6)",
"NDC11Code": "44946-1014-06",
"ProductNDC": "44946-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1012-4",
"PackageDescription": "4 BOX in 1 BOX (44946-1012-4) > 24 BOTTLE in 1 BOX > 30 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "44946-1012-04",
"ProductNDC": "44946-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1012-5",
"PackageDescription": "4 BOX in 1 BOX (44946-1012-5) > 24 BOTTLE in 1 BOX > 90 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "44946-1012-05",
"ProductNDC": "44946-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1013-4",
"PackageDescription": "4 BOX in 1 BOX (44946-1013-4) > 24 BOTTLE in 1 BOX > 30 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "44946-1013-04",
"ProductNDC": "44946-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1013-5",
"PackageDescription": "4 BOX in 1 BOX (44946-1013-5) > 24 BOTTLE in 1 BOX > 90 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "44946-1013-05",
"ProductNDC": "44946-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1045-4",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (44946-1045-4) ",
"NDC11Code": "44946-1045-04",
"ProductNDC": "44946-1045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv Prenatal Plus Multivitamin",
"NonProprietaryName": "Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, And Cupric Oxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130401",
"EndMarketingDate": "20180410",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE",
"StrengthNumber": "2000; 2000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2",
"StrengthUnit": "[iU]/1; [iU]/1; mg/1; [iU]/1; mg/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 [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130401",
"EndMarketingDatePackage": "20180410",
"SamplePackage": "N"
},
{
"NDCCode": "44946-1046-4",
"PackageDescription": "400 TABLET in 1 BOTTLE, PLASTIC (44946-1046-4)",
"NDC11Code": "44946-1046-04",
"ProductNDC": "44946-1046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv Prenatal Vitamin",
"ProprietaryNameSuffix": "Plus Vitamin A",
"NonProprietaryName": ".alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous Fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, And Vitamin A Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121207",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; FERROUS FUMARATE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE",
"StrengthNumber": "15; 60; 400; 4.5; 1; 27; 50; 13.5; 1.05; 1.2; 1.05; 2500",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [CS],Vitamin A [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Each PNV tablet contains."
},
{
"NDCCode": "36987-1014-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1014-4)",
"NDC11Code": "36987-1014-04",
"ProductNDC": "36987-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dog Epithelium",
"NonProprietaryName": "Dog Epithelium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "CANIS LUPUS FAMILIARIS SKIN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "53852-1014-4",
"PackageDescription": "118 mL in 1 BOTTLE, SPRAY (53852-1014-4) ",
"NDC11Code": "53852-1014-04",
"ProductNDC": "53852-1014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "D-tox Remedy",
"NonProprietaryName": "Antimonium Tartaricum, Arsenicum Album, Bromium, Bryonia, Cadmium Metallicum, Carbo Vegetabilis, Carduus Marianus, Chininum Arsenicosum, Conium Maculatum, Echinacea Purpurea, Hepar Sulphuris Calcareum, Kali Bichromicum, Lacheses Mutus, Lobelia Inflata, Phosphorus, Phytolacca Decandra, Silicea, Solidago Virgaurea, Spongia Tosta, Sulphur Iodatum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181008",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Living Well Remedies, LLC",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; BROMINE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MILK THISTLE; ECHINACEA PURPUREA; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LOBELIA INFLATA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; SULFUR IODIDE; ARSENIC TRIOXIDE; CADMIUM; CONIUM MACULATUM FLOWERING TOP; QUININE ARSENATE; LACHESIS MUTA VENOM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181008",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Can assist the body with the process of detoxification after years of smoking. Helps to loosen and relieve congestion, mucus, and accumulated toxins from the nose, throat, larynx, lungs, kidneys, liver, blood, intestinal and lymphatic systems.*."
},
{
"NDCCode": "60396-1014-4",
"PackageDescription": "120 kg in 1 BAG (60396-1014-4) ",
"NDC11Code": "60396-1014-04",
"ProductNDC": "60396-1014",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20210907",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Antaria Pty Ltd",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "85",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "07-SEP-21"
},
{
"NDCCode": "64942-1014-4",
"PackageDescription": "1 CONTAINER in 1 CARTON (64942-1014-4) > 48 g in 1 CONTAINER (64942-1014-3)",
"NDC11Code": "64942-1014-04",
"ProductNDC": "64942-1014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Degree Clinical Protection Clean",
"ProprietaryNameSuffix": "Antiperspirant And Deodorant",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Conopco Inc. d/b/a Unilever",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "20",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "70710-1014-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1014-4) / 10 TABLET in 1 BLISTER PACK (70710-1014-2) ",
"NDC11Code": "70710-1014-04",
"ProductNDC": "70710-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210189",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190222",
"SamplePackage": "Y",
"IndicationAndUsage": "Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;, 2 hypoprothrombinemia secondary to antibacterial therapy;, 3 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis;, 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.",
"Description": "Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and slightly soluble in alcohol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is. Each uncoated phytonadione tablet, USP for oral administration contains 5 mg of phytonadione, USP and contains following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "71335-1014-4",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-1014-4) ",
"NDC11Code": "71335-1014-04",
"ProductNDC": "71335-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209025",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240809",
"SamplePackage": "N",
"IndicationAndUsage": "Oxybutynin Chloride is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).",
"Description": "Each scored oxybutynin chloride tablet contains 2.5 mg and 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C22H31NO3.HCl. The structural formula appears below. Oxybutynin chloride is a white crystalline practically odorless powder with a molecular weight of 393.9. It is freely soluble in water and in alcohol, very soluble in methanol and in chloroform, soluble in ether, very slightly soluble in hexane. Oxybutynin chloride Tablets, USP also contain Colloidal Silicon Dioxide, Microcrystalline Cellulose, Magnesium Stearate, Pregelatinized starch. Oxybutynin chloride Tablets, USP are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic. USP Dissolution Test 2 used."
},
{
"NDCCode": "71399-1014-4",
"PackageDescription": "400000 TABLET, COATED in 1 DRUM (71399-1014-4) ",
"NDC11Code": "71399-1014-04",
"ProductNDC": "71399-1014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Low Dose Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241206",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Akron Pharma Inc.",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241206",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relieve of headache or symptoms needing immediate relief."
},
{
"NDCCode": "76485-1014-1",
"PackageDescription": "4 g in 1 TUBE (76485-1014-1)",
"NDC11Code": "76485-1014-01",
"ProductNDC": "76485-1014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Moisture Renew",
"ProprietaryNameSuffix": "Summer Angel (640)",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111020",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Rimmel Inc.",
"SubstanceName": "OCTINOXATE; OCTISALATE",
"StrengthNumber": "300; 80",
"StrengthUnit": "mg/4g; mg/4g",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "83679-1014-4",
"PackageDescription": ".25 kg in 1 BOTTLE (83679-1014-4) ",
"NDC11Code": "83679-1014-04",
"ProductNDC": "83679-1014",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20210423",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Antaria Pty Ltd",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "50",
"StrengthUnit": "kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2026-06-11",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "23-APR-21"
},
{
"NDCCode": "85512-1014-4",
"PackageDescription": "50 g in 1 BOTTLE (85512-1014-4) ",
"NDC11Code": "85512-1014-04",
"ProductNDC": "85512-1014",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bremelanotide Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250602",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Qinzeyuan Biotechnology Co., Ltd",
"SubstanceName": "BREMELANOTIDE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "02-JUN-25"
},
{
"NDCCode": "44946-1012-6",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BLISTER PACK (44946-1012-6)",
"NDC11Code": "44946-1012-06",
"ProductNDC": "44946-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1012-7",
"PackageDescription": "7 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1012-7)",
"NDC11Code": "44946-1012-07",
"ProductNDC": "44946-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1013-6",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BLISTER PACK (44946-1013-6)",
"NDC11Code": "44946-1013-06",
"ProductNDC": "44946-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20091220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1020-5",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (44946-1020-5) ",
"NDC11Code": "44946-1020-05",
"ProductNDC": "44946-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc-fluoride",
"NonProprietaryName": "Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20111207",
"EndMarketingDate": "20180220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc.",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],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": "2018-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20111207",
"EndMarketingDatePackage": "20180220",
"SamplePackage": "N"
},
{
"NDCCode": "44946-1021-5",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (44946-1021-5) ",
"NDC11Code": "44946-1021-05",
"ProductNDC": "44946-1021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc-fluoride",
"NonProprietaryName": "Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20111207",
"EndMarketingDate": "20180220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc.",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": ".5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],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": "2018-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20111207",
"EndMarketingDatePackage": "20180220",
"SamplePackage": "N"
},
{
"NDCCode": "44946-1022-5",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (44946-1022-5)",
"NDC11Code": "44946-1022-05",
"ProductNDC": "44946-1022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvc-fluoride",
"NonProprietaryName": "Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20111207",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN",
"StrengthNumber": "1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5",
"StrengthUnit": "mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin A [Chemical/Ingredient],Vitamin A [EPC],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": "2018-02-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "44946-1023-1",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1023-1) ",
"NDC11Code": "44946-1023-01",
"ProductNDC": "44946-1023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multivitamin With Fluoride",
"NonProprietaryName": ".alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, And Vitamin D",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20111220",
"EndMarketingDate": "20180306",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D",
"StrengthNumber": "15; 60; 4.5; .25; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400",
"StrengthUnit": "[iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20111220",
"EndMarketingDatePackage": "20180306",
"SamplePackage": "N"
},
{
"NDCCode": "44946-1024-1",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1024-1) ",
"NDC11Code": "44946-1024-01",
"ProductNDC": "44946-1024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multivitamin With Fluoride",
"NonProprietaryName": ".alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, And Vitamin D",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20111220",
"EndMarketingDate": "20180306",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sancilio & Company Inc",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D",
"StrengthNumber": "15; 60; 4.5; .5; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400",
"StrengthUnit": "[iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20111220",
"EndMarketingDatePackage": "20180306",
"SamplePackage": "N"
},
{
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"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20111220",
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},
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"LabelerName": "Sancilio & Company Inc",
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"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Each PNV tablet contains."
},
{
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"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Each PNV tablet contains."
}
]
}
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<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StrengthNumber>.25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],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>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1013-4</NDCCode>
<PackageDescription>4 BOX in 1 BOX (44946-1013-4) > 24 BOTTLE in 1 BOX > 30 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>44946-1013-04</NDC11Code>
<ProductNDC>44946-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],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>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1013-5</NDCCode>
<PackageDescription>4 BOX in 1 BOX (44946-1013-5) > 24 BOTTLE in 1 BOX > 90 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>44946-1013-05</NDC11Code>
<ProductNDC>44946-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],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>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1045-4</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (44946-1045-4) </PackageDescription>
<NDC11Code>44946-1045-04</NDC11Code>
<ProductNDC>44946-1045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Prenatal Plus Multivitamin</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, And Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<EndMarketingDate>20180410</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE</SubstanceName>
<StrengthNumber>2000; 2000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2</StrengthNumber>
<StrengthUnit>[iU]/1; [iU]/1; mg/1; [iU]/1; mg/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 [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130401</StartMarketingDatePackage>
<EndMarketingDatePackage>20180410</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44946-1046-4</NDCCode>
<PackageDescription>400 TABLET in 1 BOTTLE, PLASTIC (44946-1046-4)</PackageDescription>
<NDC11Code>44946-1046-04</NDC11Code>
<ProductNDC>44946-1046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Prenatal Vitamin</ProprietaryName>
<ProprietaryNameSuffix>Plus Vitamin A</ProprietaryNameSuffix>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous Fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, And Vitamin A Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; FERROUS FUMARATE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE</SubstanceName>
<StrengthNumber>15; 60; 400; 4.5; 1; 27; 50; 13.5; 1.05; 1.2; 1.05; 2500</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [CS],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Each PNV tablet contains.</Description>
</NDC>
<NDC>
<NDCCode>36987-1014-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-1014-4)</PackageDescription>
<NDC11Code>36987-1014-04</NDC11Code>
<ProductNDC>36987-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dog Epithelium</ProprietaryName>
<NonProprietaryName>Dog Epithelium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>CANIS LUPUS FAMILIARIS SKIN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>53852-1014-4</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, SPRAY (53852-1014-4) </PackageDescription>
<NDC11Code>53852-1014-04</NDC11Code>
<ProductNDC>53852-1014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>D-tox Remedy</ProprietaryName>
<NonProprietaryName>Antimonium Tartaricum, Arsenicum Album, Bromium, Bryonia, Cadmium Metallicum, Carbo Vegetabilis, Carduus Marianus, Chininum Arsenicosum, Conium Maculatum, Echinacea Purpurea, Hepar Sulphuris Calcareum, Kali Bichromicum, Lacheses Mutus, Lobelia Inflata, Phosphorus, Phytolacca Decandra, Silicea, Solidago Virgaurea, Spongia Tosta, Sulphur Iodatum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181008</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Living Well Remedies, LLC</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; BROMINE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MILK THISTLE; ECHINACEA PURPUREA; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LOBELIA INFLATA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; SULFUR IODIDE; ARSENIC TRIOXIDE; CADMIUM; CONIUM MACULATUM FLOWERING TOP; QUININE ARSENATE; LACHESIS MUTA VENOM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Can assist the body with the process of detoxification after years of smoking. Helps to loosen and relieve congestion, mucus, and accumulated toxins from the nose, throat, larynx, lungs, kidneys, liver, blood, intestinal and lymphatic systems.*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60396-1014-4</NDCCode>
<PackageDescription>120 kg in 1 BAG (60396-1014-4) </PackageDescription>
<NDC11Code>60396-1014-04</NDC11Code>
<ProductNDC>60396-1014</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20210907</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Antaria Pty Ltd</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>85</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>07-SEP-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64942-1014-4</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (64942-1014-4) > 48 g in 1 CONTAINER (64942-1014-3)</PackageDescription>
<NDC11Code>64942-1014-04</NDC11Code>
<ProductNDC>64942-1014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Degree Clinical Protection Clean</ProprietaryName>
<ProprietaryNameSuffix>Antiperspirant And Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Conopco Inc. d/b/a Unilever</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70710-1014-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1014-4) / 10 TABLET in 1 BLISTER PACK (70710-1014-2) </PackageDescription>
<NDC11Code>70710-1014-04</NDC11Code>
<ProductNDC>70710-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210189</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190222</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;, 2 hypoprothrombinemia secondary to antibacterial therapy;, 3 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis;, 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.</IndicationAndUsage>
<Description>Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and slightly soluble in alcohol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is. Each uncoated phytonadione tablet, USP for oral administration contains 5 mg of phytonadione, USP and contains following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>71335-1014-4</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71335-1014-4) </PackageDescription>
<NDC11Code>71335-1014-04</NDC11Code>
<ProductNDC>71335-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209025</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxybutynin Chloride is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).</IndicationAndUsage>
<Description>Each scored oxybutynin chloride tablet contains 2.5 mg and 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C22H31NO3.HCl. The structural formula appears below. Oxybutynin chloride is a white crystalline practically odorless powder with a molecular weight of 393.9. It is freely soluble in water and in alcohol, very soluble in methanol and in chloroform, soluble in ether, very slightly soluble in hexane. Oxybutynin chloride Tablets, USP also contain Colloidal Silicon Dioxide, Microcrystalline Cellulose, Magnesium Stearate, Pregelatinized starch. Oxybutynin chloride Tablets, USP are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic. USP Dissolution Test 2 used.</Description>
</NDC>
<NDC>
<NDCCode>71399-1014-4</NDCCode>
<PackageDescription>400000 TABLET, COATED in 1 DRUM (71399-1014-4) </PackageDescription>
<NDC11Code>71399-1014-04</NDC11Code>
<ProductNDC>71399-1014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Low Dose Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Akron Pharma Inc.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relieve of headache or symptoms needing immediate relief.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76485-1014-1</NDCCode>
<PackageDescription>4 g in 1 TUBE (76485-1014-1)</PackageDescription>
<NDC11Code>76485-1014-01</NDC11Code>
<ProductNDC>76485-1014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Moisture Renew</ProprietaryName>
<ProprietaryNameSuffix>Summer Angel (640)</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111020</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Rimmel Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>300; 80</StrengthNumber>
<StrengthUnit>mg/4g; mg/4g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>83679-1014-4</NDCCode>
<PackageDescription>.25 kg in 1 BOTTLE (83679-1014-4) </PackageDescription>
<NDC11Code>83679-1014-04</NDC11Code>
<ProductNDC>83679-1014</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20210423</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Antaria Pty Ltd</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-06-11</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-APR-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>85512-1014-4</NDCCode>
<PackageDescription>50 g in 1 BOTTLE (85512-1014-4) </PackageDescription>
<NDC11Code>85512-1014-04</NDC11Code>
<ProductNDC>85512-1014</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bremelanotide Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Qinzeyuan Biotechnology Co., Ltd</LabelerName>
<SubstanceName>BREMELANOTIDE ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JUN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>44946-1012-6</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BLISTER PACK (44946-1012-6)</PackageDescription>
<NDC11Code>44946-1012-06</NDC11Code>
<ProductNDC>44946-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],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>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1012-7</NDCCode>
<PackageDescription>7 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1012-7)</PackageDescription>
<NDC11Code>44946-1012-07</NDC11Code>
<ProductNDC>44946-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],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>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1013-6</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BLISTER PACK (44946-1013-6)</PackageDescription>
<NDC11Code>44946-1013-06</NDC11Code>
<ProductNDC>44946-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],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>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1020-5</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (44946-1020-5) </PackageDescription>
<NDC11Code>44946-1020-05</NDC11Code>
<ProductNDC>44946-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc-fluoride</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111207</StartMarketingDate>
<EndMarketingDate>20180220</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],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>2018-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111207</StartMarketingDatePackage>
<EndMarketingDatePackage>20180220</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44946-1021-5</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (44946-1021-5) </PackageDescription>
<NDC11Code>44946-1021-05</NDC11Code>
<ProductNDC>44946-1021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc-fluoride</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111207</StartMarketingDate>
<EndMarketingDate>20180220</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],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>2018-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111207</StartMarketingDatePackage>
<EndMarketingDatePackage>20180220</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44946-1022-5</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (44946-1022-5)</PackageDescription>
<NDC11Code>44946-1022-05</NDC11Code>
<ProductNDC>44946-1022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvc-fluoride</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin A [Chemical/Ingredient],Vitamin A [EPC],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>2018-02-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44946-1023-1</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1023-1) </PackageDescription>
<NDC11Code>44946-1023-01</NDC11Code>
<ProductNDC>44946-1023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multivitamin With Fluoride</ProprietaryName>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, And Vitamin D</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111220</StartMarketingDate>
<EndMarketingDate>20180306</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D</SubstanceName>
<StrengthNumber>15; 60; 4.5; .25; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111220</StartMarketingDatePackage>
<EndMarketingDatePackage>20180306</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44946-1024-1</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1024-1) </PackageDescription>
<NDC11Code>44946-1024-01</NDC11Code>
<ProductNDC>44946-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multivitamin With Fluoride</ProprietaryName>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, And Vitamin D</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111220</StartMarketingDate>
<EndMarketingDate>20180306</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D</SubstanceName>
<StrengthNumber>15; 60; 4.5; .5; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111220</StartMarketingDatePackage>
<EndMarketingDatePackage>20180306</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44946-1025-1</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44946-1025-1) </PackageDescription>
<NDC11Code>44946-1025-01</NDC11Code>
<ProductNDC>44946-1025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multivitamin With Fluoride</ProprietaryName>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, And Vitamin D</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111220</StartMarketingDate>
<EndMarketingDate>20180306</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D</SubstanceName>
<StrengthNumber>15; 60; 4.5; 1; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111220</StartMarketingDatePackage>
<EndMarketingDatePackage>20180306</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44946-1046-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (44946-1046-0)</PackageDescription>
<NDC11Code>44946-1046-00</NDC11Code>
<ProductNDC>44946-1046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Prenatal Vitamin</ProprietaryName>
<ProprietaryNameSuffix>Plus Vitamin A</ProprietaryNameSuffix>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous Fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, And Vitamin A Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; FERROUS FUMARATE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE</SubstanceName>
<StrengthNumber>15; 60; 400; 4.5; 1; 27; 50; 13.5; 1.05; 1.2; 1.05; 2500</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [CS],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Each PNV tablet contains.</Description>
</NDC>
<NDC>
<NDCCode>44946-1046-2</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (44946-1046-2)</PackageDescription>
<NDC11Code>44946-1046-02</NDC11Code>
<ProductNDC>44946-1046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Prenatal Vitamin</ProprietaryName>
<ProprietaryNameSuffix>Plus Vitamin A</ProprietaryNameSuffix>
<NonProprietaryName>.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous Fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, And Vitamin A Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sancilio & Company Inc</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; FERROUS FUMARATE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE</SubstanceName>
<StrengthNumber>15; 60; 400; 4.5; 1; 27; 50; 13.5; 1.05; 1.2; 1.05; 2500</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [CS],Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Each PNV tablet contains.</Description>
</NDC>
</NDCList>