{
"NDC": [
{
"NDCCode": "63776-628-15",
"PackageDescription": "50 mL in 1 BOTTLE (63776-628-15) ",
"NDC11Code": "63776-0628-15",
"ProductNDC": "63776-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bdnf",
"NonProprietaryName": "Brain-derived Neurotrophic Factor Human",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN",
"StrengthNumber": "30",
"StrengthUnit": "[kp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20171101",
"SamplePackage": "N"
},
{
"NDCCode": "63776-628-11",
"PackageDescription": ".5 mL in 1 AMPULE (63776-628-11) ",
"NDC11Code": "63776-0628-11",
"ProductNDC": "63776-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bdnf",
"NonProprietaryName": "Brain-derived Neurotrophic Factor Human",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN",
"StrengthNumber": "30",
"StrengthUnit": "[kp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20171101",
"SamplePackage": "N"
},
{
"NDCCode": "63776-628-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-628-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0628-14",
"ProductNDC": "63776-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bdnf",
"NonProprietaryName": "Brain-derived Neurotrophic Factor Human",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN",
"StrengthNumber": "30",
"StrengthUnit": "[kp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "To help with symptoms of weakened mental function & neurological challenges."
},
{
"NDCCode": "63776-628-16",
"PackageDescription": "100 mL in 1 BOTTLE (63776-628-16) ",
"NDC11Code": "63776-0628-16",
"ProductNDC": "63776-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bdnf",
"NonProprietaryName": "Brain-derived Neurotrophic Factor Human",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN",
"StrengthNumber": "30",
"StrengthUnit": "[kp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20171101",
"SamplePackage": "N"
},
{
"NDCCode": "63776-628-17",
"PackageDescription": "250 mL in 1 BOTTLE (63776-628-17) ",
"NDC11Code": "63776-0628-17",
"ProductNDC": "63776-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bdnf",
"NonProprietaryName": "Brain-derived Neurotrophic Factor Human",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN",
"StrengthNumber": "30",
"StrengthUnit": "[kp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20171101",
"SamplePackage": "N"
},
{
"NDCCode": "16477-628-15",
"PackageDescription": "15 mL in 1 BOTTLE (16477-628-15)",
"NDC11Code": "16477-0628-15",
"ProductNDC": "16477-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neo",
"ProprietaryNameSuffix": "Ac",
"NonProprietaryName": "Codeine Phosphate, Pseudoephedrine Hydrochloride, Pyrilamine Maleate",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20090922",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Laser Pharmaceuticals LLC",
"SubstanceName": "CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "10; 30; 15",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "43744-628-15",
"PackageDescription": "10 g in 1 DRUM (43744-628-15)",
"NDC11Code": "43744-0628-15",
"ProductNDC": "43744-628",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Monobenzone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20121001",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "MONOBENZONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "43744-628-20",
"PackageDescription": "15 g in 1 DRUM (43744-628-20)",
"NDC11Code": "43744-0628-20",
"ProductNDC": "43744-628",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Monobenzone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20121001",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "MONOBENZONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "50268-628-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-628-15) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-628-11) ",
"NDC11Code": "50268-0628-15",
"ProductNDC": "50268-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078503",
"LabelerName": "AvPAK",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120525",
"SamplePackage": "N",
"IndicationAndUsage": "Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).",
"Description": "Oxybutynin chloride extended-release tablets are an antispasmodic, muscarinic antagonist. Each Oxybutynin chloride extended-release tablets contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22H 31NO 3HCl. Its structural formula is. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride extended-release tablets also contain the following inert ingredients: lactose, mannitol, dextrose, tartaric acid, colloidal silicon dioxide, magnesium stearate, cellulose acetate, polyethylene glycol, titanium dioxide, triacetin, black iron oxide, propylene glycol, hypromellose."
},
{
"NDCCode": "60687-628-07",
"PackageDescription": "8 TRAY in 1 CASE (60687-628-07) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) ",
"NDC11Code": "60687-0628-07",
"ProductNDC": "60687-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220228",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211648",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220901",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
},
{
"NDCCode": "60687-628-16",
"PackageDescription": "10 TRAY in 1 CASE (60687-628-16) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) ",
"NDC11Code": "60687-0628-16",
"ProductNDC": "60687-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220228",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211648",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240526",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
},
{
"NDCCode": "60687-628-58",
"PackageDescription": "3 TRAY in 1 CASE (60687-628-58) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) ",
"NDC11Code": "60687-0628-58",
"ProductNDC": "60687-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220228",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211648",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220706",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
},
{
"NDCCode": "60687-628-64",
"PackageDescription": "4 TRAY in 1 CASE (60687-628-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) ",
"NDC11Code": "60687-0628-64",
"ProductNDC": "60687-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220228",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211648",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220311",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
},
{
"NDCCode": "60687-628-71",
"PackageDescription": "5 TRAY in 1 CASE (60687-628-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) ",
"NDC11Code": "60687-0628-71",
"ProductNDC": "60687-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220228",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211648",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220801",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
},
{
"NDCCode": "69517-628-17",
"PackageDescription": "1 BOTTLE in 1 CARTON (69517-628-17) > 15 mL in 1 BOTTLE",
"NDC11Code": "69517-0628-17",
"ProductNDC": "69517-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180109",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Healthlife of USA",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180109",
"SamplePackage": "N"
},
{
"NDCCode": "70645-628-35",
"PackageDescription": "15 PATCH in 1 BOX (70645-628-35) ",
"NDC11Code": "70645-0628-35",
"ProductNDC": "70645-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gen7t Plus",
"NonProprietaryName": "Lidocaine, Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190901",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "7T Pharma LLC",
"SubstanceName": "LIDOCAINE; MENTHOL",
"StrengthNumber": "490; 980",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"Description": "Gen7T Plus Patch® is a prescription topical patch containing 15 articulated patches or 10 articulated patches. Lidocaine is present in a 3.5% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C14H22N2O. The molecular weight of lidocaine is 234.34 g/mol. Lidocaine has an octanol: water partition ration of 43 at pH 7.4, and has the following structure:. ** Lidocaine **. Menthol is present in a 7% concentration (w/w). The chemical name is (1R,2S,5R)‐2‐isopropyl-5-methylcyclohexanol. The empirical formula for Menthol is C10H20O with a molecular weight of 156.27 g/mol. Menthol contains colorless, hexangonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. It has a melting point between 31OC to 36OC and has the following structure:. ** Menthol **. Gen7T Plus Patch® uses an adhesive hydrogel technology containing lidocaine 3.5% and menthol 7%, applied to a flexible woven polyester backing and protected by a plastic film. The protective film is removed prior to application to the skin."
},
{
"NDCCode": "71919-628-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-628-07) ",
"NDC11Code": "71919-0628-07",
"ProductNDC": "71919-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Silica Marina",
"NonProprietaryName": "Silicon Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SILICON DIOXIDE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110517",
"SamplePackage": "N"
},
{
"NDCCode": "63776-027-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-027-15) > 50 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0027-15",
"ProductNDC": "63776-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aller Balance",
"NonProprietaryName": "Choline Chloride, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Epinephrine, Onion, Ammonium Carbonate, Apis Mellifera, Arsenic Trioxide, Histamine, Interferon Gamma-1a, Interleukin-12 Human, Manganese Gluconate, Luffa Operculata Fruit, Sus Scrofa Lung, Beef Lung, Sus Scrofa Nasal Mucosa, Bos Taurus Nasal Mucosa, Sodium Chloride, Bos Taurus Peyers Patch, Sus Scrofa Peyers Patch, Schoenocaulon Officinale Seed, Serotonin, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; BEEF LUNG; BOS TAURUS ADRENAL GLAND; BOS TAURUS NASAL MUCOSA; BOS TAURUS PEYER'S PATCH; BOS TAURUS THYMUS; CHOLINE CHLORIDE; EPINEPHRINE; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; LUFFA OPERCULATA FRUIT; MANGANESE GLUCONATE; ONION; SCHOENOCAULON OFFICINALE SEED; SEROTONIN; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SUS SCROFA PEYER'S PATCH; SUS SCROFA THYMUS",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 30; 4; 200; 200; 200; 200; 200; 200; 200; 30; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Magnetic Resonance Contrast Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Paramagnetic Contrast Agent [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "To assist with balancing the terrain associated with sensitivities."
},
{
"NDCCode": "63776-033-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-033-15) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0033-15",
"ProductNDC": "63776-033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ans/cns",
"NonProprietaryName": "Choline Chloride, Epinephrine, .gamma.-aminobutyric Acid, Histamine, Goldenseal, Norepinephrine, Taraxacum Palustre Root, Tyramine",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": ".GAMMA.-AMINOBUTYRIC ACID; CHOLINE CHLORIDE; EPINEPHRINE; GOLDENSEAL; HISTAMINE; NOREPINEPHRINE; TARAXACUM PALUSTRE ROOT; TYRAMINE",
"StrengthNumber": "200; 200; 200; 3; 200; 200; 30; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamine [EPC], Catecholamines [CS], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "For the support & balancing of the Anatomic & Central nervous systems."
},
{
"NDCCode": "63776-035-15",
"PackageDescription": "50 mL in 1 BOTTLE (63776-035-15) ",
"NDC11Code": "63776-0035-15",
"ProductNDC": "63776-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthros",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": ".ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; ASCORBIC ACID; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS CARTILAGE; BOS TAURUS JOINT CAPSULE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PLACENTA; BOS TAURUS RED BLOOD CELL; BOS TAURUS SOLAR PLEXUS; BOS TAURUS VEIN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CALCITONIN; COLCHICUM AUTUMNALE BULB; EDODEKIN ALFA; ERSOFERMIN; INTERFERON GAMMA-1A; METENKEFALIN; NADIDE; PORK COLLAGEN; PORK LIVER; QUINHYDRONE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA CARTILAGE; SUS SCROFA JOINT CAPSULE; SUS SCROFA LYMPH; SUS SCROFA MESENCHYME; SUS SCROFA PARATHYROID GLAND; SUS SCROFA RED BLOOD CELL; SUS SCROFA SOLAR PLEXUS; SUS SCROFA VEIN",
"StrengthNumber": "30; 30; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dopamine Agonists [MoA], Dopaminergic Agonist [EPC], Increased Histamine Release [PE], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N"
},
{
"NDCCode": "63776-037-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-037-15) > 50 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0037-15",
"ProductNDC": "63776-037",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Articula",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Bos Taurus Ankle Joint, Sus Scrofa Ankle Joint, Metenkefalin, Ersofermin, Bos Taurus Achilles Tendon, Sus Scrofa Achilles Tendon, Bos Taurus Hip Joint, Sus Scrofa Hip Joint, Bos Taurus Knee Joint, Sus Scrofa Knee Joint, Beef Liver, Pork Liver, Transforming Growth Factor Beta-1, Avotermin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; AVOTERMIN; BEEF LIVER; BOS TAURUS ACHILLES TENDON; BOS TAURUS ANKLE JOINT; BOS TAURUS HIP JOINT; BOS TAURUS KNEE JOINT; ERSOFERMIN; METENKEFALIN; PORK LIVER; SUS SCROFA ACHILLES TENDON; SUS SCROFA ANKLE JOINT; SUS SCROFA HIP JOINT; SUS SCROFA KNEE JOINT; TRANSFORMING GROWTH FACTOR BETA-1",
"StrengthNumber": "200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191105",
"SamplePackage": "N"
},
{
"NDCCode": "63776-039-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-039-15) > 50 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0039-15",
"ProductNDC": "63776-039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ans/cns",
"NonProprietaryName": "Choline Chloride, Epinephrine, .gamma.-aminobutyric Acid, Histamine, Goldenseal, Norepinephrine, Taraxacum Palustre Root, Tyramine",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": ".GAMMA.-AMINOBUTYRIC ACID; CHOLINE CHLORIDE; EPINEPHRINE; GOLDENSEAL; HISTAMINE; NOREPINEPHRINE; TARAXACUM PALUSTRE ROOT; TYRAMINE",
"StrengthNumber": "200; 200; 200; 3; 200; 200; 30; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamine [EPC], Catecholamines [CS], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "For the support & balancing of the Anatomic & Central nervous systems."
},
{
"NDCCode": "63776-073-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-073-15) > 50 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0073-15",
"ProductNDC": "63776-073",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida",
"NonProprietaryName": "Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Vaccinium Vitis-idaea Leaf",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200; 200; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms due to Candida, including precursors and byproducts."
},
{
"NDCCode": "63776-074-15",
"PackageDescription": "50 mL in 1 BOTTLE (63776-074-15) ",
"NDC11Code": "63776-0074-15",
"ProductNDC": "63776-074",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida Plus",
"NonProprietaryName": "Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Vaccinium Vitis-idaea Leaf",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200; 200; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms due to Candida, including precursors and byproducts."
},
{
"NDCCode": "63776-075-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-075-15) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0075-15",
"ProductNDC": "63776-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida I",
"NonProprietaryName": "Caffeic Acid, Candida Albicans, Tanacetum Parthenium, Centella Asiatica, Yeast Mannan, Penicillin G, Vaccinium Vitis-idaea Leaf Spray",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "CAFFEIC ACID; CANDIDA ALBICANS; CENTELLA ASIATICA; TANACETUM PARTHENIUM; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN",
"StrengthNumber": "200; 200; 200; 200; 200; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms due to Candida, specific for drainage."
},
{
"NDCCode": "63776-078-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-078-15) > 50 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0078-15",
"ProductNDC": "63776-078",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida I",
"NonProprietaryName": "Caffeic Acid, Candida Albicans, Tanacetum Parthenium, Centella Asiatica, Yeast Mannan, Vaccinium Vitis-idaea Leaf Spray",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "CAFFEIC ACID; CANDIDA ALBICANS; CENTELLA ASIATICA; TANACETUM PARTHENIUM; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN",
"StrengthNumber": "200; 200; 200; 200; 200; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms due to Candida, specific for drainage."
},
{
"NDCCode": "63776-081-15",
"PackageDescription": "50 mL in 1 BOTTLE (63776-081-15) ",
"NDC11Code": "63776-0081-15",
"ProductNDC": "63776-081",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-cellulite",
"NonProprietaryName": "Androsterone, Artichoke, Atp, Bfgf, Camp, L-carnitine, Centella Asiatica, Citric Acid, Cobalt, Estrogen, Ferrum Fumaricum, Fumaric Acid, Ginkgo, Hamamelis, Hyaluronidase, Il-3, Kalium Asparticum, Lactic Acid, Lymphatic Vessel, Melilotus, Mn, Natrum Oxalaceticum, Natrum Pyruvicum, Quinhydrone, Succinic Acid, Vein, Vitamin A And Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; ADENOSINE TRIPHOSPHATE; ANDROSTERONE; ARTICHOKE; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BOS TAURUS LYMPH VESSEL; BOS TAURUS VEIN; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COBALT; ERSOFERMIN; ESTROGENS, ESTERIFIED; FERROUS FUMARATE; FUMARIC ACID; HAMAMELIS VIRGINIANA BARK; HEPTAMINOL; HYALURONIDASE; INTERLEUKIN-3; LACTIC ACID; LEVOCARNITINE; MANGANESE; MELILOTUS OFFICINALIS WHOLE; POTASSIUM ASPARTATE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA LYMPH VESSEL; SUS SCROFA VEIN; VITAMIN A; ZINC",
"StrengthNumber": "30; 30; 30; 30; 200; 200; 200; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Acidifying Activity [MoA], Allergens [CS], Allergens [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Carnitine Analog [EPC], Carnitine [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS], Vitamin A [CS], Vitamin A [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N",
"IndicationAndUsage": "Cellulite drainage & tonification, metabolism and lipid balance, hormonal support, circulatory support and regeneration."
},
{
"NDCCode": "63776-095-15",
"PackageDescription": "50 mL in 1 BOTTLE (63776-095-15) ",
"NDC11Code": "63776-0095-15",
"ProductNDC": "63776-095",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Collagen",
"NonProprietaryName": "Pork Collagen",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
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},
{
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},
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"NDCCode": "63776-142-15",
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}
]
}
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<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
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<StrengthUnit>g/g</StrengthUnit>
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<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
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<NDCCode>50268-628-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-628-15) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-628-11) </PackageDescription>
<NDC11Code>50268-0628-15</NDC11Code>
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<LabelerName>AvPAK</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).</IndicationAndUsage>
<Description>Oxybutynin chloride extended-release tablets are an antispasmodic, muscarinic antagonist. Each Oxybutynin chloride extended-release tablets contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22H 31NO 3HCl. Its structural formula is. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride extended-release tablets also contain the following inert ingredients: lactose, mannitol, dextrose, tartaric acid, colloidal silicon dioxide, magnesium stearate, cellulose acetate, polyethylene glycol, titanium dioxide, triacetin, black iron oxide, propylene glycol, hypromellose.</Description>
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<NDCCode>60687-628-07</NDCCode>
<PackageDescription>8 TRAY in 1 CASE (60687-628-07) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) </PackageDescription>
<NDC11Code>60687-0628-07</NDC11Code>
<ProductNDC>60687-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220228</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211648</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220901</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
</NDC>
<NDC>
<NDCCode>60687-628-16</NDCCode>
<PackageDescription>10 TRAY in 1 CASE (60687-628-16) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) </PackageDescription>
<NDC11Code>60687-0628-16</NDC11Code>
<ProductNDC>60687-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220228</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211648</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240526</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
</NDC>
<NDC>
<NDCCode>60687-628-58</NDCCode>
<PackageDescription>3 TRAY in 1 CASE (60687-628-58) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) </PackageDescription>
<NDC11Code>60687-0628-58</NDC11Code>
<ProductNDC>60687-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220228</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211648</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220706</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
</NDC>
<NDC>
<NDCCode>60687-628-64</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (60687-628-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) </PackageDescription>
<NDC11Code>60687-0628-64</NDC11Code>
<ProductNDC>60687-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220228</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211648</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220311</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
</NDC>
<NDC>
<NDCCode>60687-628-71</NDCCode>
<PackageDescription>5 TRAY in 1 CASE (60687-628-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) </PackageDescription>
<NDC11Code>60687-0628-71</NDC11Code>
<ProductNDC>60687-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220228</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211648</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
</NDC>
<NDC>
<NDCCode>69517-628-17</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69517-628-17) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69517-0628-17</NDC11Code>
<ProductNDC>69517-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Healthlife of USA</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70645-628-35</NDCCode>
<PackageDescription>15 PATCH in 1 BOX (70645-628-35) </PackageDescription>
<NDC11Code>70645-0628-35</NDC11Code>
<ProductNDC>70645-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gen7t Plus</ProprietaryName>
<NonProprietaryName>Lidocaine, Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>7T Pharma LLC</LabelerName>
<SubstanceName>LIDOCAINE; MENTHOL</SubstanceName>
<StrengthNumber>490; 980</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Gen7T Plus Patch® is a prescription topical patch containing 15 articulated patches or 10 articulated patches. Lidocaine is present in a 3.5% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C14H22N2O. The molecular weight of lidocaine is 234.34 g/mol. Lidocaine has an octanol: water partition ration of 43 at pH 7.4, and has the following structure:. ** Lidocaine **. Menthol is present in a 7% concentration (w/w). The chemical name is (1R,2S,5R)‐2‐isopropyl-5-methylcyclohexanol. The empirical formula for Menthol is C10H20O with a molecular weight of 156.27 g/mol. Menthol contains colorless, hexangonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. It has a melting point between 31OC to 36OC and has the following structure:. ** Menthol **. Gen7T Plus Patch® uses an adhesive hydrogel technology containing lidocaine 3.5% and menthol 7%, applied to a flexible woven polyester backing and protected by a plastic film. The protective film is removed prior to application to the skin.</Description>
</NDC>
<NDC>
<NDCCode>71919-628-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-628-07) </PackageDescription>
<NDC11Code>71919-0628-07</NDC11Code>
<ProductNDC>71919-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Silica Marina</ProprietaryName>
<NonProprietaryName>Silicon Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SILICON DIOXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63776-027-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-027-15) > 50 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0027-15</NDC11Code>
<ProductNDC>63776-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aller Balance</ProprietaryName>
<NonProprietaryName>Choline Chloride, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Epinephrine, Onion, Ammonium Carbonate, Apis Mellifera, Arsenic Trioxide, Histamine, Interferon Gamma-1a, Interleukin-12 Human, Manganese Gluconate, Luffa Operculata Fruit, Sus Scrofa Lung, Beef Lung, Sus Scrofa Nasal Mucosa, Bos Taurus Nasal Mucosa, Sodium Chloride, Bos Taurus Peyers Patch, Sus Scrofa Peyers Patch, Schoenocaulon Officinale Seed, Serotonin, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; BEEF LUNG; BOS TAURUS ADRENAL GLAND; BOS TAURUS NASAL MUCOSA; BOS TAURUS PEYER'S PATCH; BOS TAURUS THYMUS; CHOLINE CHLORIDE; EPINEPHRINE; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; LUFFA OPERCULATA FRUIT; MANGANESE GLUCONATE; ONION; SCHOENOCAULON OFFICINALE SEED; SEROTONIN; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SUS SCROFA PEYER'S PATCH; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 30; 4; 200; 200; 200; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Magnetic Resonance Contrast Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Paramagnetic Contrast Agent [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To assist with balancing the terrain associated with sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-033-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-033-15) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0033-15</NDC11Code>
<ProductNDC>63776-033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ans/cns</ProprietaryName>
<NonProprietaryName>Choline Chloride, Epinephrine, .gamma.-aminobutyric Acid, Histamine, Goldenseal, Norepinephrine, Taraxacum Palustre Root, Tyramine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>.GAMMA.-AMINOBUTYRIC ACID; CHOLINE CHLORIDE; EPINEPHRINE; GOLDENSEAL; HISTAMINE; NOREPINEPHRINE; TARAXACUM PALUSTRE ROOT; TYRAMINE</SubstanceName>
<StrengthNumber>200; 200; 200; 3; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamine [EPC], Catecholamines [CS], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the support & balancing of the Anatomic & Central nervous systems.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-035-15</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (63776-035-15) </PackageDescription>
<NDC11Code>63776-0035-15</NDC11Code>
<ProductNDC>63776-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>.ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; ASCORBIC ACID; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS CARTILAGE; BOS TAURUS JOINT CAPSULE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PLACENTA; BOS TAURUS RED BLOOD CELL; BOS TAURUS SOLAR PLEXUS; BOS TAURUS VEIN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CALCITONIN; COLCHICUM AUTUMNALE BULB; EDODEKIN ALFA; ERSOFERMIN; INTERFERON GAMMA-1A; METENKEFALIN; NADIDE; PORK COLLAGEN; PORK LIVER; QUINHYDRONE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA CARTILAGE; SUS SCROFA JOINT CAPSULE; SUS SCROFA LYMPH; SUS SCROFA MESENCHYME; SUS SCROFA PARATHYROID GLAND; SUS SCROFA RED BLOOD CELL; SUS SCROFA SOLAR PLEXUS; SUS SCROFA VEIN</SubstanceName>
<StrengthNumber>30; 30; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dopamine Agonists [MoA], Dopaminergic Agonist [EPC], Increased Histamine Release [PE], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63776-037-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-037-15) > 50 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0037-15</NDC11Code>
<ProductNDC>63776-037</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Articula</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Bos Taurus Ankle Joint, Sus Scrofa Ankle Joint, Metenkefalin, Ersofermin, Bos Taurus Achilles Tendon, Sus Scrofa Achilles Tendon, Bos Taurus Hip Joint, Sus Scrofa Hip Joint, Bos Taurus Knee Joint, Sus Scrofa Knee Joint, Beef Liver, Pork Liver, Transforming Growth Factor Beta-1, Avotermin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; AVOTERMIN; BEEF LIVER; BOS TAURUS ACHILLES TENDON; BOS TAURUS ANKLE JOINT; BOS TAURUS HIP JOINT; BOS TAURUS KNEE JOINT; ERSOFERMIN; METENKEFALIN; PORK LIVER; SUS SCROFA ACHILLES TENDON; SUS SCROFA ANKLE JOINT; SUS SCROFA HIP JOINT; SUS SCROFA KNEE JOINT; TRANSFORMING GROWTH FACTOR BETA-1</SubstanceName>
<StrengthNumber>200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63776-039-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-039-15) > 50 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0039-15</NDC11Code>
<ProductNDC>63776-039</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ans/cns</ProprietaryName>
<NonProprietaryName>Choline Chloride, Epinephrine, .gamma.-aminobutyric Acid, Histamine, Goldenseal, Norepinephrine, Taraxacum Palustre Root, Tyramine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>.GAMMA.-AMINOBUTYRIC ACID; CHOLINE CHLORIDE; EPINEPHRINE; GOLDENSEAL; HISTAMINE; NOREPINEPHRINE; TARAXACUM PALUSTRE ROOT; TYRAMINE</SubstanceName>
<StrengthNumber>200; 200; 200; 3; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamine [EPC], Catecholamines [CS], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the support & balancing of the Anatomic & Central nervous systems.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-073-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-073-15) > 50 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0073-15</NDC11Code>
<ProductNDC>63776-073</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida</ProprietaryName>
<NonProprietaryName>Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Vaccinium Vitis-idaea Leaf</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms due to Candida, including precursors and byproducts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-074-15</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (63776-074-15) </PackageDescription>
<NDC11Code>63776-0074-15</NDC11Code>
<ProductNDC>63776-074</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida Plus</ProprietaryName>
<NonProprietaryName>Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Vaccinium Vitis-idaea Leaf</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms due to Candida, including precursors and byproducts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-075-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-075-15) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0075-15</NDC11Code>
<ProductNDC>63776-075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida I</ProprietaryName>
<NonProprietaryName>Caffeic Acid, Candida Albicans, Tanacetum Parthenium, Centella Asiatica, Yeast Mannan, Penicillin G, Vaccinium Vitis-idaea Leaf Spray</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>CAFFEIC ACID; CANDIDA ALBICANS; CENTELLA ASIATICA; TANACETUM PARTHENIUM; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms due to Candida, specific for drainage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-078-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-078-15) > 50 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0078-15</NDC11Code>
<ProductNDC>63776-078</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida I</ProprietaryName>
<NonProprietaryName>Caffeic Acid, Candida Albicans, Tanacetum Parthenium, Centella Asiatica, Yeast Mannan, Vaccinium Vitis-idaea Leaf Spray</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>CAFFEIC ACID; CANDIDA ALBICANS; CENTELLA ASIATICA; TANACETUM PARTHENIUM; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms due to Candida, specific for drainage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-081-15</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (63776-081-15) </PackageDescription>
<NDC11Code>63776-0081-15</NDC11Code>
<ProductNDC>63776-081</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-cellulite</ProprietaryName>
<NonProprietaryName>Androsterone, Artichoke, Atp, Bfgf, Camp, L-carnitine, Centella Asiatica, Citric Acid, Cobalt, Estrogen, Ferrum Fumaricum, Fumaric Acid, Ginkgo, Hamamelis, Hyaluronidase, Il-3, Kalium Asparticum, Lactic Acid, Lymphatic Vessel, Melilotus, Mn, Natrum Oxalaceticum, Natrum Pyruvicum, Quinhydrone, Succinic Acid, Vein, Vitamin A And Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; ADENOSINE TRIPHOSPHATE; ANDROSTERONE; ARTICHOKE; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BOS TAURUS LYMPH VESSEL; BOS TAURUS VEIN; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COBALT; ERSOFERMIN; ESTROGENS, ESTERIFIED; FERROUS FUMARATE; FUMARIC ACID; HAMAMELIS VIRGINIANA BARK; HEPTAMINOL; HYALURONIDASE; INTERLEUKIN-3; LACTIC ACID; LEVOCARNITINE; MANGANESE; MELILOTUS OFFICINALIS WHOLE; POTASSIUM ASPARTATE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA LYMPH VESSEL; SUS SCROFA VEIN; VITAMIN A; ZINC</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 200; 200; 200; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Allergens [CS], Allergens [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Carnitine Analog [EPC], Carnitine [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS], Vitamin A [CS], Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cellulite drainage & tonification, metabolism and lipid balance, hormonal support, circulatory support and regeneration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-095-15</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (63776-095-15) </PackageDescription>
<NDC11Code>63776-0095-15</NDC11Code>
<ProductNDC>63776-095</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Collagen</ProprietaryName>
<NonProprietaryName>Pork Collagen</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>PORK COLLAGEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[kp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63776-102-15</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (63776-102-15) </PackageDescription>
<NDC11Code>63776-0102-15</NDC11Code>
<ProductNDC>63776-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-mesenchyme</ProprietaryName>
<NonProprietaryName>Adrenal, Ascorbic Acid, Bdnf, Dhea, Malic Acid, Bfgf, Fucus Vesiculosus, Histidine, Hyaluronidase, Il-6, Lactic Acid, Lymph Node, Mesenchyme, Nad, Natrum Oxalaceticum, Natrum Pyruvicum, Natrum Sulphuricum, Phenylalanine, Amino Acid, Pyrogenium, Thuja Occidentalis, Trichinoyl, Tyrosine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; FUCUS VESICULOSUS; HISTIDINE; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); HYALURONIDASE; LACTIC ACID; MALIC ACID; NADIDE; PHENYLALANINE; PRASTERONE; PROLACTIN; RANCID BEEF; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA MESENCHYME; THUJA OCCIDENTALIS LEAF; TYROSINE</SubstanceName>
<StrengthNumber>30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30; 200; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help encourage extra cellular / matrix / connective tissue drainage & support.</IndicationAndUsage>
<Description>Viatrexx-Mesenchyme is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-142-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-142-15) > 50 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0142-15</NDC11Code>
<ProductNDC>63776-142</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-enzyme Plus</ProprietaryName>
<NonProprietaryName>Amylase, Cellulase, Lactase, Lipase, Maltase, Protease, Sucrase</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>CELLULASE (TRICHODERMA LONGIBRACHIATUM); LACTASE; LYSOSOMAL ALPHA-GLUCOSIDASE; PANCREATIC ALPHA-AMYLASE; PANCREATIC TRIACYLGLYCEROL LIPASE; PANCRELIPASE PROTEASE; SACROSIDASE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Sucrose-specific Enzyme [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To support healthy digestion.</IndicationAndUsage>
<Description>Viatrexx-Enzyme + is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
</NDCList>