{
"NDC": [
{
"NDCCode": "62106-1136-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1136-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1136-08",
"ProductNDC": "62106-1136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 37",
"NonProprietaryName": "Petroselinum Sativum, Calendula Officinalis, Dulcamara, Lycopodium Clavatum, Hypericum Perforatum, Aurum Metallicum, Argentummetallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150116",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "SOLANUM DULCAMARA STEM; HYPERICUM PERFORATUM; GOLD; PETROSELINUM CRISPUM; CALENDULA OFFICINALIS FLOWERING TOP; SILVER; LYCOPODIUM CLAVATUM SPORE",
"StrengthNumber": "4; 4; 12; 4; 4; 12; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150116",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For the temporary relief of symptoms associated with minor inflammation. Directions Adults and adolescents (12 years and older) Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "70771-1136-8",
"PackageDescription": "16 CAPSULE, GELATIN COATED in 1 BOTTLE (70771-1136-8) ",
"NDC11Code": "70771-1136-08",
"ProductNDC": "70771-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065217",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171123",
"SamplePackage": "N"
},
{
"NDCCode": "0093-1136-56",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0093-1136-56) ",
"NDC11Code": "00093-1136-56",
"ProductNDC": "0093-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acitretin",
"NonProprietaryName": "Acitretin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091455",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ACITRETIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130719",
"SamplePackage": "N",
"IndicationAndUsage": "Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.",
"Description": "Acitretin, USP (micronized), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow crystalline powder. The structural formula is. C21H26O3 M.W. 326.43. Each capsule contains acitretin, USP (micronized) 10 mg, 17.5 mg, and 25 mg. Inactive ingredients are crospovidone, microcrystalline cellulose, poloxamer, povidone, sodium ascorbate and sodium lauryl sulfate. The 10 mg, 17.5, and 25 mg gelatin capsule shells contain gelatin and titanium dioxide. The 10 mg and 25 mg capsule shells also contain D&C yellow no. 10, FD&C blue no. 1, and FD&C red no. 40. The 17.5 mg capsule shells also contain red iron oxide and yellow iron oxide. The 25 mg gelatin capsule shells also contain FD&C yellow no. 6. The edible imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 2."
},
{
"NDCCode": "71335-1136-1",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71335-1136-1) ",
"NDC11Code": "71335-1136-01",
"ProductNDC": "71335-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091541",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .",
"Description": "Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "71335-1136-2",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71335-1136-2) ",
"NDC11Code": "71335-1136-02",
"ProductNDC": "71335-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091541",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190321",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .",
"Description": "Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "71335-1136-3",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71335-1136-3) ",
"NDC11Code": "71335-1136-03",
"ProductNDC": "71335-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091541",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190304",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .",
"Description": "Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "71335-1136-4",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (71335-1136-4) ",
"NDC11Code": "71335-1136-04",
"ProductNDC": "71335-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091541",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .",
"Description": "Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "71335-1136-5",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (71335-1136-5) ",
"NDC11Code": "71335-1136-05",
"ProductNDC": "71335-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091541",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .",
"Description": "Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "71335-1136-6",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE (71335-1136-6) ",
"NDC11Code": "71335-1136-06",
"ProductNDC": "71335-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091541",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .",
"Description": "Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "62106-1100-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (62106-1100-8) > 20 mL in 1 BOTTLE",
"NDC11Code": "62106-1100-08",
"ProductNDC": "62106-1100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 1",
"NonProprietaryName": "Achillea Millefolium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "ACHILLEA MILLEFOLIUM; ARCTOSTAPHYLOS UVA-URSI LEAF; VALERIAN; ANGELICA ARCHANGELICA ROOT; EQUISETUM ARVENSE TOP; LYCOPODIUM CLAVATUM SPORE; LARIX DECIDUA RESIN; SILVER",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 5; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Status": "Active",
"LastUpdate": "2022-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140701",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For the temporary relief of symptoms associated with indigestion fatigue following meals occasional headaches. Directions. Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "62106-1101-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1101-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1101-08",
"ProductNDC": "62106-1101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 2",
"NonProprietaryName": "Petroselinum Sativum, Rhamnus Frangula, Thlaspi Bursa-pastoris, Juniperus Communis, Asparagus Officinalis, Berberis Vulgaris, Genista Tinctoria, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150526",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK; PETROSELINUM CRISPUM; ASPARAGUS; FRANGULA ALNUS BARK; CAPSELLA BURSA-PASTORIS; SILVER; GENISTA TINCTORIA; JUNIPER BERRY",
"StrengthNumber": "4; 4; 4; 4; 4; 12; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1102-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1102-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1102-08",
"ProductNDC": "62106-1102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 3",
"NonProprietaryName": "Equisetum Arvense Stem, Chamomilla, Condurango Bark, Viola Tricolor, Boldo Leaf, Aluminium Metallicum, Stannum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150507",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "EQUISETUM ARVENSE TOP; MATRICARIA RECUTITA; MARSDENIA CONDURANGO BARK; VIOLA TRICOLOR; PEUMUS BOLDUS LEAF; ALUMINUM; TIN",
"StrengthNumber": "4; 4; 4; 4; 4; 12; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150507",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1103-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1103-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1103-08",
"ProductNDC": "62106-1103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 4",
"NonProprietaryName": "Laurus Nobilis, Condurango, Rhamnus Frangula, Menyanthes Trifoliata, Absinthium, Jateorhiza Palmata, Argentum Metallicum, Antimonium Crudum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "FRANGULA ALNUS BARK; MENYANTHES TRIFOLIATA; WORMWOOD; JATEORHIZA CALUMBA ROOT; SILVER; ANTIMONY TRISULFIDE; BAY LEAF; MARSDENIA CONDURANGO BARK",
"StrengthNumber": "4; 4; 4; 4; 12; 12; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1104-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1104-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1104-08",
"ProductNDC": "62106-1104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 5",
"NonProprietaryName": "Tormentilla, Tussilago Farfara, Adiantum Capillus-veneris, Glycyrrhiza Glabra, Drosera, Grindelia, Inula Helenium, Cuprum Metallicum, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "POTENTILLA ERECTA ROOT; ADIANTUM CAPILLUS-VENERIS LEAF; DROSERA ROTUNDIFOLIA FLOWERING TOP; GLYCYRRHIZA GLABRA; GRINDELIA HIRSUTULA FLOWERING TOP; INULA HELENIUM ROOT; COPPER; SILVER; TUSSILAGO FARFARA WHOLE",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 12; 12; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150602",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1105-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1105-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1105-08",
"ProductNDC": "62106-1105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 6",
"NonProprietaryName": "Senna Leaflet, Rhamnus Frangula Bark, Carum Carvi, Foeniculum Vulgare, Illicium Verum, Rhamnus Cathartica, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150526",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "SENNA LEAF; FRANGULA ALNUS BARK; CARAWAY SEED; FENNEL SEED; ILLICIUM VERUM WHOLE; RHAMNUS CATHARTICA FRUIT; SILVER",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1106-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1106-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1106-08",
"ProductNDC": "62106-1106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 7",
"NonProprietaryName": "Equisetum Arvense, Uva-ursi, Juniperus Communis, Cytisus Scoparius, Hieraciumpilosella, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150507",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "HIERACIUM PILOSELLA WHOLE; EQUISETUM ARVENSE TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; JUNIPERUS COMMUNIS WHOLE; CYTISUS SCOPARIUS FLOWERING TOP; SILVER",
"StrengthNumber": "4; 4; 4; 4; 4; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150507",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1107-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1107-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1107-08",
"ProductNDC": "62106-1107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 8",
"NonProprietaryName": "Hamamelis Virginiana, Millefolium, Equisetum Arvense, Mercurialis Perennis, Thlaspi Bursa-pastoris, Cactus Grandiflorus, Crataegus, Cuprum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "HAMAMELIS VIRGINIANA BARK; MERCURIALIS PERENNIS; CRATAEGUS FRUIT; COPPER; ACHILLEA MILLEFOLIUM; EQUISETUM ARVENSE BRANCH; CAPSELLA BURSA-PASTORIS; SELENICEREUS GRANDIFLORUS STEM",
"StrengthNumber": "4; 4; 4; 12; 4; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150602",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1108-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1108-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1108-08",
"ProductNDC": "62106-1108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 9",
"NonProprietaryName": "Mentha Piperita, Melissa Officinalis, Salvia Pratensis, Thymus Vulgaris, Valeriana Officinalis, Aurum Metallicum, Plumbum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150527",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "GOLD; THYMUS VULGARIS WHOLE; VALERIAN; LEAD; MENTHA PIPERITA; SALVIA PRATENSIS LEAF; MELISSA OFFICINALIS",
"StrengthNumber": "12; 4; 4; 12; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150527",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1109-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1109-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1109-08",
"ProductNDC": "62106-1109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 10",
"NonProprietaryName": "Absinthium, Argentum Metallicum, Equisetum Arvense, Juniperus Communis, Millefolium, Rhamnus Frangula",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150929",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "SILVER; EQUISETUM ARVENSE BRANCH; JUNIPER BERRY; WORMWOOD; ACHILLEA MILLEFOLIUM; FRANGULA ALNUS BARK",
"StrengthNumber": "12; 4; 4; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150929",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1110-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1110-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1110-08",
"ProductNDC": "62106-1110",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 11",
"NonProprietaryName": "Asparagus Officinalis Young Shoot, Mentha Piperita Whole Plant, Millefolium Whole Plant,thymus Serpyllum Whole Plant, Crocus Sativus Dried Stigma, Rosmarinus Officinalis Flowering Twigs, Glechoma Hederacea Whole Plant, Verbena Officinalis Whole Plant, Uva-ursi Leaf, Cuprum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150224",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "VERBENA OFFICINALIS; COPPER; ASPARAGUS; GLECHOMA HEDERACEA; ARCTOSTAPHYLOS UVA-URSI LEAF; MENTHA PIPERITA; ACHILLEA MILLEFOLIUM; THYMUS SERPYLLUM; SAFFRON; ROSMARINUS OFFICINALIS FLOWERING TOP",
"StrengthNumber": "4; 12; 4; 4; 4; 4; 4; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150224",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For the temporary relief of minor pain associated with headaches. joints. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years) Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "62106-1112-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (62106-1112-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1112-08",
"ProductNDC": "62106-1112",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 13",
"NonProprietaryName": "Boldo Leaf, Ricinus Communis Seed, Combretum Raimbaultii Leaf, Jateorhiza Palmata Root, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20141217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "SILVER; PEUMUS BOLDUS LEAF; RICINUS COMMUNIS SEED; COMBRETUM MICRANTHUM LEAF; JATEORHIZA CALUMBA ROOT",
"StrengthNumber": "12; 4; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141217",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For the temporary relief of symptoms associated with digestive upset. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years) Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "62106-1113-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1113-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1113-08",
"ProductNDC": "62106-1113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 14",
"NonProprietaryName": "Eucalyptus Globulus, Inula Helenium, Jateorhiza Palmata, Camphora, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "INULA HELENIUM ROOT; JATEORHIZA CALUMBA ROOT; CAMPHOR (NATURAL); SILVER; GOLD; COPPER; EUCALYPTUS GLOBULUS LEAF",
"StrengthNumber": "4; 4; 4; 12; 12; 12; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150602",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1114-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1114-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1114-08",
"ProductNDC": "62106-1114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 15",
"NonProprietaryName": "Allium Cepa, Aurum Metallicum, Eucalyptus Globulus, Inula Helenium, Trigonella Foenum-graecum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150525",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "ONION; GOLD; EUCALYPTUS GLOBULUS LEAF; INULA HELENIUM ROOT; FENUGREEK SEED",
"StrengthNumber": "4; 12; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150525",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1115-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1115-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1115-08",
"ProductNDC": "62106-1115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 16",
"NonProprietaryName": "Saxifraga Granulata, Origanum Vulgare, Lactuca Virosa, Veronica Officinalis, Ajuga Reptans, Drosera, Senega Officinalis, Aurum Metallicum, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150507",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "VERONICA OFFICINALIS FLOWERING TOP; AJUGA REPTANS WHOLE; DROSERA ROTUNDIFOLIA FLOWERING TOP; POLYGALA SENEGA ROOT; GOLD; SAXIFRAGA GRANULATA WHOLE; ORIGANUM VULGARE SUBSP. HIRTUM WHOLE; LACTUCA VIROSA; SILVER",
"StrengthNumber": "4; 4; 4; 4; 12; 4; 4; 4; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150507",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1116-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1116-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1116-08",
"ProductNDC": "62106-1116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 17",
"NonProprietaryName": "Jateorhiza Palmata, Boldo Leaf, Rhamnus Frangula, Scabiosa Succisa Underground Parts, Valeriana Officinalis, Dulcamara, Rumex Crispus, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150206",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "JATEORHIZA CALUMBA ROOT; PEUMUS BOLDUS LEAF; FRANGULA ALNUS BARK; VALERIAN; CHAMAELIRIUM LUTEUM ROOT; SOLANUM DULCAMARA STEM; RUMEX CRISPUS ROOT; SILVER",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 4; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150206",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For the temporary relief of symptom sassociated with mild skin irritation. poor digestion. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "62106-1117-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1117-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1117-08",
"ProductNDC": "62106-1117",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 18",
"NonProprietaryName": "Condurango, Lycopodium Clavatum, Viburnum Prunifolium, Thuja Occidentalis, Camphora, Cuprum Metallicum, Aluminium Metallicum, Stibium Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150206",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "ANTIMONY; MARSDENIA CONDURANGO BARK; VIBURNUM PRUNIFOLIUM BARK; THUJA OCCIDENTALIS LEAFY TWIG; CINNAMOMUM CAMPHORA WHOLE; COPPER; LYCOPODIUM CLAVATUM SPORE; ALUMINUM",
"StrengthNumber": "12; 5; 5; 5; 9; 12; 5; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]",
"Status": "Active",
"LastUpdate": "2022-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150206",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For the temporary relief of symptoms associated with low energy tiredness overall exhaustion. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily, or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "62106-1118-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1118-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1118-08",
"ProductNDC": "62106-1118",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 19",
"NonProprietaryName": "Aluminium Metallicum, Drosera, Illicium Verum, Mentha Piperita, Senega Officinalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170403",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "ALUMINUM; STAR ANISE FRUIT; POLYGALA SENEGA ROOT; DROSERA ROTUNDIFOLIA FLOWERING TOP; PEPPERMINT",
"StrengthNumber": "12; 3; 4; 5; 5",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170403",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For the temporary relief of symptoms associated with minor respiratory problems. Directions. Adults and adolescents (12 years and older) Take 5 drops three times daily or as. recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "62106-1119-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1119-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1119-08",
"ProductNDC": "62106-1119",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 20",
"NonProprietaryName": "Aluminium Metallicum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Calendula Officinalis, Condurango, Jacaranda Caroba, Robinia Pseudoacacia, Sabina",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150525",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "ALUMINUM; SILVER; ARSENIC TRIOXIDE; GOLD; CALENDULA OFFICINALIS FLOWERING TOP; MARSDENIA CONDURANGO BARK; JACARANDA CAROBA LEAF; ROBINIA PSEUDOACACIA BARK; JUNIPERUS SABINA LEAF",
"StrengthNumber": "12; 12; 12; 12; 4; 4; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150525",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1120-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1120-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1120-08",
"ProductNDC": "62106-1120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 21",
"NonProprietaryName": "Condurango, Calendula Officinalis, Camphora, Hydrastis Canadensis, Thuja Occidentalis, Aluminium Metallicum, Aurum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150526",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "MARSDENIA CONDURANGO BARK; CALENDULA OFFICINALIS FLOWERING TOP; CAMPHOR (NATURAL); GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG; ALUMINUM; GOLD",
"StrengthNumber": "4; 4; 4; 4; 4; 12; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1121-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1121-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1121-08",
"ProductNDC": "62106-1121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 22",
"NonProprietaryName": "Absinthium, Aconitum Napellus, Argentum Metallicum, Boldo Leaf, Chamomilla, Coffea Tosta, Jateorhiza Palmata, Manganum Oxydatum Nigrum, Salvia Officinalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150921",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "MANGANESE DIOXIDE; SAGE; PEUMUS BOLDUS LEAF; MATRICARIA RECUTITA; JATEORHIZA CALUMBA ROOT; WORMWOOD; ACONITUM NAPELLUS; SILVER; COFFEA ARABICA SEED, ROASTED",
"StrengthNumber": "12; 4; 4; 4; 4; 4; 4; 12; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150921",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
<NDCCode>62106-1136-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1136-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1136-08</NDC11Code>
<ProductNDC>62106-1136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 37</ProprietaryName>
<NonProprietaryName>Petroselinum Sativum, Calendula Officinalis, Dulcamara, Lycopodium Clavatum, Hypericum Perforatum, Aurum Metallicum, Argentummetallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150116</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>SOLANUM DULCAMARA STEM; HYPERICUM PERFORATUM; GOLD; PETROSELINUM CRISPUM; CALENDULA OFFICINALIS FLOWERING TOP; SILVER; LYCOPODIUM CLAVATUM SPORE</SubstanceName>
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<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptoms associated with minor inflammation. Directions Adults and adolescents (12 years and older) Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70771-1136-8</NDCCode>
<PackageDescription>16 CAPSULE, GELATIN COATED in 1 BOTTLE (70771-1136-8) </PackageDescription>
<NDC11Code>70771-1136-08</NDC11Code>
<ProductNDC>70771-1136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065217</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0093-1136-56</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0093-1136-56) </PackageDescription>
<NDC11Code>00093-1136-56</NDC11Code>
<ProductNDC>0093-1136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acitretin</ProprietaryName>
<NonProprietaryName>Acitretin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091455</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ACITRETIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.</IndicationAndUsage>
<Description>Acitretin, USP (micronized), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow crystalline powder. The structural formula is. C21H26O3 M.W. 326.43. Each capsule contains acitretin, USP (micronized) 10 mg, 17.5 mg, and 25 mg. Inactive ingredients are crospovidone, microcrystalline cellulose, poloxamer, povidone, sodium ascorbate and sodium lauryl sulfate. The 10 mg, 17.5, and 25 mg gelatin capsule shells contain gelatin and titanium dioxide. The 10 mg and 25 mg capsule shells also contain D&C yellow no. 10, FD&C blue no. 1, and FD&C red no. 40. The 17.5 mg capsule shells also contain red iron oxide and yellow iron oxide. The 25 mg gelatin capsule shells also contain FD&C yellow no. 6. The edible imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>71335-1136-1</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71335-1136-1) </PackageDescription>
<NDC11Code>71335-1136-01</NDC11Code>
<ProductNDC>71335-1136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091541</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .</IndicationAndUsage>
<Description>Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>71335-1136-2</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71335-1136-2) </PackageDescription>
<NDC11Code>71335-1136-02</NDC11Code>
<ProductNDC>71335-1136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091541</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .</IndicationAndUsage>
<Description>Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>71335-1136-3</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71335-1136-3) </PackageDescription>
<NDC11Code>71335-1136-03</NDC11Code>
<ProductNDC>71335-1136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091541</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .</IndicationAndUsage>
<Description>Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>71335-1136-4</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (71335-1136-4) </PackageDescription>
<NDC11Code>71335-1136-04</NDC11Code>
<ProductNDC>71335-1136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091541</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .</IndicationAndUsage>
<Description>Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .</IndicationAndUsage>
<Description>Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .</IndicationAndUsage>
<Description>Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
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<ProductNDC>62106-1100</ProductNDC>
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<ProprietaryName>Unda 1</ProprietaryName>
<NonProprietaryName>Achillea Millefolium</NonProprietaryName>
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<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>ACHILLEA MILLEFOLIUM; ARCTOSTAPHYLOS UVA-URSI LEAF; VALERIAN; ANGELICA ARCHANGELICA ROOT; EQUISETUM ARVENSE TOP; LYCOPODIUM CLAVATUM SPORE; LARIX DECIDUA RESIN; SILVER</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2022-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptoms associated with indigestion fatigue following meals occasional headaches. Directions. Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1101-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1101-08</NDC11Code>
<ProductNDC>62106-1101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Petroselinum Sativum, Rhamnus Frangula, Thlaspi Bursa-pastoris, Juniperus Communis, Asparagus Officinalis, Berberis Vulgaris, Genista Tinctoria, Argentum Metallicum</NonProprietaryName>
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<SubstanceName>BERBERIS VULGARIS ROOT BARK; PETROSELINUM CRISPUM; ASPARAGUS; FRANGULA ALNUS BARK; CAPSELLA BURSA-PASTORIS; SILVER; GENISTA TINCTORIA; JUNIPER BERRY</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 12; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1102-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1102-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1102-08</NDC11Code>
<ProductNDC>62106-1102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 3</ProprietaryName>
<NonProprietaryName>Equisetum Arvense Stem, Chamomilla, Condurango Bark, Viola Tricolor, Boldo Leaf, Aluminium Metallicum, Stannum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>EQUISETUM ARVENSE TOP; MATRICARIA RECUTITA; MARSDENIA CONDURANGO BARK; VIOLA TRICOLOR; PEUMUS BOLDUS LEAF; ALUMINUM; TIN</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1103-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1103-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1103-08</NDC11Code>
<ProductNDC>62106-1103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 4</ProprietaryName>
<NonProprietaryName>Laurus Nobilis, Condurango, Rhamnus Frangula, Menyanthes Trifoliata, Absinthium, Jateorhiza Palmata, Argentum Metallicum, Antimonium Crudum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>FRANGULA ALNUS BARK; MENYANTHES TRIFOLIATA; WORMWOOD; JATEORHIZA CALUMBA ROOT; SILVER; ANTIMONY TRISULFIDE; BAY LEAF; MARSDENIA CONDURANGO BARK</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 12; 12; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1104-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1104-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1104-08</NDC11Code>
<ProductNDC>62106-1104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 5</ProprietaryName>
<NonProprietaryName>Tormentilla, Tussilago Farfara, Adiantum Capillus-veneris, Glycyrrhiza Glabra, Drosera, Grindelia, Inula Helenium, Cuprum Metallicum, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
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<StartMarketingDate>20150602</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>POTENTILLA ERECTA ROOT; ADIANTUM CAPILLUS-VENERIS LEAF; DROSERA ROTUNDIFOLIA FLOWERING TOP; GLYCYRRHIZA GLABRA; GRINDELIA HIRSUTULA FLOWERING TOP; INULA HELENIUM ROOT; COPPER; SILVER; TUSSILAGO FARFARA WHOLE</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 4; 12; 12; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1105-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1105-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1105-08</NDC11Code>
<ProductNDC>62106-1105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 6</ProprietaryName>
<NonProprietaryName>Senna Leaflet, Rhamnus Frangula Bark, Carum Carvi, Foeniculum Vulgare, Illicium Verum, Rhamnus Cathartica, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
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<StartMarketingDate>20150526</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>SENNA LEAF; FRANGULA ALNUS BARK; CARAWAY SEED; FENNEL SEED; ILLICIUM VERUM WHOLE; RHAMNUS CATHARTICA FRUIT; SILVER</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 4; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1106-8</NDCCode>
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<ProductNDC>62106-1106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 7</ProprietaryName>
<NonProprietaryName>Equisetum Arvense, Uva-ursi, Juniperus Communis, Cytisus Scoparius, Hieraciumpilosella, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
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<StartMarketingDate>20150507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>HIERACIUM PILOSELLA WHOLE; EQUISETUM ARVENSE TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; JUNIPERUS COMMUNIS WHOLE; CYTISUS SCOPARIUS FLOWERING TOP; SILVER</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<NDC11Code>62106-1107-08</NDC11Code>
<ProductNDC>62106-1107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 8</ProprietaryName>
<NonProprietaryName>Hamamelis Virginiana, Millefolium, Equisetum Arvense, Mercurialis Perennis, Thlaspi Bursa-pastoris, Cactus Grandiflorus, Crataegus, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150602</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>HAMAMELIS VIRGINIANA BARK; MERCURIALIS PERENNIS; CRATAEGUS FRUIT; COPPER; ACHILLEA MILLEFOLIUM; EQUISETUM ARVENSE BRANCH; CAPSELLA BURSA-PASTORIS; SELENICEREUS GRANDIFLORUS STEM</SubstanceName>
<StrengthNumber>4; 4; 4; 12; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1108-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1108-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1108-08</NDC11Code>
<ProductNDC>62106-1108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 9</ProprietaryName>
<NonProprietaryName>Mentha Piperita, Melissa Officinalis, Salvia Pratensis, Thymus Vulgaris, Valeriana Officinalis, Aurum Metallicum, Plumbum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150527</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>GOLD; THYMUS VULGARIS WHOLE; VALERIAN; LEAD; MENTHA PIPERITA; SALVIA PRATENSIS LEAF; MELISSA OFFICINALIS</SubstanceName>
<StrengthNumber>12; 4; 4; 12; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1109-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1109-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1109-08</NDC11Code>
<ProductNDC>62106-1109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 10</ProprietaryName>
<NonProprietaryName>Absinthium, Argentum Metallicum, Equisetum Arvense, Juniperus Communis, Millefolium, Rhamnus Frangula</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150929</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>SILVER; EQUISETUM ARVENSE BRANCH; JUNIPER BERRY; WORMWOOD; ACHILLEA MILLEFOLIUM; FRANGULA ALNUS BARK</SubstanceName>
<StrengthNumber>12; 4; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1110-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1110-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1110-08</NDC11Code>
<ProductNDC>62106-1110</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 11</ProprietaryName>
<NonProprietaryName>Asparagus Officinalis Young Shoot, Mentha Piperita Whole Plant, Millefolium Whole Plant,thymus Serpyllum Whole Plant, Crocus Sativus Dried Stigma, Rosmarinus Officinalis Flowering Twigs, Glechoma Hederacea Whole Plant, Verbena Officinalis Whole Plant, Uva-ursi Leaf, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150224</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>VERBENA OFFICINALIS; COPPER; ASPARAGUS; GLECHOMA HEDERACEA; ARCTOSTAPHYLOS UVA-URSI LEAF; MENTHA PIPERITA; ACHILLEA MILLEFOLIUM; THYMUS SERPYLLUM; SAFFRON; ROSMARINUS OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>4; 12; 4; 4; 4; 4; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For the temporary relief of minor pain associated with headaches. joints. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years) Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1112-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (62106-1112-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1112-08</NDC11Code>
<ProductNDC>62106-1112</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 13</ProprietaryName>
<NonProprietaryName>Boldo Leaf, Ricinus Communis Seed, Combretum Raimbaultii Leaf, Jateorhiza Palmata Root, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141217</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>SILVER; PEUMUS BOLDUS LEAF; RICINUS COMMUNIS SEED; COMBRETUM MICRANTHUM LEAF; JATEORHIZA CALUMBA ROOT</SubstanceName>
<StrengthNumber>12; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptoms associated with digestive upset. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years) Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1113-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1113-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1113-08</NDC11Code>
<ProductNDC>62106-1113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 14</ProprietaryName>
<NonProprietaryName>Eucalyptus Globulus, Inula Helenium, Jateorhiza Palmata, Camphora, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150602</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>INULA HELENIUM ROOT; JATEORHIZA CALUMBA ROOT; CAMPHOR (NATURAL); SILVER; GOLD; COPPER; EUCALYPTUS GLOBULUS LEAF</SubstanceName>
<StrengthNumber>4; 4; 4; 12; 12; 12; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1114-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1114-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1114-08</NDC11Code>
<ProductNDC>62106-1114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 15</ProprietaryName>
<NonProprietaryName>Allium Cepa, Aurum Metallicum, Eucalyptus Globulus, Inula Helenium, Trigonella Foenum-graecum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150525</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>ONION; GOLD; EUCALYPTUS GLOBULUS LEAF; INULA HELENIUM ROOT; FENUGREEK SEED</SubstanceName>
<StrengthNumber>4; 12; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1115-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1115-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1115-08</NDC11Code>
<ProductNDC>62106-1115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 16</ProprietaryName>
<NonProprietaryName>Saxifraga Granulata, Origanum Vulgare, Lactuca Virosa, Veronica Officinalis, Ajuga Reptans, Drosera, Senega Officinalis, Aurum Metallicum, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>VERONICA OFFICINALIS FLOWERING TOP; AJUGA REPTANS WHOLE; DROSERA ROTUNDIFOLIA FLOWERING TOP; POLYGALA SENEGA ROOT; GOLD; SAXIFRAGA GRANULATA WHOLE; ORIGANUM VULGARE SUBSP. HIRTUM WHOLE; LACTUCA VIROSA; SILVER</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 12; 4; 4; 4; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1116-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1116-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1116-08</NDC11Code>
<ProductNDC>62106-1116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 17</ProprietaryName>
<NonProprietaryName>Jateorhiza Palmata, Boldo Leaf, Rhamnus Frangula, Scabiosa Succisa Underground Parts, Valeriana Officinalis, Dulcamara, Rumex Crispus, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150206</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>JATEORHIZA CALUMBA ROOT; PEUMUS BOLDUS LEAF; FRANGULA ALNUS BARK; VALERIAN; CHAMAELIRIUM LUTEUM ROOT; SOLANUM DULCAMARA STEM; RUMEX CRISPUS ROOT; SILVER</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 4; 4; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptom sassociated with mild skin irritation. poor digestion. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1117-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1117-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1117-08</NDC11Code>
<ProductNDC>62106-1117</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 18</ProprietaryName>
<NonProprietaryName>Condurango, Lycopodium Clavatum, Viburnum Prunifolium, Thuja Occidentalis, Camphora, Cuprum Metallicum, Aluminium Metallicum, Stibium Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150206</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>ANTIMONY; MARSDENIA CONDURANGO BARK; VIBURNUM PRUNIFOLIUM BARK; THUJA OCCIDENTALIS LEAFY TWIG; CINNAMOMUM CAMPHORA WHOLE; COPPER; LYCOPODIUM CLAVATUM SPORE; ALUMINUM</SubstanceName>
<StrengthNumber>12; 5; 5; 5; 9; 12; 5; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptoms associated with low energy tiredness overall exhaustion. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily, or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1118-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1118-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1118-08</NDC11Code>
<ProductNDC>62106-1118</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 19</ProprietaryName>
<NonProprietaryName>Aluminium Metallicum, Drosera, Illicium Verum, Mentha Piperita, Senega Officinalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170403</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>ALUMINUM; STAR ANISE FRUIT; POLYGALA SENEGA ROOT; DROSERA ROTUNDIFOLIA FLOWERING TOP; PEPPERMINT</SubstanceName>
<StrengthNumber>12; 3; 4; 5; 5</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptoms associated with minor respiratory problems. Directions. Adults and adolescents (12 years and older) Take 5 drops three times daily or as. recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1119-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1119-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1119-08</NDC11Code>
<ProductNDC>62106-1119</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 20</ProprietaryName>
<NonProprietaryName>Aluminium Metallicum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Calendula Officinalis, Condurango, Jacaranda Caroba, Robinia Pseudoacacia, Sabina</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150525</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>ALUMINUM; SILVER; ARSENIC TRIOXIDE; GOLD; CALENDULA OFFICINALIS FLOWERING TOP; MARSDENIA CONDURANGO BARK; JACARANDA CAROBA LEAF; ROBINIA PSEUDOACACIA BARK; JUNIPERUS SABINA LEAF</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 4; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1120-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1120-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1120-08</NDC11Code>
<ProductNDC>62106-1120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 21</ProprietaryName>
<NonProprietaryName>Condurango, Calendula Officinalis, Camphora, Hydrastis Canadensis, Thuja Occidentalis, Aluminium Metallicum, Aurum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150526</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>MARSDENIA CONDURANGO BARK; CALENDULA OFFICINALIS FLOWERING TOP; CAMPHOR (NATURAL); GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG; ALUMINUM; GOLD</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1121-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1121-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1121-08</NDC11Code>
<ProductNDC>62106-1121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 22</ProprietaryName>
<NonProprietaryName>Absinthium, Aconitum Napellus, Argentum Metallicum, Boldo Leaf, Chamomilla, Coffea Tosta, Jateorhiza Palmata, Manganum Oxydatum Nigrum, Salvia Officinalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150921</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>MANGANESE DIOXIDE; SAGE; PEUMUS BOLDUS LEAF; MATRICARIA RECUTITA; JATEORHIZA CALUMBA ROOT; WORMWOOD; ACONITUM NAPELLUS; SILVER; COFFEA ARABICA SEED, ROASTED</SubstanceName>
<StrengthNumber>12; 4; 4; 4; 4; 4; 4; 12; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>