{
"NDC": [
{
"NDCCode": "63776-605-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-605-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0605-14",
"ProductNDC": "63776-605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaldehyde",
"NonProprietaryName": "Acetaldehyde",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACETALDEHYDE",
"StrengthNumber": "200",
"StrengthUnit": "{kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To help with symptoms of leaky gut & food sensitivies."
},
{
"NDCCode": "10544-605-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (10544-605-14)",
"NDC11Code": "10544-0605-14",
"ProductNDC": "10544-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075817",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "CIPROFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.",
"Description": "Ciprofloxacin tablet, USP is a synthetic broad spectrum antimicrobial agent for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3 HCl H2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg or 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets are white. The inactive ingredients are: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide and triacetin."
},
{
"NDCCode": "12634-605-54",
"PackageDescription": "14 TABLET in 1 BLISTER PACK (12634-605-54)",
"NDC11Code": "12634-0605-54",
"ProductNDC": "12634-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076900",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol may be administered with other antihypertensive agents.",
"Description": "Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor-blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:. Atenolol, USP has a molecular weight of 266. It is a white or almost white powder, sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether. Atenolol tablets, for oral administration, are available as 25 mg, 50 mg and 100 mg tablets. Inactive Ingredients: Citric acid (anhydrous), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone."
},
{
"NDCCode": "12634-605-84",
"PackageDescription": "14 TABLET in 1 BOTTLE (12634-605-84)",
"NDC11Code": "12634-0605-84",
"ProductNDC": "12634-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076900",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol may be administered with other antihypertensive agents.",
"Description": "Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor-blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:. Atenolol, USP has a molecular weight of 266. It is a white or almost white powder, sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether. Atenolol tablets, for oral administration, are available as 25 mg, 50 mg and 100 mg tablets. Inactive Ingredients: Citric acid (anhydrous), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone."
},
{
"NDCCode": "37000-605-14",
"PackageDescription": "414 mL in 1 BOTTLE, PLASTIC (37000-605-14)",
"NDC11Code": "37000-0605-14",
"ProductNDC": "37000-605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dawn",
"ProprietaryNameSuffix": "Ultra Concentrated Apple Blossom",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110201",
"EndMarketingDate": "20151019",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Procter & Gamble Manufacturing Company",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "40051-605-12",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, PLASTIC (40051-605-12)",
"NDC11Code": "40051-0605-12",
"ProductNDC": "40051-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206309",
"LabelerName": "Lotus Pharmaceutical Co., Ltd.Nantou Plant",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-05-31"
},
{
"NDCCode": "40051-605-52",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, GLASS (40051-605-52)",
"NDC11Code": "40051-0605-52",
"ProductNDC": "40051-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206309",
"LabelerName": "Lotus Pharmaceutical Co., Ltd.Nantou Plant",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-05-31"
},
{
"NDCCode": "43598-605-56",
"PackageDescription": "14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE",
"NDC11Code": "43598-0605-56",
"ProductNDC": "43598-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin Inhalation Solution",
"NonProprietaryName": "Tobramycin Inhalation Solution",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20190514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207080",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190514",
"SamplePackage": "N",
"IndicationAndUsage": "Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].",
"Description": "Tobramycin inhalation solution, USP is a tobramycin solution for inhalation. It is a sterile, clear, colorless to slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52 g/mol. Tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin USP is. Each single-dose 5 mL ampule contains 300 mg tobramycin, USP and 11.25 mg sodium chloride in sterile water for injection. Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0. Nitrogen is used for sparging. All ingredients meet USP requirements. The formulation contains no preservatives."
},
{
"NDCCode": "50157-605-14",
"PackageDescription": "1480 mL in 1 BOTTLE, PUMP (50157-605-14) ",
"NDC11Code": "50157-0605-14",
"ProductNDC": "50157-605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial",
"ProprietaryNameSuffix": "Spring Rain",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221114",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Brands International Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/1000mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221114",
"SamplePackage": "N",
"IndicationAndUsage": "Use for handwashing to decrease bacteria on skin."
},
{
"NDCCode": "62257-605-14",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (62257-605-14)",
"NDC11Code": "62257-0605-14",
"ProductNDC": "62257-605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcogel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070427",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "ABC Compounding Co., Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin, only when water is not available."
},
{
"NDCCode": "65841-605-14",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (65841-605-14) ",
"NDC11Code": "65841-0605-14",
"ProductNDC": "65841-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079017",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230405",
"SamplePackage": "N"
},
{
"NDCCode": "71205-605-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-14) ",
"NDC11Code": "71205-0605-14",
"ProductNDC": "71205-605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081297",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2022-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210915",
"SamplePackage": "N",
"IndicationAndUsage": "BENZONATATE is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water."
},
{
"NDCCode": "75990-605-14",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (75990-605-14) ",
"NDC11Code": "75990-0605-14",
"ProductNDC": "75990-605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Recens",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110519",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Certus Medical, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110519",
"SamplePackage": "N"
},
{
"NDCCode": "83318-605-14",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (83318-605-14) ",
"NDC11Code": "83318-0605-14",
"ProductNDC": "83318-605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Plus Brasept Alcocol Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230324",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "NEWDROP NORTH AMERICA LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230324",
"SamplePackage": "N",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin, only when water is not available."
},
{
"NDCCode": "84126-605-14",
"PackageDescription": "147 mL in 1 TUBE (84126-605-14) ",
"NDC11Code": "84126-0605-14",
"ProductNDC": "84126-605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Native Mineral Sunscreen Broad Spectrum Spf 30 Tropical Breeze",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "63776-027-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-027-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0027-14",
"ProductNDC": "63776-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aller Balance",
"NonProprietaryName": "Acetylcholine Chloride, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Epinephrine, Onion, Ammonium Carbonate, Apis Mellifera, Arsenic Trioxide, Histamine, Interferon Gamma-1a, Interleukin-12 Human, Manganese Gluconate, Luffa Operculata Fruit, Sus Scrofa Lung, Beef Lung, Sus Scrofa Nasal Mucosa, Bos Taurus Nasal Mucosa, Sodium Chloride, Bos Taurus Peyers Patch, Sus Scrofa Peyers Patch, Schoenocaulon Officinale Seed, Serotonin, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACETYLCHOLINE CHLORIDE; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; EPINEPHRINE; ONION; AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; MANGANESE GLUCONATE; LUFFA OPERCULATA FRUIT; SUS SCROFA LUNG; BEEF LUNG; SUS SCROFA NASAL MUCOSA; BOS TAURUS NASAL MUCOSA; SODIUM CHLORIDE; BOS TAURUS PEYER'S PATCH; SUS SCROFA PEYER'S PATCH; SCHOENOCAULON OFFICINALE SEED; SEROTONIN; BOS TAURUS THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "200; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 4; 30; 200; 200; 200; 200; 200; 30; 30; 200; 200; 200; 200",
"StrengthUnit": "{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "63776-033-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-033-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0033-14",
"ProductNDC": "63776-033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ans/cns",
"NonProprietaryName": "Acetylcholine Chloride, Epinephrine, .gamma.-aminobutyric Acid, Histamine, Goldenseal, Norepinephrine, Taraxacum Palustre Root, Tyramine",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACETYLCHOLINE CHLORIDE; EPINEPHRINE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE; GOLDENSEAL; NOREPINEPHRINE; TARAXACUM PALUSTRE ROOT; TYRAMINE",
"StrengthNumber": "200; 200; 200; 200; 3; 200; 30; 200",
"StrengthUnit": "{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-035-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-035-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0035-14",
"ProductNDC": "63776-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthros",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": ".ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; ASCORBIC ACID; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS CARTILAGE; BOS TAURUS JOINT CAPSULE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PLACENTA; BOS TAURUS RED BLOOD CELL; BOS TAURUS SOLAR PLEXUS; BOS TAURUS VEIN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CALCITONIN; COLCHICUM AUTUMNALE BULB; EDODEKIN ALFA; ERSOFERMIN; INTERFERON GAMMA-1A; METENKEFALIN; NADIDE; PORK COLLAGEN; PORK LIVER; QUINHYDRONE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA CARTILAGE; SUS SCROFA JOINT CAPSULE; SUS SCROFA LYMPH; SUS SCROFA MESENCHYME; SUS SCROFA PARATHYROID GLAND; SUS SCROFA RED BLOOD CELL; SUS SCROFA SOLAR PLEXUS; SUS SCROFA VEIN",
"StrengthNumber": "30; 30; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dopamine Agonists [MoA], Dopaminergic Agonist [EPC], Increased Histamine Release [PE], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of arthritic symptoms."
},
{
"NDCCode": "63776-037-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-037-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0037-14",
"ProductNDC": "63776-037",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Articula",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Bos Taurus Ankle Joint, Sus Scrofa Ankle Joint, Metenkefalin, Ersofermin, Bos Taurus Achilles Tendon, Sus Scrofa Achilles Tendon, Bos Taurus Hip Joint, Sus Scrofa Hip Joint, Bos Taurus Knee Joint, Sus Scrofa Knee Joint, Beef Liver, Pork Liver, Transforming Growth Factor Beta-1, Avotermin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; AVOTERMIN; BEEF LIVER; BOS TAURUS ACHILLES TENDON; BOS TAURUS ANKLE JOINT; BOS TAURUS HIP JOINT; BOS TAURUS KNEE JOINT; ERSOFERMIN; METENKEFALIN; PORK LIVER; SUS SCROFA ACHILLES TENDON; SUS SCROFA ANKLE JOINT; SUS SCROFA HIP JOINT; SUS SCROFA KNEE JOINT; TRANSFORMING GROWTH FACTOR BETA-1",
"StrengthNumber": "200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120526",
"SamplePackage": "N",
"IndicationAndUsage": "To help support the repair & regeneration of articulations & joints."
},
{
"NDCCode": "63776-073-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-073-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0073-14",
"ProductNDC": "63776-073",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida",
"NonProprietaryName": "Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Penicillin G Sodium, Vaccinium Vitis-idaea Leaf",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; YEAST MANNAN; PENICILLIN G SODIUM; VACCINIUM VITIS-IDAEA LEAF",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200; 200; 200; 200",
"StrengthUnit": "{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "63776-074-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-074-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0074-14",
"ProductNDC": "63776-074",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida Plus",
"NonProprietaryName": "Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Vaccinium Vitis-idaea Leaf",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200; 200; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms due to Candida, including precursors and byproducts."
},
{
"NDCCode": "63776-075-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-075-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0075-14",
"ProductNDC": "63776-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida I",
"NonProprietaryName": "Caffeic Acid, Candida Albicans, Tanacetum Parthenium, Centella Asiatica, Yeast Mannan, Penicillin G, Vaccinium Vitis-idaea Leaf Spray",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "CAFFEIC ACID; CANDIDA ALBICANS; TANACETUM PARTHENIUM; CENTELLA ASIATICA; YEAST MANNAN; PENICILLIN G; VACCINIUM VITIS-IDAEA LEAF",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200",
"StrengthUnit": "{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-081-14",
"PackageDescription": "30 mL in 1 BOTTLE (63776-081-14) ",
"NDC11Code": "63776-0081-14",
"ProductNDC": "63776-081",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-cellulite",
"NonProprietaryName": "Androsterone, Artichoke, Atp, Bfgf, Camp, L-carnitine, Centella Asiatica, Citric Acid, Cobalt, Estrogen, Ferrum Fumaricum, Fumaric Acid, Ginkgo, Hamamelis, Hyaluronidase, Il-3, Kalium Asparticum, Lactic Acid, Lymphatic Vessel, Melilotus, Mn, Natrum Oxalaceticum, Natrum Pyruvicum, Quinhydrone, Succinic Acid, Vein, Vitamin A And Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; ADENOSINE TRIPHOSPHATE; ANDROSTERONE; ARTICHOKE; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BOS TAURUS LYMPH VESSEL; BOS TAURUS VEIN; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COBALT; ERSOFERMIN; ESTROGENS, ESTERIFIED; FERROUS FUMARATE; FUMARIC ACID; HAMAMELIS VIRGINIANA BARK; HEPTAMINOL; HYALURONIDASE; INTERLEUKIN-3; LACTIC ACID; LEVOCARNITINE; MANGANESE; MELILOTUS OFFICINALIS WHOLE; POTASSIUM ASPARTATE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA LYMPH VESSEL; SUS SCROFA VEIN; VITAMIN A; ZINC",
"StrengthNumber": "30; 30; 30; 30; 200; 200; 200; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Acidifying Activity [MoA], Allergens [CS], Allergens [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Carnitine Analog [EPC], Carnitine [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS], Vitamin A [CS], Vitamin A [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210224",
"SamplePackage": "N",
"IndicationAndUsage": "Cellulite drainage & tonification, metabolism and lipid balance, hormonal support, circulatory support and regeneration."
},
{
"NDCCode": "63776-095-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-095-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0095-14",
"ProductNDC": "63776-095",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Collagen",
"NonProprietaryName": "Pork Collagen",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "PORK COLLAGEN",
"StrengthNumber": "200",
"StrengthUnit": "[kp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "To help support collagen formation."
},
{
"NDCCode": "63776-100-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-100-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0100-14",
"ProductNDC": "63776-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Connectissue",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Ascorbic Acid, Metenkefalin, Ersofermin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Interleukin-3, Interleukin-3, Beef Liver, Pork Liver, Beef, Pork, Bos Taurus Tendon, Sus Scrofa Tendon, Cetermin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ASCORBIC ACID; BEEF; BEEF LIVER; BOS TAURUS CARTILAGE; BOS TAURUS RED BLOOD CELL; BOS TAURUS TENDON; CETERMIN; ERSOFERMIN; INTERLEUKIN-3; METENKEFALIN; PORK; PORK COLLAGEN; PORK LIVER; SUS SCROFA CARTILAGE; SUS SCROFA RED BLOOD CELL; SUS SCROFA TENDON",
"StrengthNumber": "200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Meat Proteins [EXT], Meat Proteins [EXT], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120326",
"SamplePackage": "N",
"IndicationAndUsage": "To help support the repair & regeneration of connective tissue & cartilage."
},
{
"NDCCode": "63776-102-14",
"PackageDescription": "30 mL in 1 BOTTLE (63776-102-14) ",
"NDC11Code": "63776-0102-14",
"ProductNDC": "63776-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-mesenchyme",
"NonProprietaryName": "Adrenal, Ascorbic Acid, Bdnf, Dhea, Malic Acid, Bfgf, Fucus Vesiculosus, Histidine, Hyaluronidase, Il-6, Lactic Acid, Lymph Node, Mesenchyme, Nad, Natrum Oxalaceticum, Natrum Pyruvicum, Natrum Sulphuricum, Phenylalanine, Amino Acid, Pyrogenium, Thuja Occidentalis, Trichinoyl, Tyrosine",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; FUCUS VESICULOSUS; HISTIDINE; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); HYALURONIDASE; LACTIC ACID; MALIC ACID; NADIDE; PHENYLALANINE; PRASTERONE; PROLACTIN; RANCID BEEF; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA MESENCHYME; THUJA OCCIDENTALIS LEAF; TYROSINE",
"StrengthNumber": "30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30; 200; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Ascorbic Acid [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N",
"IndicationAndUsage": "To help encourage extra cellular / matrix / connective tissue drainage & support.",
"Description": "Viatrexx-Mesenchyme is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system."
},
{
"NDCCode": "63776-142-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-142-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0142-14",
"ProductNDC": "63776-142",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-enzyme Plus",
"NonProprietaryName": "Amylase, Cellulase, Lactase, Lipase, Maltase, Protease, Sucrase",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "CELLULASE (TRICHODERMA LONGIBRACHIATUM); LACTASE; LYSOSOMAL ALPHA-GLUCOSIDASE; PANCREATIC ALPHA-AMYLASE; PANCREATIC TRIACYLGLYCEROL LIPASE; PANCRELIPASE PROTEASE; SACROSIDASE",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Sucrose-specific Enzyme [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190705",
"SamplePackage": "N",
"IndicationAndUsage": "To support healthy digestion.",
"Description": "Viatrexx-Enzyme + is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system."
},
{
"NDCCode": "63776-165-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-165-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0165-14",
"ProductNDC": "63776-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foods",
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"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
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"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 1; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 1; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Egg Proteins, Dietary [CS], Fish Proteins, Dietary [EXT], Fish Proteins, Dietary [EXT], Fish Proteins, Dietary [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "To help with sensitivities to common foods."
},
{
"NDCCode": "63776-170-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-170-14) > 30 mL in 1 BOTTLE, SPRAY",
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"ProductNDC": "63776-170",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Female",
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"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; CHOLESTEROL; SUS SCROFA CORPUS LUTEUM; ESTROGENS, ESTERIFIED; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; MELATONIN; BOS TAURUS OVARY; SUS SCROFA OVARY; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS PINEAL GLAND; SUS SCROFA PINEAL GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; PROGESTERONE; SUS SCROFA THALAMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200",
"StrengthUnit": "{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-175-14",
"PackageDescription": "30 mL in 1 BOTTLE (63776-175-14) ",
"NDC11Code": "63776-0175-14",
"ProductNDC": "63776-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-f Gus",
"NonProprietaryName": "Berberis, Cochlerearia Armor, Echinacea, Ferrum, Hydrastis, Iridium, Lapacho, Lomatium, Lycopodium, Myrrh, Phosporicum Acidum, Propolis, Pulsatilla, Seleneium, Thymus, Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANEMONE PULSATILLA; ARMORACIA RUSTICANA WHOLE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS THYMUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HANDROANTHUS IMPETIGINOSUS WHOLE; IRIDIUM; IRON; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHOSPHORIC ACID; PROPOLIS WAX; SELENIUM; SUS SCROFA THYMUS; ZINC",
"StrengthNumber": "12; 3; 3; 6; 3; 3; 3; 12; 12; 3; 12; 3; 12; 3; 12; 6; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210224",
"SamplePackage": "N",
"IndicationAndUsage": "nutritional support for fungal, mold, bacteria challenges.",
"Description": "Viatrexx-F gus is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system."
}
]
}
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<NDCList>
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<NDCCode>63776-605-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-605-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0605-14</NDC11Code>
<ProductNDC>63776-605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaldehyde</ProprietaryName>
<NonProprietaryName>Acetaldehyde</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACETALDEHYDE</SubstanceName>
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<StrengthUnit>{kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To help with symptoms of leaky gut & food sensitivies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10544-605-14</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (10544-605-14)</PackageDescription>
<NDC11Code>10544-0605-14</NDC11Code>
<ProductNDC>10544-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075817</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.</IndicationAndUsage>
<Description>Ciprofloxacin tablet, USP is a synthetic broad spectrum antimicrobial agent for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3 HCl H2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg or 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets are white. The inactive ingredients are: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
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<PackageDescription>14 TABLET in 1 BLISTER PACK (12634-605-54)</PackageDescription>
<NDC11Code>12634-0605-54</NDC11Code>
<ProductNDC>12634-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076900</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor-blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:. Atenolol, USP has a molecular weight of 266. It is a white or almost white powder, sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether. Atenolol tablets, for oral administration, are available as 25 mg, 50 mg and 100 mg tablets. Inactive Ingredients: Citric acid (anhydrous), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-605-84</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (12634-605-84)</PackageDescription>
<NDC11Code>12634-0605-84</NDC11Code>
<ProductNDC>12634-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076900</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor-blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:. Atenolol, USP has a molecular weight of 266. It is a white or almost white powder, sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether. Atenolol tablets, for oral administration, are available as 25 mg, 50 mg and 100 mg tablets. Inactive Ingredients: Citric acid (anhydrous), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone.</Description>
</NDC>
<NDC>
<NDCCode>37000-605-14</NDCCode>
<PackageDescription>414 mL in 1 BOTTLE, PLASTIC (37000-605-14)</PackageDescription>
<NDC11Code>37000-0605-14</NDC11Code>
<ProductNDC>37000-605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dawn</ProprietaryName>
<ProprietaryNameSuffix>Ultra Concentrated Apple Blossom</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<EndMarketingDate>20151019</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>40051-605-12</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE, PLASTIC (40051-605-12)</PackageDescription>
<NDC11Code>40051-0605-12</NDC11Code>
<ProductNDC>40051-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206309</ApplicationNumber>
<LabelerName>Lotus Pharmaceutical Co., Ltd.Nantou Plant</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-31</LastUpdate>
</NDC>
<NDC>
<NDCCode>40051-605-52</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE, GLASS (40051-605-52)</PackageDescription>
<NDC11Code>40051-0605-52</NDC11Code>
<ProductNDC>40051-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206309</ApplicationNumber>
<LabelerName>Lotus Pharmaceutical Co., Ltd.Nantou Plant</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-31</LastUpdate>
</NDC>
<NDC>
<NDCCode>43598-605-56</NDCCode>
<PackageDescription>14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE</PackageDescription>
<NDC11Code>43598-0605-56</NDC11Code>
<ProductNDC>43598-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin Inhalation Solution</ProprietaryName>
<NonProprietaryName>Tobramycin Inhalation Solution</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20190514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207080</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Tobramycin inhalation solution, USP is a tobramycin solution for inhalation. It is a sterile, clear, colorless to slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52 g/mol. Tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin USP is. Each single-dose 5 mL ampule contains 300 mg tobramycin, USP and 11.25 mg sodium chloride in sterile water for injection. Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0. Nitrogen is used for sparging. All ingredients meet USP requirements. The formulation contains no preservatives.</Description>
</NDC>
<NDC>
<NDCCode>50157-605-14</NDCCode>
<PackageDescription>1480 mL in 1 BOTTLE, PUMP (50157-605-14) </PackageDescription>
<NDC11Code>50157-0605-14</NDC11Code>
<ProductNDC>50157-605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial</ProprietaryName>
<ProprietaryNameSuffix>Spring Rain</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221114</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Brands International Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/1000mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use for handwashing to decrease bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62257-605-14</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (62257-605-14)</PackageDescription>
<NDC11Code>62257-0605-14</NDC11Code>
<ProductNDC>62257-605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcogel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070427</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>ABC Compounding Co., Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin, only when water is not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65841-605-14</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (65841-605-14) </PackageDescription>
<NDC11Code>65841-0605-14</NDC11Code>
<ProductNDC>65841-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079017</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-605-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-14) </PackageDescription>
<NDC11Code>71205-0605-14</NDC11Code>
<ProductNDC>71205-605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081297</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BENZONATATE is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>75990-605-14</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (75990-605-14) </PackageDescription>
<NDC11Code>75990-0605-14</NDC11Code>
<ProductNDC>75990-605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Recens</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110519</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Certus Medical, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83318-605-14</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (83318-605-14) </PackageDescription>
<NDC11Code>83318-0605-14</NDC11Code>
<ProductNDC>83318-605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Plus Brasept Alcocol Gel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230324</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>NEWDROP NORTH AMERICA LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin, only when water is not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84126-605-14</NDCCode>
<PackageDescription>147 mL in 1 TUBE (84126-605-14) </PackageDescription>
<NDC11Code>84126-0605-14</NDC11Code>
<ProductNDC>84126-605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Native Mineral Sunscreen Broad Spectrum Spf 30 Tropical Breeze</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-027-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-027-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0027-14</NDC11Code>
<ProductNDC>63776-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aller Balance</ProprietaryName>
<NonProprietaryName>Acetylcholine Chloride, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Epinephrine, Onion, Ammonium Carbonate, Apis Mellifera, Arsenic Trioxide, Histamine, Interferon Gamma-1a, Interleukin-12 Human, Manganese Gluconate, Luffa Operculata Fruit, Sus Scrofa Lung, Beef Lung, Sus Scrofa Nasal Mucosa, Bos Taurus Nasal Mucosa, Sodium Chloride, Bos Taurus Peyers Patch, Sus Scrofa Peyers Patch, Schoenocaulon Officinale Seed, Serotonin, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACETYLCHOLINE CHLORIDE; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; EPINEPHRINE; ONION; AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; MANGANESE GLUCONATE; LUFFA OPERCULATA FRUIT; SUS SCROFA LUNG; BEEF LUNG; SUS SCROFA NASAL MUCOSA; BOS TAURUS NASAL MUCOSA; SODIUM CHLORIDE; BOS TAURUS PEYER'S PATCH; SUS SCROFA PEYER'S PATCH; SCHOENOCAULON OFFICINALE SEED; SEROTONIN; BOS TAURUS THYMUS; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>200; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 4; 30; 200; 200; 200; 200; 200; 30; 30; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>63776-033-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-033-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0033-14</NDC11Code>
<ProductNDC>63776-033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ans/cns</ProprietaryName>
<NonProprietaryName>Acetylcholine Chloride, Epinephrine, .gamma.-aminobutyric Acid, Histamine, Goldenseal, Norepinephrine, Taraxacum Palustre Root, Tyramine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACETYLCHOLINE CHLORIDE; EPINEPHRINE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE; GOLDENSEAL; NOREPINEPHRINE; TARAXACUM PALUSTRE ROOT; TYRAMINE</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 3; 200; 30; 200</StrengthNumber>
<StrengthUnit>{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-035-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-035-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0035-14</NDC11Code>
<ProductNDC>63776-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>.ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; ASCORBIC ACID; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS CARTILAGE; BOS TAURUS JOINT CAPSULE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PLACENTA; BOS TAURUS RED BLOOD CELL; BOS TAURUS SOLAR PLEXUS; BOS TAURUS VEIN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CALCITONIN; COLCHICUM AUTUMNALE BULB; EDODEKIN ALFA; ERSOFERMIN; INTERFERON GAMMA-1A; METENKEFALIN; NADIDE; PORK COLLAGEN; PORK LIVER; QUINHYDRONE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA CARTILAGE; SUS SCROFA JOINT CAPSULE; SUS SCROFA LYMPH; SUS SCROFA MESENCHYME; SUS SCROFA PARATHYROID GLAND; SUS SCROFA RED BLOOD CELL; SUS SCROFA SOLAR PLEXUS; SUS SCROFA VEIN</SubstanceName>
<StrengthNumber>30; 30; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dopamine Agonists [MoA], Dopaminergic Agonist [EPC], Increased Histamine Release [PE], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of arthritic symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-037-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-037-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0037-14</NDC11Code>
<ProductNDC>63776-037</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Articula</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Bos Taurus Ankle Joint, Sus Scrofa Ankle Joint, Metenkefalin, Ersofermin, Bos Taurus Achilles Tendon, Sus Scrofa Achilles Tendon, Bos Taurus Hip Joint, Sus Scrofa Hip Joint, Bos Taurus Knee Joint, Sus Scrofa Knee Joint, Beef Liver, Pork Liver, Transforming Growth Factor Beta-1, Avotermin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; AVOTERMIN; BEEF LIVER; BOS TAURUS ACHILLES TENDON; BOS TAURUS ANKLE JOINT; BOS TAURUS HIP JOINT; BOS TAURUS KNEE JOINT; ERSOFERMIN; METENKEFALIN; PORK LIVER; SUS SCROFA ACHILLES TENDON; SUS SCROFA ANKLE JOINT; SUS SCROFA HIP JOINT; SUS SCROFA KNEE JOINT; TRANSFORMING GROWTH FACTOR BETA-1</SubstanceName>
<StrengthNumber>200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help support the repair & regeneration of articulations & joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-073-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-073-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0073-14</NDC11Code>
<ProductNDC>63776-073</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida</ProprietaryName>
<NonProprietaryName>Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Penicillin G Sodium, Vaccinium Vitis-idaea Leaf</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; YEAST MANNAN; PENICILLIN G SODIUM; VACCINIUM VITIS-IDAEA LEAF</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>63776-074-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-074-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0074-14</NDC11Code>
<ProductNDC>63776-074</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida Plus</ProprietaryName>
<NonProprietaryName>Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Vaccinium Vitis-idaea Leaf</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms due to Candida, including precursors and byproducts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-075-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-075-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0075-14</NDC11Code>
<ProductNDC>63776-075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida I</ProprietaryName>
<NonProprietaryName>Caffeic Acid, Candida Albicans, Tanacetum Parthenium, Centella Asiatica, Yeast Mannan, Penicillin G, Vaccinium Vitis-idaea Leaf Spray</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>CAFFEIC ACID; CANDIDA ALBICANS; TANACETUM PARTHENIUM; CENTELLA ASIATICA; YEAST MANNAN; PENICILLIN G; VACCINIUM VITIS-IDAEA LEAF</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-081-14</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63776-081-14) </PackageDescription>
<NDC11Code>63776-0081-14</NDC11Code>
<ProductNDC>63776-081</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-cellulite</ProprietaryName>
<NonProprietaryName>Androsterone, Artichoke, Atp, Bfgf, Camp, L-carnitine, Centella Asiatica, Citric Acid, Cobalt, Estrogen, Ferrum Fumaricum, Fumaric Acid, Ginkgo, Hamamelis, Hyaluronidase, Il-3, Kalium Asparticum, Lactic Acid, Lymphatic Vessel, Melilotus, Mn, Natrum Oxalaceticum, Natrum Pyruvicum, Quinhydrone, Succinic Acid, Vein, Vitamin A And Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; ADENOSINE TRIPHOSPHATE; ANDROSTERONE; ARTICHOKE; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BOS TAURUS LYMPH VESSEL; BOS TAURUS VEIN; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COBALT; ERSOFERMIN; ESTROGENS, ESTERIFIED; FERROUS FUMARATE; FUMARIC ACID; HAMAMELIS VIRGINIANA BARK; HEPTAMINOL; HYALURONIDASE; INTERLEUKIN-3; LACTIC ACID; LEVOCARNITINE; MANGANESE; MELILOTUS OFFICINALIS WHOLE; POTASSIUM ASPARTATE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA LYMPH VESSEL; SUS SCROFA VEIN; VITAMIN A; ZINC</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 200; 200; 200; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Allergens [CS], Allergens [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Carnitine Analog [EPC], Carnitine [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS], Vitamin A [CS], Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cellulite drainage & tonification, metabolism and lipid balance, hormonal support, circulatory support and regeneration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-095-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-095-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0095-14</NDC11Code>
<ProductNDC>63776-095</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Collagen</ProprietaryName>
<NonProprietaryName>Pork Collagen</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>PORK COLLAGEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[kp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help support collagen formation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-100-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-100-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0100-14</NDC11Code>
<ProductNDC>63776-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Connectissue</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Ascorbic Acid, Metenkefalin, Ersofermin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Interleukin-3, Interleukin-3, Beef Liver, Pork Liver, Beef, Pork, Bos Taurus Tendon, Sus Scrofa Tendon, Cetermin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ASCORBIC ACID; BEEF; BEEF LIVER; BOS TAURUS CARTILAGE; BOS TAURUS RED BLOOD CELL; BOS TAURUS TENDON; CETERMIN; ERSOFERMIN; INTERLEUKIN-3; METENKEFALIN; PORK; PORK COLLAGEN; PORK LIVER; SUS SCROFA CARTILAGE; SUS SCROFA RED BLOOD CELL; SUS SCROFA TENDON</SubstanceName>
<StrengthNumber>200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Meat Proteins [EXT], Meat Proteins [EXT], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help support the repair & regeneration of connective tissue & cartilage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-102-14</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63776-102-14) </PackageDescription>
<NDC11Code>63776-0102-14</NDC11Code>
<ProductNDC>63776-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-mesenchyme</ProprietaryName>
<NonProprietaryName>Adrenal, Ascorbic Acid, Bdnf, Dhea, Malic Acid, Bfgf, Fucus Vesiculosus, Histidine, Hyaluronidase, Il-6, Lactic Acid, Lymph Node, Mesenchyme, Nad, Natrum Oxalaceticum, Natrum Pyruvicum, Natrum Sulphuricum, Phenylalanine, Amino Acid, Pyrogenium, Thuja Occidentalis, Trichinoyl, Tyrosine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; FUCUS VESICULOSUS; HISTIDINE; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); HYALURONIDASE; LACTIC ACID; MALIC ACID; NADIDE; PHENYLALANINE; PRASTERONE; PROLACTIN; RANCID BEEF; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA MESENCHYME; THUJA OCCIDENTALIS LEAF; TYROSINE</SubstanceName>
<StrengthNumber>30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30; 200; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help encourage extra cellular / matrix / connective tissue drainage & support.</IndicationAndUsage>
<Description>Viatrexx-Mesenchyme is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-142-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-142-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0142-14</NDC11Code>
<ProductNDC>63776-142</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-enzyme Plus</ProprietaryName>
<NonProprietaryName>Amylase, Cellulase, Lactase, Lipase, Maltase, Protease, Sucrase</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>CELLULASE (TRICHODERMA LONGIBRACHIATUM); LACTASE; LYSOSOMAL ALPHA-GLUCOSIDASE; PANCREATIC ALPHA-AMYLASE; PANCREATIC TRIACYLGLYCEROL LIPASE; PANCRELIPASE PROTEASE; SACROSIDASE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Sucrose-specific Enzyme [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To support healthy digestion.</IndicationAndUsage>
<Description>Viatrexx-Enzyme + is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-165-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-165-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0165-14</NDC11Code>
<ProductNDC>63776-165</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foods</ProprietaryName>
<NonProprietaryName>Activated Charcoal, Ageratina Aromatica Root, Ferrous Iodide, Gelsemium Sempervirens Root, Calcium Sulfide, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Iodine, Potassium Gluconate, Lycopodium Clavatum Spore, Cajuput Oil, Black Currant, Rosa Canina Fruit, Serotonin, Xanthine, Almond, Apple, Banana, Barley, Bean, Beef, Cashew, Casein, Emmental Cultured, Casein, Lactococcus Lactis Cultured, Casein, Lactococcus Lactis Cultured Aged, Casein, Lactococcus Lactis Cultured</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; AGERATINA AROMATICA ROOT; ALMOND; APPLE; ARCHED SWIMMING CRAB, COOKED; BANANA; BARLEY; BEAN; BEEF; BLACK CURRANT; BLUE CRAB; BROWN RICE; CAJUPUT OIL; CALCIUM SULFIDE; CASEIN, EMMENTAL CULTURED; CASEIN, LACTOCOCCUS LACTIS CULTURED; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASHEW; CHICKEN; COCOA; COCONUT; COD, UNSPECIFIED; COFFEE BEAN; COTTON FIBER; COTTON SEED; COW MILK; DUNGENESS CRAB, COOKED; EGG; EGGPLANT; ENGLISH WALNUT; FERROUS IODIDE; FLAX SEED; GELSEMIUM SEMPERVIRENS ROOT; GREEN BELL PEPPER; HAZELNUT, UNSPECIFIED; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; IODINE; LAMB; LYCOPODIUM CLAVATUM SPORE; ONION; ORANGE; OYSTER, UNSPECIFIED; PEANUT; PECAN; PORK; POTASSIUM GLUCONATE; POTATO; ROSA CANINA FRUIT; SALMON, UNSPECIFIED; SEROTONIN; SERRATED SWIMMING CRAB, COOKED; SHRIMP, UNSPECIFIED; SNOW CRAB, UNSPECIFIED; SOYBEAN; STARCH, RICE; STRAWBERRY; TEA LEAF; TOMATO; TUNA, UNSPECIFIED; WHEAT; WHEAT GLUTEN; WHITE RICE; XANTHINE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 1; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 1; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Egg Proteins, Dietary [CS], Fish Proteins, Dietary [EXT], Fish Proteins, Dietary [EXT], Fish Proteins, Dietary [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help with sensitivities to common foods.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-170-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-170-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0170-14</NDC11Code>
<ProductNDC>63776-170</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Female</ProprietaryName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Cholesterol, Sus Scrofa Corpus Luteum, Esterified Estrogen, Bos Taurus Hypothalamus, Sus Scrofa Hypothalamus, Melatonin, Bos Taurus Ovary, Sus Scrofa Ovary, Bos Taurus Pancreas, Sus Scrofa Pancreas, Bos Taurus Pineal Gland, Sus Scrofa Pineal Gland, Bos Taurus Pituitary Gland, Sus Scrofa Pituitary Gland, Progesterone, Sus Scrofa Thalamus, Bos Taurus Thymus, Sus Scrofa Thymus, Thyroid Bovine, Thyroid Porcine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; CHOLESTEROL; SUS SCROFA CORPUS LUTEUM; ESTROGENS, ESTERIFIED; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; MELATONIN; BOS TAURUS OVARY; SUS SCROFA OVARY; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS PINEAL GLAND; SUS SCROFA PINEAL GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; PROGESTERONE; SUS SCROFA THALAMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-175-14</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63776-175-14) </PackageDescription>
<NDC11Code>63776-0175-14</NDC11Code>
<ProductNDC>63776-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-f Gus</ProprietaryName>
<NonProprietaryName>Berberis, Cochlerearia Armor, Echinacea, Ferrum, Hydrastis, Iridium, Lapacho, Lomatium, Lycopodium, Myrrh, Phosporicum Acidum, Propolis, Pulsatilla, Seleneium, Thymus, Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANEMONE PULSATILLA; ARMORACIA RUSTICANA WHOLE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS THYMUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HANDROANTHUS IMPETIGINOSUS WHOLE; IRIDIUM; IRON; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHOSPHORIC ACID; PROPOLIS WAX; SELENIUM; SUS SCROFA THYMUS; ZINC</SubstanceName>
<StrengthNumber>12; 3; 3; 6; 3; 3; 3; 12; 12; 3; 12; 3; 12; 3; 12; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>nutritional support for fungal, mold, bacteria challenges.</IndicationAndUsage>
<Description>Viatrexx-F gus is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
</NDCList>