{
"NDC": [
{
"NDCCode": "63776-440-14",
"PackageDescription": "30 mL in 1 BOTTLE (63776-440-14) ",
"NDC11Code": "63776-0440-14",
"ProductNDC": "63776-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pollens Early",
"NonProprietaryName": "Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN",
"StrengthNumber": "200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200",
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"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], Bee Venoms [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], Dietary Proteins [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180301",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary support of symptoms related to seasonal spring sensitivities."
},
{
"NDCCode": "33342-440-14",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (33342-440-14) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02) ",
"NDC11Code": "33342-0440-14",
"ProductNDC": "33342-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abacavir And Lamivudine",
"NonProprietaryName": "Abacavir And Lamivudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212663",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ABACAVIR SULFATE; LAMIVUDINE",
"StrengthNumber": "600; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "Abacavir and lamivudine tablets, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.",
"Description": "Abacavir and lamivudine tablets ,USP Abacavir and lamivudine tablets,USP contain the following 2 synthetic nucleoside analogues: abacavir (ZIAGEN, also a component of TRIZIVIR) and lamivudine (also known as EPIVIR or 3TC) with inhibitory activity against HIV-1. Abacavir and lamivudine tablets, USP are for oral administration. Each orange, film-coated tablet contains the active ingredients 600 mg of abacavir as abacavir sulfate USP and 300 mg of Lamivudine USP, and the inactive ingredients magnesium stearate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, low-substituted hydroxypropyl cellulose and povidone. The tablets are coated with a film (Instacoat Universal Orange A05G32713) that is made of FD&C Yellow No. 6, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide. Abacavir Sulfate The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2H2SO4 and a molecular weight of 670.76 g per mol. It has the following structural formula: Abacavir sulfate is a white to off-white solid and is soluble in water. In vivo, abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir.Lamivudine The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-) 2′, 3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula: Lamivudine is a white to off-white crystalline solid and is soluble in water."
},
{
"NDCCode": "41520-440-14",
"PackageDescription": "1 BOTTLE in 1 BOX (41520-440-14) > 144 TABLET, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "41520-0440-14",
"ProductNDC": "41520-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"ProprietaryNameSuffix": "Enteric Safety Coated",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100715",
"EndMarketingDate": "20200101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Care One (American Sales Company)",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100715",
"EndMarketingDatePackage": "20200101",
"SamplePackage": "N"
},
{
"NDCCode": "46581-440-04",
"PackageDescription": "14.6 g in 1 CAN (46581-440-04) ",
"NDC11Code": "46581-0440-04",
"ProductNDC": "46581-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salonpas Pain Relieving Jet",
"NonProprietaryName": "Menthol, Methyl Salicylate",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "PERCUTANEOUS; TOPICAL; TRANSDERMAL",
"StartMarketingDate": "20110501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Hisamitsu Pharmaceutical Co., Inc.",
"SubstanceName": "MENTHOL; METHYL SALICYLATE",
"StrengthNumber": "3; 10",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110501",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of minor aches and pains of muscles and joints associated with: 1 strains, 2 sprains, 3 bruises, 4 simple backache, 5 arthritis."
},
{
"NDCCode": "49035-440-14",
"PackageDescription": "420 mL in 1 BOTTLE, PLASTIC (49035-440-14)",
"NDC11Code": "49035-0440-14",
"ProductNDC": "49035-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Beauty Color Safe Dandruff Conditioner",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161215",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Wal-Mart Store Inc",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "to help prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "61919-440-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (61919-440-14) ",
"NDC11Code": "61919-0440-14",
"ProductNDC": "61919-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076890",
"LabelerName": "DIRECT RX",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180315",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. 1.1 Nosocomial Pneumonia. Levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen. Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae[see Dosage and Administration (2.1) and Clinical Studies (14.2)]. MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥ 2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen. Levofloxacin is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae[see Dosage and Administration (2.1) and Clinical Studies (14.3)]. 1.4 Complicated Skin and Skin Structure Infections. Levofloxacin is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)]. 1.5 Uncomplicated Skin and Skin Structure Infections. Levofloxacin is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Chronic Bacterial Prostatitis. Levofloxacin is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)]. 1.7 Inhalational Anthrax (Post-Exposure). Levofloxacin is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)]. 1.8 Plague. Levofloxacin is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of levofloxacin could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Dosage and Administration (2.1,2.2) and Clinical Studies (14.10)]. 1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen. Levofloxacin is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)]. 1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen. Levofloxacin is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)]. 1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen. Levofloxacin is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)]. 1.12 Uncomplicated Urinary Tract Infections. Levofloxacin is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.15)] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. 1.13 Acute Bacterial Exacerbation of Chronic Bronchitis. Levofloxacin is indicated for the treatment of acute bacterial exacerbation (ABS) of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1to 5.15)] and for some patients ABECB is self-limiting, reserve levofloxacin for treatment of ABECB in patients who have no alternative treatment options. 1.14 Acute Bacterial Sinusitis: 5-day and 10 to 14 day Treatment Regimens. Levofloxacin is indicated for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)]. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1to 5.15)] and for some patients ABS is self-limiting, reserve levofloxacin for treatment of ABS in patients who have no alternative treatment options. 1.15 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
"Description": "[levofloxacinfigure1]. Levofloxacin, USP is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin, USP The molecular formula is C18H20FN3O4 1/2 H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish-white to yellow-white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage Form Levofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg: croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. 500 mg: croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. 750 mg: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Levofloxacin tablets, USP meets USP Dissolution Test 2."
},
{
"NDCCode": "63776-440-11",
"PackageDescription": ".5 mL in 1 AMPULE (63776-440-11) ",
"NDC11Code": "63776-0440-11",
"ProductNDC": "63776-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pollens Early",
"NonProprietaryName": "Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN",
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"NDC11Code": "63776-0440-19",
"ProductNDC": "63776-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pollens Early",
"NonProprietaryName": "Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN",
"StrengthNumber": "200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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",
"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], Bee Venoms [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], Dietary Proteins [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210325",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary support of symptoms related to seasonal spring sensitivities."
},
{
"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",
"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",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"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",
"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",
"NDC11Code": "63776-0170-14",
"ProductNDC": "63776-170",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Female",
"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",
"DosageFormName": "SPRAY",
"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."
},
{
"NDCCode": "63776-176-14",
"PackageDescription": "30 mL in 1 BOTTLE (63776-176-14) ",
"NDC11Code": "63776-0176-14",
"ProductNDC": "63776-176",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Female Plus",
"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",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20190201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; BOS TAURUS OVARY; BOS TAURUS PANCREAS; BOS TAURUS PINEAL GLAND; BOS TAURUS PITUITARY GLAND; BOS TAURUS THYMUS; CHOLESTEROL; ESTROGENS, ESTERIFIED; MELATONIN; PROGESTERONE; SUS SCROFA ADRENAL GLAND; SUS SCROFA CORPUS LUTEUM; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THALAMUS; 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",
"Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190201",
"SamplePackage": "N",
"IndicationAndUsage": "To help support the structure & function of the female endocrine system."
},
{
"NDCCode": "63776-189-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-189-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0189-14",
"ProductNDC": "63776-189",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-gi",
"NonProprietaryName": "Anti-interleukin 1, Ankle Articulations, Beta Endorphin, Bfgf, Calcaneal Tendon, Hip Articulation, Knee Articulation, Liver, Transforming Growth Factor-1, Transforming Gf-beta",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
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"ProductNdcExcludeFlag": "N",
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},
{
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20190705",
"SamplePackage": "N",
"IndicationAndUsage": "May help encourage heavy metal drainage.",
"Description": "Viatrexx-H Metals 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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<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
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<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
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<PackageDescription>5 BLISTER PACK in 1 CARTON (33342-440-14) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02) </PackageDescription>
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<StartMarketingDate>20241220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212663</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ABACAVIR SULFATE; LAMIVUDINE</SubstanceName>
<StrengthNumber>600; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Abacavir and lamivudine tablets, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.</IndicationAndUsage>
<Description>Abacavir and lamivudine tablets ,USP Abacavir and lamivudine tablets,USP contain the following 2 synthetic nucleoside analogues: abacavir (ZIAGEN, also a component of TRIZIVIR) and lamivudine (also known as EPIVIR or 3TC) with inhibitory activity against HIV-1. Abacavir and lamivudine tablets, USP are for oral administration. Each orange, film-coated tablet contains the active ingredients 600 mg of abacavir as abacavir sulfate USP and 300 mg of Lamivudine USP, and the inactive ingredients magnesium stearate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, low-substituted hydroxypropyl cellulose and povidone. The tablets are coated with a film (Instacoat Universal Orange A05G32713) that is made of FD&C Yellow No. 6, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide. Abacavir Sulfate The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2H2SO4 and a molecular weight of 670.76 g per mol. It has the following structural formula: Abacavir sulfate is a white to off-white solid and is soluble in water. In vivo, abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir.Lamivudine The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-) 2′, 3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula: Lamivudine is a white to off-white crystalline solid and is soluble in water.</Description>
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<ProprietaryName>Aspirin</ProprietaryName>
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<IndicationAndUsage>For temporary relief of minor aches and pains of muscles and joints associated with: 1 strains, 2 sprains, 3 bruises, 4 simple backache, 5 arthritis.</IndicationAndUsage>
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<IndicationAndUsage>to help prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
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<PackageDescription>14 TABLET in 1 BOTTLE (61919-440-14) </PackageDescription>
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<ProprietaryName>Levofloxacin</ProprietaryName>
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<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
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<IndicationAndUsage>Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. 1.1 Nosocomial Pneumonia. Levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen. Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae[see Dosage and Administration (2.1) and Clinical Studies (14.2)]. MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥ 2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen. Levofloxacin is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae[see Dosage and Administration (2.1) and Clinical Studies (14.3)]. 1.4 Complicated Skin and Skin Structure Infections. Levofloxacin is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)]. 1.5 Uncomplicated Skin and Skin Structure Infections. Levofloxacin is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Chronic Bacterial Prostatitis. Levofloxacin is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)]. 1.7 Inhalational Anthrax (Post-Exposure). Levofloxacin is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)]. 1.8 Plague. Levofloxacin is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of levofloxacin could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Dosage and Administration (2.1,2.2) and Clinical Studies (14.10)]. 1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen. Levofloxacin is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)]. 1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen. Levofloxacin is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)]. 1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen. Levofloxacin is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)]. 1.12 Uncomplicated Urinary Tract Infections. Levofloxacin is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.15)] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. 1.13 Acute Bacterial Exacerbation of Chronic Bronchitis. Levofloxacin is indicated for the treatment of acute bacterial exacerbation (ABS) of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1to 5.15)] and for some patients ABECB is self-limiting, reserve levofloxacin for treatment of ABECB in patients who have no alternative treatment options. 1.14 Acute Bacterial Sinusitis: 5-day and 10 to 14 day Treatment Regimens. Levofloxacin is indicated for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)]. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1to 5.15)] and for some patients ABS is self-limiting, reserve levofloxacin for treatment of ABS in patients who have no alternative treatment options. 1.15 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.</IndicationAndUsage>
<Description>[levofloxacinfigure1]. Levofloxacin, USP is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin, USP The molecular formula is C18H20FN3O4 1/2 H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish-white to yellow-white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage Form Levofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg: croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. 500 mg: croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. 750 mg: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Levofloxacin tablets, USP meets USP Dissolution Test 2.</Description>
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<PackageDescription>.5 mL in 1 AMPULE (63776-440-11) </PackageDescription>
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<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
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<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], Bee Venoms [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], Dietary Proteins [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
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<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
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<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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</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], Bee Venoms [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], Dietary Proteins [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-440-16</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (63776-440-16) </PackageDescription>
<NDC11Code>63776-0440-16</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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</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], Bee Venoms [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], Dietary Proteins [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-440-17</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (63776-440-17) </PackageDescription>
<NDC11Code>63776-0440-17</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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</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], Bee Venoms [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], Dietary Proteins [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-440-18</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (63776-440-18) </PackageDescription>
<NDC11Code>63776-0440-18</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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</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], Bee Venoms [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], Dietary Proteins [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-440-19</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (63776-440-19) </PackageDescription>
<NDC11Code>63776-0440-19</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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</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], Bee Venoms [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], Dietary Proteins [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</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>
<NDC>
<NDCCode>63776-176-14</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63776-176-14) </PackageDescription>
<NDC11Code>63776-0176-14</NDC11Code>
<ProductNDC>63776-176</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Female Plus</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>20190201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; BOS TAURUS OVARY; BOS TAURUS PANCREAS; BOS TAURUS PINEAL GLAND; BOS TAURUS PITUITARY GLAND; BOS TAURUS THYMUS; CHOLESTEROL; ESTROGENS, ESTERIFIED; MELATONIN; PROGESTERONE; SUS SCROFA ADRENAL GLAND; SUS SCROFA CORPUS LUTEUM; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THALAMUS; 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>
<Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help support the structure & function of the female endocrine system.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-189-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-189-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0189-14</NDC11Code>
<ProductNDC>63776-189</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-gi</ProprietaryName>
<NonProprietaryName>Anti-interleukin 1, Ankle Articulations, Beta Endorphin, Bfgf, Calcaneal Tendon, Hip Articulation, Knee Articulation, Liver, Transforming Growth Factor-1, Transforming Gf-beta</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ALOE; ALUMINUM OXIDE; BOS TAURUS COLON; BOS TAURUS PEYER'S PATCH; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; FRANGULA ALNUS BARK; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; MILK THISTLE; NIACIN; PANTOTHENIC ACID; POTASSIUM CARBONATE; SEROTONIN; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA COLON; SUS SCROFA PEYER'S PATCH; SUS SCROFA RECTUM; TARAXACUM OFFICINALE; THIAMINE; VITAMIN D</SubstanceName>
<StrengthNumber>30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 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; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [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], Increased Histamine Release [PE], Increased IgG Production [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</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 GI tract/ Bowel function and elimination.</IndicationAndUsage>
<Description>Viatrexx-GI is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-205-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-205-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0205-14</NDC11Code>
<ProductNDC>63776-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-h Metals</ProprietaryName>
<NonProprietaryName>Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; CYSTEINE; FORMALDEHYDE; GARLIC; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; METHIONINE; PHENOL; PHYTOLACCA AMERICANA ROOT; RED CLOVER; SELENIUM; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>3; 12; 3; 3; 6; 12; 3; 6; 12; 3; 12; 3; 3; 6; 12; 3; 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>
<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], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Vitamin C [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>May help encourage heavy metal drainage.</IndicationAndUsage>
<Description>Viatrexx-H Metals 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>
<NDCList><NDC><NDCCode>63776-440-14</NDCCode><ProprietaryName>Pollens Early</ProprietaryName><NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName></NDC><NDC><NDCCode>33342-440-14</NDCCode><ProprietaryName>Abacavir And Lamivudine</ProprietaryName><NonProprietaryName>Abacavir And Lamivudine</NonProprietaryName></NDC><NDC><NDCCode>41520-440-14</NDCCode><ProprietaryName>Aspirin</ProprietaryName><NonProprietaryName>Aspirin</NonProprietaryName></NDC><NDC><NDCCode>46581-440-04</NDCCode><ProprietaryName>Salonpas Pain Relieving Jet</ProprietaryName><NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName></NDC><NDC><NDCCode>49035-440-14</NDCCode><ProprietaryName>Equate Beauty Color Safe Dandruff Conditioner</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>61919-440-14</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>63776-440-11</NDCCode><ProprietaryName>Pollens Early</ProprietaryName><NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName></NDC><NDC><NDCCode>63776-440-15</NDCCode><ProprietaryName>Pollens Early</ProprietaryName><NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName></NDC><NDC><NDCCode>63776-440-16</NDCCode><ProprietaryName>Pollens Early</ProprietaryName><NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName></NDC><NDC><NDCCode>63776-440-17</NDCCode><ProprietaryName>Pollens Early</ProprietaryName><NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName></NDC><NDC><NDCCode>63776-440-18</NDCCode><ProprietaryName>Pollens Early</ProprietaryName><NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName></NDC><NDC><NDCCode>63776-440-19</NDCCode><ProprietaryName>Pollens Early</ProprietaryName><NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName></NDC><NDC><NDCCode>63776-027-14</NDCCode><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></NDC><NDC><NDCCode>63776-033-14</NDCCode><ProprietaryName>Ans/cns</ProprietaryName><NonProprietaryName>Acetylcholine Chloride, Epinephrine, .gamma.-aminobutyric Acid, Histamine, Goldenseal, Norepinephrine, Taraxacum Palustre Root, Tyramine</NonProprietaryName></NDC><NDC><NDCCode>63776-035-14</NDCCode><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></NDC><NDC><NDCCode>63776-037-14</NDCCode><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></NDC><NDC><NDCCode>63776-073-14</NDCCode><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></NDC><NDC><NDCCode>63776-074-14</NDCCode><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></NDC><NDC><NDCCode>63776-075-14</NDCCode><ProprietaryName>Candida I</ProprietaryName><NonProprietaryName>Caffeic Acid, Candida Albicans, Tanacetum Parthenium, Centella Asiatica, Yeast Mannan, Penicillin G, Vaccinium Vitis-idaea Leaf Spray</NonProprietaryName></NDC><NDC><NDCCode>63776-081-14</NDCCode><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></NDC><NDC><NDCCode>63776-095-14</NDCCode><ProprietaryName>Collagen</ProprietaryName><NonProprietaryName>Pork Collagen</NonProprietaryName></NDC><NDC><NDCCode>63776-100-14</NDCCode><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></NDC><NDC><NDCCode>63776-102-14</NDCCode><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></NDC><NDC><NDCCode>63776-142-14</NDCCode><ProprietaryName>Viatrexx-enzyme Plus</ProprietaryName><NonProprietaryName>Amylase, Cellulase, Lactase, Lipase, Maltase, Protease, Sucrase</NonProprietaryName></NDC><NDC><NDCCode>63776-165-14</NDCCode><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></NDC><NDC><NDCCode>63776-170-14</NDCCode><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></NDC><NDC><NDCCode>63776-175-14</NDCCode><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></NDC><NDC><NDCCode>63776-176-14</NDCCode><ProprietaryName>Female Plus</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></NDC><NDC><NDCCode>63776-189-14</NDCCode><ProprietaryName>Viatrexx-gi</ProprietaryName><NonProprietaryName>Anti-interleukin 1, Ankle Articulations, Beta Endorphin, Bfgf, Calcaneal Tendon, Hip Articulation, Knee Articulation, Liver, Transforming Growth Factor-1, Transforming Gf-beta</NonProprietaryName></NDC><NDC><NDCCode>63776-205-14</NDCCode><ProprietaryName>Viatrexx-h Metals</ProprietaryName><NonProprietaryName>Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium</NonProprietaryName></NDC></NDCList>