{
"NDC": [
{
"NDCCode": "62670-4572-3",
"PackageDescription": "431 g in 1 BOTTLE, PUMP (62670-4572-3)",
"NDC11Code": "62670-4572-03",
"ProductNDC": "62670-4572",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Kitchen Lemon",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130611",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-09-05"
},
{
"NDCCode": "50090-4572-0",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE (50090-4572-0) ",
"NDC11Code": "50090-4572-00",
"ProductNDC": "50090-4572",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200839",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190930",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) Chronic bacterial prostatitis (1.6) Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) Plague in adult and pediatric patients (1.8) Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) Acute Pyelonephritis (1.11) Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) Acute Bacterial Sinusitis (1.14). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).",
"Description": "Levofloxacin USP are synthetic antibacterial agents 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. The empirical formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal 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 . Levofloxacin USP is available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide., 2 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides., 3 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80."
},
{
"NDCCode": "50090-4572-1",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (50090-4572-1) ",
"NDC11Code": "50090-4572-01",
"ProductNDC": "50090-4572",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200839",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190930",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) Chronic bacterial prostatitis (1.6) Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) Plague in adult and pediatric patients (1.8) Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) Acute Pyelonephritis (1.11) Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) Acute Bacterial Sinusitis (1.14). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).",
"Description": "Levofloxacin USP are synthetic antibacterial agents 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. The empirical formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal 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 . Levofloxacin USP is available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide., 2 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides., 3 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80."
},
{
"NDCCode": "50090-4572-4",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (50090-4572-4) ",
"NDC11Code": "50090-4572-04",
"ProductNDC": "50090-4572",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200839",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190930",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) Chronic bacterial prostatitis (1.6) Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) Plague in adult and pediatric patients (1.8) Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) Acute Pyelonephritis (1.11) Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) Acute Bacterial Sinusitis (1.14). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).",
"Description": "Levofloxacin USP are synthetic antibacterial agents 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. The empirical formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal 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 . Levofloxacin USP is available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide., 2 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides., 3 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80."
},
{
"NDCCode": "54868-4572-0",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-4572-0)",
"NDC11Code": "54868-4572-00",
"ProductNDC": "54868-4572",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kadian",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20011107",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020616",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "KADIAN® Capsules are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (see CLINICAL PHARMACOLOGY). KADIAN® Capsules are NOT intended for use as a prn analgesic. KADIAN® is not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild or not expected to persist for an extended period of time. KADIAN® is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).",
"Description": "KADIAN® (morphine sulfate) capsules are an opioid analgesic supplied in 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, and 200 mg strengths for oral administration. Chemically, morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste and a molecular weight of 758 (as the sulfate). It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Each KADIAN® extended-release capsule contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, or 200 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and black ink, D&C red #28, FD&C blue #1 (10 mg), D&C yellow #10 (20 mg), FD&C red #3, FD&C blue #1 (30 mg), D&C red #28, FD&C red #40, FD&C blue #1 (50 mg), D&C red #28, FD&C red #40, FD&C blue #1 (60 mg), FD&C blue #1, FD&C red #40, FD&C yellow #6 (80 mg), D&C yellow #10, FD&C blue #1 (100 mg), black iron oxide, yellow iron oxide, red iron oxide (200 mg)."
},
{
"NDCCode": "54868-4572-1",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-4572-1)",
"NDC11Code": "54868-4572-01",
"ProductNDC": "54868-4572",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kadian",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20011107",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020616",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "KADIAN® Capsules are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (see CLINICAL PHARMACOLOGY). KADIAN® Capsules are NOT intended for use as a prn analgesic. KADIAN® is not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild or not expected to persist for an extended period of time. KADIAN® is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).",
"Description": "KADIAN® (morphine sulfate) capsules are an opioid analgesic supplied in 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, and 200 mg strengths for oral administration. Chemically, morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste and a molecular weight of 758 (as the sulfate). It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Each KADIAN® extended-release capsule contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, or 200 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and black ink, D&C red #28, FD&C blue #1 (10 mg), D&C yellow #10 (20 mg), FD&C red #3, FD&C blue #1 (30 mg), D&C red #28, FD&C red #40, FD&C blue #1 (50 mg), D&C red #28, FD&C red #40, FD&C blue #1 (60 mg), FD&C blue #1, FD&C red #40, FD&C yellow #6 (80 mg), D&C yellow #10, FD&C blue #1 (100 mg), black iron oxide, yellow iron oxide, red iron oxide (200 mg)."
},
{
"NDCCode": "54868-4572-2",
"PackageDescription": "20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-4572-2)",
"NDC11Code": "54868-4572-02",
"ProductNDC": "54868-4572",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kadian",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20011107",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020616",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "KADIAN® Capsules are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (see CLINICAL PHARMACOLOGY). KADIAN® Capsules are NOT intended for use as a prn analgesic. KADIAN® is not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild or not expected to persist for an extended period of time. KADIAN® is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).",
"Description": "KADIAN® (morphine sulfate) capsules are an opioid analgesic supplied in 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, and 200 mg strengths for oral administration. Chemically, morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste and a molecular weight of 758 (as the sulfate). It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Each KADIAN® extended-release capsule contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, or 200 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and black ink, D&C red #28, FD&C blue #1 (10 mg), D&C yellow #10 (20 mg), FD&C red #3, FD&C blue #1 (30 mg), D&C red #28, FD&C red #40, FD&C blue #1 (50 mg), D&C red #28, FD&C red #40, FD&C blue #1 (60 mg), FD&C blue #1, FD&C red #40, FD&C yellow #6 (80 mg), D&C yellow #10, FD&C blue #1 (100 mg), black iron oxide, yellow iron oxide, red iron oxide (200 mg)."
},
{
"NDCCode": "55714-4572-0",
"PackageDescription": "15 mL in 1 BOTTLE, GLASS (55714-4572-0)",
"NDC11Code": "55714-4572-00",
"ProductNDC": "55714-4572",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dairy - Grain - Nightshades",
"NonProprietaryName": "Cow Milk, Skim Milk, Cow Milk Fat, Casein Lactococcus Lactis Cultured Aged, Casein Lactococcus Lactis Cultured Penicilium Roqueforti Cultured Aged, Casein Lctococcus Lactis Cultured Penicillium Camemberti Cultured Aged, Barley, Corn, Wheat Gluten, Oat, White Rice, Rye, Wheat, Lycopersicum Esculentum, Sac. Lac., Solanum Tuberosum,torula Cerevisiae, Ustilago Maidis, Antimon. Crud., Arg.nit., Arsenicum Alb., Baptisia, Bryonia, Carduus Benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "COW MILK; SKIM MILK; COW MILK FAT; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; BARLEY; CORN; WHEAT GLUTEN; OAT; WHITE RICE; RYE; WHEAT; ATROPA BELLADONNA; CAPSICUM; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; SOLANUM NIGRUM WHOLE; DATURA STRAMONIUM; TOBACCO LEAF; SOLANUM LYCOPERSICUM; LACTOSE; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; ELYMUS REPENS ROOT; VERBASCUM THAPSUS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE",
"StrengthNumber": "60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10",
"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; [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; [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",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Milk Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Vegetable Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Formulated for symptoms associated with respiratory, gastro-intestinal, integumentary or vascular systems."
},
{
"NDCCode": "55714-4572-1",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (55714-4572-1)",
"NDC11Code": "55714-4572-01",
"ProductNDC": "55714-4572",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dairy - Grain - Nightshades",
"NonProprietaryName": "Cow Milk, Skim Milk, Cow Milk Fat, Casein Lactococcus Lactis Cultured Aged, Casein Lactococcus Lactis Cultured Penicilium Roqueforti Cultured Aged, Casein Lctococcus Lactis Cultured Penicillium Camemberti Cultured Aged, Barley, Corn, Wheat Gluten, Oat, White Rice, Rye, Wheat, Lycopersicum Esculentum, Sac. Lac., Solanum Tuberosum,torula Cerevisiae, Ustilago Maidis, Antimon. Crud., Arg.nit., Arsenicum Alb., Baptisia, Bryonia, Carduus Benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "COW MILK; SKIM MILK; COW MILK FAT; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; BARLEY; CORN; WHEAT GLUTEN; OAT; WHITE RICE; RYE; WHEAT; ATROPA BELLADONNA; CAPSICUM; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; SOLANUM NIGRUM WHOLE; DATURA STRAMONIUM; TOBACCO LEAF; SOLANUM LYCOPERSICUM; LACTOSE; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; ELYMUS REPENS ROOT; VERBASCUM THAPSUS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE",
"StrengthNumber": "60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10",
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"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Milk Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Vegetable Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Formulated for symptoms associated with respiratory, gastro-intestinal, integumentary or vascular systems."
},
{
"NDCCode": "55714-4572-2",
"PackageDescription": "59 mL in 1 BOTTLE, GLASS (55714-4572-2)",
"NDC11Code": "55714-4572-02",
"ProductNDC": "55714-4572",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dairy - Grain - Nightshades",
"NonProprietaryName": "Cow Milk, Skim Milk, Cow Milk Fat, Casein Lactococcus Lactis Cultured Aged, Casein Lactococcus Lactis Cultured Penicilium Roqueforti Cultured Aged, Casein Lctococcus Lactis Cultured Penicillium Camemberti Cultured Aged, Barley, Corn, Wheat Gluten, Oat, White Rice, Rye, Wheat, Lycopersicum Esculentum, Sac. Lac., Solanum Tuberosum,torula Cerevisiae, Ustilago Maidis, Antimon. Crud., Arg.nit., Arsenicum Alb., Baptisia, Bryonia, Carduus Benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "COW MILK; SKIM MILK; COW MILK FAT; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; BARLEY; CORN; WHEAT GLUTEN; OAT; WHITE RICE; RYE; WHEAT; ATROPA BELLADONNA; CAPSICUM; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; SOLANUM NIGRUM WHOLE; DATURA STRAMONIUM; TOBACCO LEAF; SOLANUM LYCOPERSICUM; LACTOSE; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; ELYMUS REPENS ROOT; VERBASCUM THAPSUS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE",
"StrengthNumber": "60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10",
"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; [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; [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",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Milk Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Vegetable Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Formulated for symptoms associated with respiratory, gastro-intestinal, integumentary or vascular systems."
},
{
"NDCCode": "62670-3564-3",
"PackageDescription": "236 mL in 1 BOTTLE, PUMP (62670-3564-3)",
"NDC11Code": "62670-3564-03",
"ProductNDC": "62670-3564",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Deep Cleansing Hand",
"ProprietaryNameSuffix": "Cherry Blossom",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"EndMarketingDate": "20140731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".3",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2014-08-08"
},
{
"NDCCode": "62670-3565-3",
"PackageDescription": "236 mL in 1 BOTTLE, PUMP (62670-3565-3)",
"NDC11Code": "62670-3565-03",
"ProductNDC": "62670-3565",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Deep Cleansing Hand",
"ProprietaryNameSuffix": "Coconut Lime Verbena",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".3",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2014-05-14"
},
{
"NDCCode": "62670-3566-3",
"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3566-3)",
"NDC11Code": "62670-3566-03",
"ProductNDC": "62670-3566",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Deep Cleansing Hand Soap",
"ProprietaryNameSuffix": "Cucumber Melon",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "62670-3568-3",
"PackageDescription": "259 mL in 1 BOTTLE, PUMP (62670-3568-3)",
"NDC11Code": "62670-3568-03",
"ProductNDC": "62670-3568",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Gentle Foaming Hand",
"ProprietaryNameSuffix": "Black Raspberry Vanilla",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"EndMarketingDate": "20140731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".3",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2014-08-08"
},
{
"NDCCode": "62670-3570-3",
"PackageDescription": "236 g in 1 BOTTLE, PUMP (62670-3570-3)",
"NDC11Code": "62670-3570-03",
"ProductNDC": "62670-3570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Moisturizing Hand Soap",
"ProprietaryNameSuffix": "Black Raspberry Vanilla",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "62670-3574-3",
"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3574-3)",
"NDC11Code": "62670-3574-03",
"ProductNDC": "62670-3574",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Deep Cleansing Hand Soap",
"ProprietaryNameSuffix": "Frosted Orange Spice",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "62670-3575-3",
"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3575-3)",
"NDC11Code": "62670-3575-03",
"ProductNDC": "62670-3575",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Deep Cleansing Hand Soap",
"ProprietaryNameSuffix": "Fresh Market Apple",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "62670-3576-3",
"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3576-3)",
"NDC11Code": "62670-3576-03",
"ProductNDC": "62670-3576",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Deep Cleansing Hand Soap",
"ProprietaryNameSuffix": "Japanese Cherry Blossom",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "62670-3577-3",
"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3577-3)",
"NDC11Code": "62670-3577-03",
"ProductNDC": "62670-3577",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Deep Cleansing Hand Soap",
"ProprietaryNameSuffix": "Kitchen Lemon",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "62670-3578-3",
"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3578-3)",
"NDC11Code": "62670-3578-03",
"ProductNDC": "62670-3578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Deep Cleansing Hand Soap",
"ProprietaryNameSuffix": "Moonligh Path",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "62670-3579-3",
"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3579-3)",
"NDC11Code": "62670-3579-03",
"ProductNDC": "62670-3579",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Deep Cleansing Hand Soap",
"ProprietaryNameSuffix": "Nectarine Mint",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
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},
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"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3582-3)",
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"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "Bath & Body Works, Inc.",
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},
{
"NDCCode": "62670-3583-3",
"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3583-3)",
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"ProductTypeName": "HUMAN OTC DRUG",
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"ProprietaryNameSuffix": "Sweet Pea",
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"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
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"StrengthUnit": "mg/g",
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},
{
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"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3584-3)",
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},
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"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3585-3)",
"NDC11Code": "62670-3585-03",
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"LabelerName": "Bath & Body Works, Inc.",
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"StrengthUnit": "mg/g",
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},
{
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"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3586-3)",
"NDC11Code": "62670-3586-03",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Deep Cleansing Hand Soap",
"ProprietaryNameSuffix": "Wild Honeysuckle",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-05-19"
},
{
"NDCCode": "62670-3587-3",
"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3587-3)",
"NDC11Code": "62670-3587-03",
"ProductNDC": "62670-3587",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Deep Cleansing Hand Soap",
"ProprietaryNameSuffix": "Island Nectar",
"NonProprietaryName": "Triclosan",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "62670-3588-3",
"PackageDescription": "263 g in 1 BOTTLE, PUMP (62670-3588-3)",
"NDC11Code": "62670-3588-03",
"ProductNDC": "62670-3588",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Gentle Foaming Hand Soap",
"ProprietaryNameSuffix": "Cherry Blossom",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-04-22"
}
]
}
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<PackageDescription>431 g in 1 BOTTLE, PUMP (62670-4572-3)</PackageDescription>
<NDC11Code>62670-4572-03</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Kitchen Lemon</ProprietaryNameSuffix>
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<LastUpdate>2014-09-05</LastUpdate>
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<PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE (50090-4572-0) </PackageDescription>
<NDC11Code>50090-4572-00</NDC11Code>
<ProductNDC>50090-4572</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200839</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) Chronic bacterial prostatitis (1.6) Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) Plague in adult and pediatric patients (1.8) Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) Acute Pyelonephritis (1.11) Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) Acute Bacterial Sinusitis (1.14). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).</IndicationAndUsage>
<Description>Levofloxacin USP are synthetic antibacterial agents 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. The empirical formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal 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 . Levofloxacin USP is available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide., 2 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides., 3 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80.</Description>
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<NDCCode>50090-4572-1</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (50090-4572-1) </PackageDescription>
<NDC11Code>50090-4572-01</NDC11Code>
<ProductNDC>50090-4572</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200839</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Levofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) Chronic bacterial prostatitis (1.6) Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) Plague in adult and pediatric patients (1.8) Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) Acute Pyelonephritis (1.11) Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) Acute Bacterial Sinusitis (1.14). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).</IndicationAndUsage>
<Description>Levofloxacin USP are synthetic antibacterial agents 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. The empirical formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal 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 . Levofloxacin USP is available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide., 2 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides., 3 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>50090-4572-4</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (50090-4572-4) </PackageDescription>
<NDC11Code>50090-4572-04</NDC11Code>
<ProductNDC>50090-4572</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
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<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) Chronic bacterial prostatitis (1.6) Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) Plague in adult and pediatric patients (1.8) Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) Acute Pyelonephritis (1.11) Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) Acute Bacterial Sinusitis (1.14). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).</IndicationAndUsage>
<Description>Levofloxacin USP are synthetic antibacterial agents 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. The empirical formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin USP is a light yellowish-white to yellow-white crystal 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 . Levofloxacin USP is available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red iron oxide., 2 500 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80 and synthetic red and yellow iron oxides., 3 750 mg (as expressed in the anhydrous form): hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>54868-4572-0</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-4572-0)</PackageDescription>
<NDC11Code>54868-4572-00</NDC11Code>
<ProductNDC>54868-4572</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kadian</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011107</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020616</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>KADIAN® Capsules are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (see CLINICAL PHARMACOLOGY). KADIAN® Capsules are NOT intended for use as a prn analgesic. KADIAN® is not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild or not expected to persist for an extended period of time. KADIAN® is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).</IndicationAndUsage>
<Description>KADIAN® (morphine sulfate) capsules are an opioid analgesic supplied in 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, and 200 mg strengths for oral administration. Chemically, morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste and a molecular weight of 758 (as the sulfate). It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Each KADIAN® extended-release capsule contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, or 200 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and black ink, D&C red #28, FD&C blue #1 (10 mg), D&C yellow #10 (20 mg), FD&C red #3, FD&C blue #1 (30 mg), D&C red #28, FD&C red #40, FD&C blue #1 (50 mg), D&C red #28, FD&C red #40, FD&C blue #1 (60 mg), FD&C blue #1, FD&C red #40, FD&C yellow #6 (80 mg), D&C yellow #10, FD&C blue #1 (100 mg), black iron oxide, yellow iron oxide, red iron oxide (200 mg).</Description>
</NDC>
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<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-4572-1)</PackageDescription>
<NDC11Code>54868-4572-01</NDC11Code>
<ProductNDC>54868-4572</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kadian</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011107</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020616</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>KADIAN® Capsules are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (see CLINICAL PHARMACOLOGY). KADIAN® Capsules are NOT intended for use as a prn analgesic. KADIAN® is not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild or not expected to persist for an extended period of time. KADIAN® is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).</IndicationAndUsage>
<Description>KADIAN® (morphine sulfate) capsules are an opioid analgesic supplied in 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, and 200 mg strengths for oral administration. Chemically, morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste and a molecular weight of 758 (as the sulfate). It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Each KADIAN® extended-release capsule contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, or 200 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and black ink, D&C red #28, FD&C blue #1 (10 mg), D&C yellow #10 (20 mg), FD&C red #3, FD&C blue #1 (30 mg), D&C red #28, FD&C red #40, FD&C blue #1 (50 mg), D&C red #28, FD&C red #40, FD&C blue #1 (60 mg), FD&C blue #1, FD&C red #40, FD&C yellow #6 (80 mg), D&C yellow #10, FD&C blue #1 (100 mg), black iron oxide, yellow iron oxide, red iron oxide (200 mg).</Description>
</NDC>
<NDC>
<NDCCode>54868-4572-2</NDCCode>
<PackageDescription>20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-4572-2)</PackageDescription>
<NDC11Code>54868-4572-02</NDC11Code>
<ProductNDC>54868-4572</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kadian</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011107</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020616</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>KADIAN® Capsules are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (see CLINICAL PHARMACOLOGY). KADIAN® Capsules are NOT intended for use as a prn analgesic. KADIAN® is not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild or not expected to persist for an extended period of time. KADIAN® is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.).</IndicationAndUsage>
<Description>KADIAN® (morphine sulfate) capsules are an opioid analgesic supplied in 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, and 200 mg strengths for oral administration. Chemically, morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste and a molecular weight of 758 (as the sulfate). It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Each KADIAN® extended-release capsule contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, or 200 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and black ink, D&C red #28, FD&C blue #1 (10 mg), D&C yellow #10 (20 mg), FD&C red #3, FD&C blue #1 (30 mg), D&C red #28, FD&C red #40, FD&C blue #1 (50 mg), D&C red #28, FD&C red #40, FD&C blue #1 (60 mg), FD&C blue #1, FD&C red #40, FD&C yellow #6 (80 mg), D&C yellow #10, FD&C blue #1 (100 mg), black iron oxide, yellow iron oxide, red iron oxide (200 mg).</Description>
</NDC>
<NDC>
<NDCCode>55714-4572-0</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, GLASS (55714-4572-0)</PackageDescription>
<NDC11Code>55714-4572-00</NDC11Code>
<ProductNDC>55714-4572</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dairy - Grain - Nightshades</ProprietaryName>
<NonProprietaryName>Cow Milk, Skim Milk, Cow Milk Fat, Casein Lactococcus Lactis Cultured Aged, Casein Lactococcus Lactis Cultured Penicilium Roqueforti Cultured Aged, Casein Lctococcus Lactis Cultured Penicillium Camemberti Cultured Aged, Barley, Corn, Wheat Gluten, Oat, White Rice, Rye, Wheat, Lycopersicum Esculentum, Sac. Lac., Solanum Tuberosum,torula Cerevisiae, Ustilago Maidis, Antimon. Crud., Arg.nit., Arsenicum Alb., Baptisia, Bryonia, Carduus Benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>COW MILK; SKIM MILK; COW MILK FAT; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; BARLEY; CORN; WHEAT GLUTEN; OAT; WHITE RICE; RYE; WHEAT; ATROPA BELLADONNA; CAPSICUM; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; SOLANUM NIGRUM WHOLE; DATURA STRAMONIUM; TOBACCO LEAF; SOLANUM LYCOPERSICUM; LACTOSE; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; ELYMUS REPENS ROOT; VERBASCUM THAPSUS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE</SubstanceName>
<StrengthNumber>60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10</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; [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; [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>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Milk Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Vegetable Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Formulated for symptoms associated with respiratory, gastro-intestinal, integumentary or vascular systems.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-4572-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (55714-4572-1)</PackageDescription>
<NDC11Code>55714-4572-01</NDC11Code>
<ProductNDC>55714-4572</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dairy - Grain - Nightshades</ProprietaryName>
<NonProprietaryName>Cow Milk, Skim Milk, Cow Milk Fat, Casein Lactococcus Lactis Cultured Aged, Casein Lactococcus Lactis Cultured Penicilium Roqueforti Cultured Aged, Casein Lctococcus Lactis Cultured Penicillium Camemberti Cultured Aged, Barley, Corn, Wheat Gluten, Oat, White Rice, Rye, Wheat, Lycopersicum Esculentum, Sac. Lac., Solanum Tuberosum,torula Cerevisiae, Ustilago Maidis, Antimon. Crud., Arg.nit., Arsenicum Alb., Baptisia, Bryonia, Carduus Benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>COW MILK; SKIM MILK; COW MILK FAT; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; BARLEY; CORN; WHEAT GLUTEN; OAT; WHITE RICE; RYE; WHEAT; ATROPA BELLADONNA; CAPSICUM; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; SOLANUM NIGRUM WHOLE; DATURA STRAMONIUM; TOBACCO LEAF; SOLANUM LYCOPERSICUM; LACTOSE; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; ELYMUS REPENS ROOT; VERBASCUM THAPSUS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE</SubstanceName>
<StrengthNumber>60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10</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; [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; [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>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Milk Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Vegetable Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Formulated for symptoms associated with respiratory, gastro-intestinal, integumentary or vascular systems.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-4572-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, GLASS (55714-4572-2)</PackageDescription>
<NDC11Code>55714-4572-02</NDC11Code>
<ProductNDC>55714-4572</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dairy - Grain - Nightshades</ProprietaryName>
<NonProprietaryName>Cow Milk, Skim Milk, Cow Milk Fat, Casein Lactococcus Lactis Cultured Aged, Casein Lactococcus Lactis Cultured Penicilium Roqueforti Cultured Aged, Casein Lctococcus Lactis Cultured Penicillium Camemberti Cultured Aged, Barley, Corn, Wheat Gluten, Oat, White Rice, Rye, Wheat, Lycopersicum Esculentum, Sac. Lac., Solanum Tuberosum,torula Cerevisiae, Ustilago Maidis, Antimon. Crud., Arg.nit., Arsenicum Alb., Baptisia, Bryonia, Carduus Benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>COW MILK; SKIM MILK; COW MILK FAT; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; BARLEY; CORN; WHEAT GLUTEN; OAT; WHITE RICE; RYE; WHEAT; ATROPA BELLADONNA; CAPSICUM; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; SOLANUM NIGRUM WHOLE; DATURA STRAMONIUM; TOBACCO LEAF; SOLANUM LYCOPERSICUM; LACTOSE; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; ELYMUS REPENS ROOT; VERBASCUM THAPSUS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE</SubstanceName>
<StrengthNumber>60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10</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; [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; [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>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Milk Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Vegetable Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Formulated for symptoms associated with respiratory, gastro-intestinal, integumentary or vascular systems.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62670-3564-3</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PUMP (62670-3564-3)</PackageDescription>
<NDC11Code>62670-3564-03</NDC11Code>
<ProductNDC>62670-3564</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand</ProprietaryName>
<ProprietaryNameSuffix>Cherry Blossom</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<EndMarketingDate>20140731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3565-3</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PUMP (62670-3565-3)</PackageDescription>
<NDC11Code>62670-3565-03</NDC11Code>
<ProductNDC>62670-3565</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand</ProprietaryName>
<ProprietaryNameSuffix>Coconut Lime Verbena</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-05-14</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3566-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3566-3)</PackageDescription>
<NDC11Code>62670-3566-03</NDC11Code>
<ProductNDC>62670-3566</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Cucumber Melon</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3568-3</NDCCode>
<PackageDescription>259 mL in 1 BOTTLE, PUMP (62670-3568-3)</PackageDescription>
<NDC11Code>62670-3568-03</NDC11Code>
<ProductNDC>62670-3568</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Gentle Foaming Hand</ProprietaryName>
<ProprietaryNameSuffix>Black Raspberry Vanilla</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<EndMarketingDate>20140731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3570-3</NDCCode>
<PackageDescription>236 g in 1 BOTTLE, PUMP (62670-3570-3)</PackageDescription>
<NDC11Code>62670-3570-03</NDC11Code>
<ProductNDC>62670-3570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Moisturizing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Black Raspberry Vanilla</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3574-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3574-3)</PackageDescription>
<NDC11Code>62670-3574-03</NDC11Code>
<ProductNDC>62670-3574</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Frosted Orange Spice</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3575-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3575-3)</PackageDescription>
<NDC11Code>62670-3575-03</NDC11Code>
<ProductNDC>62670-3575</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Fresh Market Apple</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3576-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3576-3)</PackageDescription>
<NDC11Code>62670-3576-03</NDC11Code>
<ProductNDC>62670-3576</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Japanese Cherry Blossom</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3577-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3577-3)</PackageDescription>
<NDC11Code>62670-3577-03</NDC11Code>
<ProductNDC>62670-3577</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Kitchen Lemon</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3578-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3578-3)</PackageDescription>
<NDC11Code>62670-3578-03</NDC11Code>
<ProductNDC>62670-3578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Moonligh Path</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3579-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3579-3)</PackageDescription>
<NDC11Code>62670-3579-03</NDC11Code>
<ProductNDC>62670-3579</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Nectarine Mint</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3580-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3580-3)</PackageDescription>
<NDC11Code>62670-3580-03</NDC11Code>
<ProductNDC>62670-3580</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Pink Grapefruit</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3581-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3581-3)</PackageDescription>
<NDC11Code>62670-3581-03</NDC11Code>
<ProductNDC>62670-3581</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Rainkissed Leaves</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3582-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3582-3)</PackageDescription>
<NDC11Code>62670-3582-03</NDC11Code>
<ProductNDC>62670-3582</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Sea Island Cotton</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3583-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3583-3)</PackageDescription>
<NDC11Code>62670-3583-03</NDC11Code>
<ProductNDC>62670-3583</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Sweet Pea</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-05-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3584-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3584-3)</PackageDescription>
<NDC11Code>62670-3584-03</NDC11Code>
<ProductNDC>62670-3584</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Warm Vanilla Sugar</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-05-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3585-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3585-3)</PackageDescription>
<NDC11Code>62670-3585-03</NDC11Code>
<ProductNDC>62670-3585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>White Citrus</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-05-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3586-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3586-3)</PackageDescription>
<NDC11Code>62670-3586-03</NDC11Code>
<ProductNDC>62670-3586</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Wild Honeysuckle</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-05-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3587-3</NDCCode>
<PackageDescription>242 g in 1 BOTTLE, PUMP (62670-3587-3)</PackageDescription>
<NDC11Code>62670-3587-03</NDC11Code>
<ProductNDC>62670-3587</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Deep Cleansing Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Island Nectar</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-3588-3</NDCCode>
<PackageDescription>263 g in 1 BOTTLE, PUMP (62670-3588-3)</PackageDescription>
<NDC11Code>62670-3588-03</NDC11Code>
<ProductNDC>62670-3588</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Gentle Foaming Hand Soap</ProprietaryName>
<ProprietaryNameSuffix>Cherry Blossom</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-04-22</LastUpdate>
</NDC>
</NDCList>