{
"NDC": [
{
"NDCCode": "62670-4568-3",
"PackageDescription": "431 g in 1 BOTTLE, PUMP (62670-4568-3)",
"NDC11Code": "62670-4568-03",
"ProductNDC": "62670-4568",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Citrus Garland",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130603",
"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": "54868-4568-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (54868-4568-3)",
"NDC11Code": "54868-4568-03",
"ProductNDC": "54868-4568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074253",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge”, irritability, impatience.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white, crystalline, water soluble compound with a molecular weight of 422.0. Chemically buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8-azaspiro[4,5]decane-7,9- dione monohydrochloride. The molecular formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "68071-4568-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68071-4568-3) ",
"NDC11Code": "68071-4568-03",
"ProductNDC": "68071-4568",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hcl",
"NonProprietaryName": "Fexofenadine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204507",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180920",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat."
},
{
"NDCCode": "50090-4568-0",
"PackageDescription": "29 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-4568-0) ",
"NDC11Code": "50090-4568-00",
"ProductNDC": "50090-4568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200834",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190927",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: : 1 Major Depressive Disorder (MDD), 2 Social Anxiety Disorder (SAD) , 3 Generalized Anxiety Disorder (GAD), 4 Panic Disorder (PD).",
"Description": "Venlafaxine hydrochloride extended-release capsule USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride USP, a SNRI. Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride USP is a white or almost white crystalline powder, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, hypromellose, sugar spheres, and talc. The empty hard gelatin capsule shells contain iron oxide red, gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 37.5 mg empty hard gelatin capsule shells contain iron oxide black. The capsules are printed with edible ink containing black iron oxide and shellac. Meets the USP Dissolution Test - 4."
},
{
"NDCCode": "54868-4568-0",
"PackageDescription": "60 TABLET in 1 BOTTLE (54868-4568-0)",
"NDC11Code": "54868-4568-00",
"ProductNDC": "54868-4568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074253",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge”, irritability, impatience.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white, crystalline, water soluble compound with a molecular weight of 422.0. Chemically buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8-azaspiro[4,5]decane-7,9- dione monohydrochloride. The molecular formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "54868-4568-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (54868-4568-1)",
"NDC11Code": "54868-4568-01",
"ProductNDC": "54868-4568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074253",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge”, irritability, impatience.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white, crystalline, water soluble compound with a molecular weight of 422.0. Chemically buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8-azaspiro[4,5]decane-7,9- dione monohydrochloride. The molecular formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "54868-4568-5",
"PackageDescription": "120 TABLET in 1 BOTTLE (54868-4568-5)",
"NDC11Code": "54868-4568-05",
"ProductNDC": "54868-4568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074253",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge”, irritability, impatience.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white, crystalline, water soluble compound with a molecular weight of 422.0. Chemically buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8-azaspiro[4,5]decane-7,9- dione monohydrochloride. The molecular formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "55714-4568-0",
"PackageDescription": "15 mL in 1 BOTTLE, GLASS (55714-4568-0)",
"NDC11Code": "55714-4568-00",
"ProductNDC": "55714-4568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Food Allergy - Additive",
"NonProprietaryName": "E102 Tartrazine, E104 Quinoline Yellow, E110 Sunset/orange Yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal Red A, E127 Erythrosine, D128 Red 2g, E 132 Indigotine, E141 Copper/chlorophyll Complex, E142 Green S, E211 Sodium Benzoate, E212 Potassium Benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium Metabisulphate, E231 Orthophenylphenol, E250 Sodium Nitrate, E300 Ascorbic Acid, E399 Sodium Mono/bi/triphosphate, E951 Aspartame, Monosodium Glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "EGG; FD&C YELLOW NO. 5; D&C YELLOW NO. 10; FD&C YELLOW NO. 6; CARMOISINE; AMARANTH; PONCEAU 4R; FD&C RED NO. 3; ACID RED 1; FD&C BLUE NO. 2; SODIUM COPPER CHLOROPHYLLIN; ACID GREEN 50; SODIUM BENZOATE; POTASSIUM BENZOATE; PROPYLPARABEN; SODIUM DITHIONATE; 2-PHENYLPHENOL; SODIUM NITRITE; ASCORBIC ACID; SODIUM TRIPOLYPHOSPHATE; ASPARTAME; MONOSODIUM GLUTAMATE; BEEF; PORK; LAMB; CHICKEN; TURKEY; QUAHOG, UNSPECIFIED; CRAB LEG, UNSPECIFIED; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; SCALLOP, UNSPECIFIED; AMANITA MUSCARIA FRUITING BODY; ONION; GARLIC; ANACARDIUM OCCIDENTALE FRUIT; LYCOPERDON UTRIFORME FRUITING BODY; CAFFEINE; CAPSICUM; CINNAMON; CYNARA SCOLYMUS LEAF; ALPINE STRAWBERRY; ABRUS PRECATORIUS SEED; GLYCYRRHIZA GLABRA; MENTHA PIPERITA; NUTMEG; LACTOSE; SUCROSE; BLACK MUSTARD SEED; SOLANUM NIGRUM WHOLE; ALLYLTHIOUREA; USTILAGO MAYDIS; GINGER; BRAZIL NUT; HAZELNUT, UNSPECIFIED; PEANUT; TROUT, UNSPECIFIED; COD, UNSPECIFIED; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; SOLANUM LYCOPERSICUM; SACCHARIN; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; URTICA URENS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP",
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"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; [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",
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"Status": "Deprecated",
"LastUpdate": "2019-12-06",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-4568-1",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (55714-4568-1)",
"NDC11Code": "55714-4568-01",
"ProductNDC": "55714-4568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Food Allergy - Additive",
"NonProprietaryName": "E102 Tartrazine, E104 Quinoline Yellow, E110 Sunset/orange Yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal Red A, E127 Erythrosine, D128 Red 2g, E 132 Indigotine, E141 Copper/chlorophyll Complex, E142 Green S, E211 Sodium Benzoate, E212 Potassium Benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium Metabisulphate, E231 Orthophenylphenol, E250 Sodium Nitrate, E300 Ascorbic Acid, E399 Sodium Mono/bi/triphosphate, E951 Aspartame, Monosodium Glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "EGG; FD&C YELLOW NO. 5; D&C YELLOW NO. 10; FD&C YELLOW NO. 6; CARMOISINE; AMARANTH; PONCEAU 4R; FD&C RED NO. 3; ACID RED 1; FD&C BLUE NO. 2; SODIUM COPPER CHLOROPHYLLIN; ACID GREEN 50; SODIUM BENZOATE; POTASSIUM BENZOATE; PROPYLPARABEN; SODIUM DITHIONATE; 2-PHENYLPHENOL; SODIUM NITRITE; ASCORBIC ACID; SODIUM TRIPOLYPHOSPHATE; ASPARTAME; MONOSODIUM GLUTAMATE; BEEF; PORK; LAMB; CHICKEN; TURKEY; QUAHOG, UNSPECIFIED; CRAB LEG, UNSPECIFIED; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; SCALLOP, UNSPECIFIED; AMANITA MUSCARIA FRUITING BODY; ONION; GARLIC; ANACARDIUM OCCIDENTALE FRUIT; LYCOPERDON UTRIFORME FRUITING BODY; CAFFEINE; CAPSICUM; CINNAMON; CYNARA SCOLYMUS LEAF; ALPINE STRAWBERRY; ABRUS PRECATORIUS SEED; GLYCYRRHIZA GLABRA; MENTHA PIPERITA; NUTMEG; LACTOSE; SUCROSE; BLACK MUSTARD SEED; SOLANUM NIGRUM WHOLE; ALLYLTHIOUREA; USTILAGO MAYDIS; GINGER; BRAZIL NUT; HAZELNUT, UNSPECIFIED; PEANUT; TROUT, UNSPECIFIED; COD, UNSPECIFIED; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; SOLANUM LYCOPERSICUM; SACCHARIN; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; URTICA URENS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP",
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"Status": "Deprecated",
"LastUpdate": "2019-12-06",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-4568-2",
"PackageDescription": "59 mL in 1 BOTTLE, GLASS (55714-4568-2)",
"NDC11Code": "55714-4568-02",
"ProductNDC": "55714-4568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Food Allergy - Additive",
"NonProprietaryName": "E102 Tartrazine, E104 Quinoline Yellow, E110 Sunset/orange Yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal Red A, E127 Erythrosine, D128 Red 2g, E 132 Indigotine, E141 Copper/chlorophyll Complex, E142 Green S, E211 Sodium Benzoate, E212 Potassium Benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium Metabisulphate, E231 Orthophenylphenol, E250 Sodium Nitrate, E300 Ascorbic Acid, E399 Sodium Mono/bi/triphosphate, E951 Aspartame, Monosodium Glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "EGG; FD&C YELLOW NO. 5; D&C YELLOW NO. 10; FD&C YELLOW NO. 6; CARMOISINE; AMARANTH; PONCEAU 4R; FD&C RED NO. 3; ACID RED 1; FD&C BLUE NO. 2; SODIUM COPPER CHLOROPHYLLIN; ACID GREEN 50; SODIUM BENZOATE; POTASSIUM BENZOATE; PROPYLPARABEN; SODIUM DITHIONATE; 2-PHENYLPHENOL; SODIUM NITRITE; ASCORBIC ACID; SODIUM TRIPOLYPHOSPHATE; ASPARTAME; MONOSODIUM GLUTAMATE; BEEF; PORK; LAMB; CHICKEN; TURKEY; QUAHOG, UNSPECIFIED; CRAB LEG, UNSPECIFIED; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; SCALLOP, UNSPECIFIED; AMANITA MUSCARIA FRUITING BODY; ONION; GARLIC; ANACARDIUM OCCIDENTALE FRUIT; LYCOPERDON UTRIFORME FRUITING BODY; CAFFEINE; CAPSICUM; CINNAMON; CYNARA SCOLYMUS LEAF; ALPINE STRAWBERRY; ABRUS PRECATORIUS SEED; GLYCYRRHIZA GLABRA; MENTHA PIPERITA; NUTMEG; LACTOSE; SUCROSE; BLACK MUSTARD SEED; SOLANUM NIGRUM WHOLE; ALLYLTHIOUREA; USTILAGO MAYDIS; GINGER; BRAZIL NUT; HAZELNUT, UNSPECIFIED; PEANUT; TROUT, UNSPECIFIED; COD, UNSPECIFIED; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; SOLANUM LYCOPERSICUM; SACCHARIN; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; URTICA URENS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP",
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"Status": "Deprecated",
"LastUpdate": "2019-12-06",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
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},
{
"NDCCode": "62670-3565-3",
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"SubstanceName": "TRICLOSAN",
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},
{
"NDCCode": "62670-3566-3",
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},
{
"NDCCode": "62670-3568-3",
"PackageDescription": "259 mL in 1 BOTTLE, PUMP (62670-3568-3)",
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"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".3",
"StrengthUnit": "g/100mL",
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},
{
"NDCCode": "62670-3570-3",
"PackageDescription": "236 g in 1 BOTTLE, PUMP (62670-3570-3)",
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},
{
"NDCCode": "62670-3574-3",
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"StrengthUnit": "mg/g",
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},
{
"NDCCode": "62670-3575-3",
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"StrengthUnit": "mg/g",
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},
{
"NDCCode": "62670-3576-3",
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"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
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},
{
"NDCCode": "62670-3577-3",
"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3577-3)",
"NDC11Code": "62670-3577-03",
"ProductNDC": "62670-3577",
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"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
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"StrengthUnit": "mg/g",
"Status": "Deprecated",
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},
{
"NDCCode": "62670-3578-3",
"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3578-3)",
"NDC11Code": "62670-3578-03",
"ProductNDC": "62670-3578",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
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"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "62670-3579-3",
"PackageDescription": "242 g in 1 BOTTLE, PUMP (62670-3579-3)",
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"StrengthUnit": "mg/g",
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},
{
"NDCCode": "62670-3580-3",
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"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
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"StrengthUnit": "mg/g",
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"LastUpdate": "2014-03-05"
},
{
"NDCCode": "62670-3581-3",
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"StrengthUnit": "mg/g",
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},
{
"NDCCode": "62670-3582-3",
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"LabelerName": "Bath & Body Works, Inc.",
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"StrengthUnit": "mg/g",
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"LastUpdate": "2014-03-05"
},
{
"NDCCode": "62670-3583-3",
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},
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"NDCCode": "62670-3584-3",
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"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
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"LastUpdate": "2014-05-12"
},
{
"NDCCode": "62670-3585-3",
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},
{
"NDCCode": "62670-3586-3",
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"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-05-19"
},
{
"NDCCode": "62670-3587-3",
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"StrengthUnit": "mg/g",
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"LastUpdate": "2014-03-05"
},
{
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"StrengthNumber": "3",
"StrengthUnit": "mg/g",
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"LastUpdate": "2014-04-22"
}
]
}
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<NDCList>
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<PackageDescription>431 g in 1 BOTTLE, PUMP (62670-4568-3)</PackageDescription>
<NDC11Code>62670-4568-03</NDC11Code>
<ProductNDC>62670-4568</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Citrus Garland</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130603</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-09-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>54868-4568-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (54868-4568-3)</PackageDescription>
<NDC11Code>54868-4568-03</NDC11Code>
<ProductNDC>54868-4568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074253</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge”, irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white, crystalline, water soluble compound with a molecular weight of 422.0. Chemically buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8-azaspiro[4,5]decane-7,9- dione monohydrochloride. The molecular formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>68071-4568-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68071-4568-3) </PackageDescription>
<NDC11Code>68071-4568-03</NDC11Code>
<ProductNDC>68071-4568</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hcl</ProprietaryName>
<NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204507</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-4568-0</NDCCode>
<PackageDescription>29 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-4568-0) </PackageDescription>
<NDC11Code>50090-4568-00</NDC11Code>
<ProductNDC>50090-4568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200834</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: : 1 Major Depressive Disorder (MDD), 2 Social Anxiety Disorder (SAD) , 3 Generalized Anxiety Disorder (GAD), 4 Panic Disorder (PD).</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsule USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride USP, a SNRI. Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride USP is a white or almost white crystalline powder, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, hypromellose, sugar spheres, and talc. The empty hard gelatin capsule shells contain iron oxide red, gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 37.5 mg empty hard gelatin capsule shells contain iron oxide black. The capsules are printed with edible ink containing black iron oxide and shellac. Meets the USP Dissolution Test - 4.</Description>
</NDC>
<NDC>
<NDCCode>54868-4568-0</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (54868-4568-0)</PackageDescription>
<NDC11Code>54868-4568-00</NDC11Code>
<ProductNDC>54868-4568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074253</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge”, irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white, crystalline, water soluble compound with a molecular weight of 422.0. Chemically buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8-azaspiro[4,5]decane-7,9- dione monohydrochloride. The molecular formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>54868-4568-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (54868-4568-1)</PackageDescription>
<NDC11Code>54868-4568-01</NDC11Code>
<ProductNDC>54868-4568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074253</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge”, irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white, crystalline, water soluble compound with a molecular weight of 422.0. Chemically buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8-azaspiro[4,5]decane-7,9- dione monohydrochloride. The molecular formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>54868-4568-5</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (54868-4568-5)</PackageDescription>
<NDC11Code>54868-4568-05</NDC11Code>
<ProductNDC>54868-4568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074253</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge”, irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white, crystalline, water soluble compound with a molecular weight of 422.0. Chemically buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8-azaspiro[4,5]decane-7,9- dione monohydrochloride. The molecular formula C21H31N5O2 HCl is represented by the following structural formula. Each tablet for oral administration contains 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>55714-4568-0</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, GLASS (55714-4568-0)</PackageDescription>
<NDC11Code>55714-4568-00</NDC11Code>
<ProductNDC>55714-4568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Food Allergy - Additive</ProprietaryName>
<NonProprietaryName>E102 Tartrazine, E104 Quinoline Yellow, E110 Sunset/orange Yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal Red A, E127 Erythrosine, D128 Red 2g, E 132 Indigotine, E141 Copper/chlorophyll Complex, E142 Green S, E211 Sodium Benzoate, E212 Potassium Benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium Metabisulphate, E231 Orthophenylphenol, E250 Sodium Nitrate, E300 Ascorbic Acid, E399 Sodium Mono/bi/triphosphate, E951 Aspartame, Monosodium Glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>EGG; FD&C YELLOW NO. 5; D&C YELLOW NO. 10; FD&C YELLOW NO. 6; CARMOISINE; AMARANTH; PONCEAU 4R; FD&C RED NO. 3; ACID RED 1; FD&C BLUE NO. 2; SODIUM COPPER CHLOROPHYLLIN; ACID GREEN 50; SODIUM BENZOATE; POTASSIUM BENZOATE; PROPYLPARABEN; SODIUM DITHIONATE; 2-PHENYLPHENOL; SODIUM NITRITE; ASCORBIC ACID; SODIUM TRIPOLYPHOSPHATE; ASPARTAME; MONOSODIUM GLUTAMATE; BEEF; PORK; LAMB; CHICKEN; TURKEY; QUAHOG, UNSPECIFIED; CRAB LEG, UNSPECIFIED; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; SCALLOP, UNSPECIFIED; AMANITA MUSCARIA FRUITING BODY; ONION; GARLIC; ANACARDIUM OCCIDENTALE FRUIT; LYCOPERDON UTRIFORME FRUITING BODY; CAFFEINE; CAPSICUM; CINNAMON; CYNARA SCOLYMUS LEAF; ALPINE STRAWBERRY; ABRUS PRECATORIUS SEED; GLYCYRRHIZA GLABRA; MENTHA PIPERITA; NUTMEG; LACTOSE; SUCROSE; BLACK MUSTARD SEED; SOLANUM NIGRUM WHOLE; ALLYLTHIOUREA; USTILAGO MAYDIS; GINGER; BRAZIL NUT; HAZELNUT, UNSPECIFIED; PEANUT; TROUT, UNSPECIFIED; COD, UNSPECIFIED; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; SOLANUM LYCOPERSICUM; SACCHARIN; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; URTICA URENS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 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; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 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</StrengthNumber>
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<Pharm_Classes>Egg Proteins, Dietary [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Poultry Proteins [EXT],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Poultry Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],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 Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Food Additives [CS],Allergens [CS],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Plant Proteins [CS],Dietary Proteins [CS],Food Additives [CS],Seed Storage Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],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 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],Food Additives [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-06</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-4568-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (55714-4568-1)</PackageDescription>
<NDC11Code>55714-4568-01</NDC11Code>
<ProductNDC>55714-4568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Food Allergy - Additive</ProprietaryName>
<NonProprietaryName>E102 Tartrazine, E104 Quinoline Yellow, E110 Sunset/orange Yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal Red A, E127 Erythrosine, D128 Red 2g, E 132 Indigotine, E141 Copper/chlorophyll Complex, E142 Green S, E211 Sodium Benzoate, E212 Potassium Benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium Metabisulphate, E231 Orthophenylphenol, E250 Sodium Nitrate, E300 Ascorbic Acid, E399 Sodium Mono/bi/triphosphate, E951 Aspartame, Monosodium Glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>EGG; FD&C YELLOW NO. 5; D&C YELLOW NO. 10; FD&C YELLOW NO. 6; CARMOISINE; AMARANTH; PONCEAU 4R; FD&C RED NO. 3; ACID RED 1; FD&C BLUE NO. 2; SODIUM COPPER CHLOROPHYLLIN; ACID GREEN 50; SODIUM BENZOATE; POTASSIUM BENZOATE; PROPYLPARABEN; SODIUM DITHIONATE; 2-PHENYLPHENOL; SODIUM NITRITE; ASCORBIC ACID; SODIUM TRIPOLYPHOSPHATE; ASPARTAME; MONOSODIUM GLUTAMATE; BEEF; PORK; LAMB; CHICKEN; TURKEY; QUAHOG, UNSPECIFIED; CRAB LEG, UNSPECIFIED; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; SCALLOP, UNSPECIFIED; AMANITA MUSCARIA FRUITING BODY; ONION; GARLIC; ANACARDIUM OCCIDENTALE FRUIT; LYCOPERDON UTRIFORME FRUITING BODY; CAFFEINE; CAPSICUM; CINNAMON; CYNARA SCOLYMUS LEAF; ALPINE STRAWBERRY; ABRUS PRECATORIUS SEED; GLYCYRRHIZA GLABRA; MENTHA PIPERITA; NUTMEG; LACTOSE; SUCROSE; BLACK MUSTARD SEED; SOLANUM NIGRUM WHOLE; ALLYLTHIOUREA; USTILAGO MAYDIS; GINGER; BRAZIL NUT; HAZELNUT, UNSPECIFIED; PEANUT; TROUT, UNSPECIFIED; COD, UNSPECIFIED; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; SOLANUM LYCOPERSICUM; SACCHARIN; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; URTICA URENS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 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; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 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</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; [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>Egg Proteins, Dietary [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Poultry Proteins [EXT],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Poultry Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],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 Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Food Additives [CS],Allergens [CS],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Plant Proteins [CS],Dietary Proteins [CS],Food Additives [CS],Seed Storage Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],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 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],Food Additives [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-06</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-4568-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, GLASS (55714-4568-2)</PackageDescription>
<NDC11Code>55714-4568-02</NDC11Code>
<ProductNDC>55714-4568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Food Allergy - Additive</ProprietaryName>
<NonProprietaryName>E102 Tartrazine, E104 Quinoline Yellow, E110 Sunset/orange Yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal Red A, E127 Erythrosine, D128 Red 2g, E 132 Indigotine, E141 Copper/chlorophyll Complex, E142 Green S, E211 Sodium Benzoate, E212 Potassium Benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium Metabisulphate, E231 Orthophenylphenol, E250 Sodium Nitrate, E300 Ascorbic Acid, E399 Sodium Mono/bi/triphosphate, E951 Aspartame, Monosodium Glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>EGG; FD&C YELLOW NO. 5; D&C YELLOW NO. 10; FD&C YELLOW NO. 6; CARMOISINE; AMARANTH; PONCEAU 4R; FD&C RED NO. 3; ACID RED 1; FD&C BLUE NO. 2; SODIUM COPPER CHLOROPHYLLIN; ACID GREEN 50; SODIUM BENZOATE; POTASSIUM BENZOATE; PROPYLPARABEN; SODIUM DITHIONATE; 2-PHENYLPHENOL; SODIUM NITRITE; ASCORBIC ACID; SODIUM TRIPOLYPHOSPHATE; ASPARTAME; MONOSODIUM GLUTAMATE; BEEF; PORK; LAMB; CHICKEN; TURKEY; QUAHOG, UNSPECIFIED; CRAB LEG, UNSPECIFIED; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; SCALLOP, UNSPECIFIED; AMANITA MUSCARIA FRUITING BODY; ONION; GARLIC; ANACARDIUM OCCIDENTALE FRUIT; LYCOPERDON UTRIFORME FRUITING BODY; CAFFEINE; CAPSICUM; CINNAMON; CYNARA SCOLYMUS LEAF; ALPINE STRAWBERRY; ABRUS PRECATORIUS SEED; GLYCYRRHIZA GLABRA; MENTHA PIPERITA; NUTMEG; LACTOSE; SUCROSE; BLACK MUSTARD SEED; SOLANUM NIGRUM WHOLE; ALLYLTHIOUREA; USTILAGO MAYDIS; GINGER; BRAZIL NUT; HAZELNUT, UNSPECIFIED; PEANUT; TROUT, UNSPECIFIED; COD, UNSPECIFIED; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; SOLANUM LYCOPERSICUM; SACCHARIN; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; URTICA URENS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 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; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 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</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; [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>Egg Proteins, Dietary [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Poultry Proteins [EXT],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Poultry Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],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 Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Food Additives [CS],Allergens [CS],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Plant Proteins [CS],Dietary Proteins [CS],Food Additives [CS],Seed Storage Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],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 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],Food Additives [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-06</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</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>