{
"NDC": [
{
"NDCCode": "62654-140-36",
"PackageDescription": "800 mL in 1 BOTTLE, PLASTIC (62654-140-36) ",
"NDC11Code": "62654-0140-36",
"ProductNDC": "62654-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermacen Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Central Solutions Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "64.5",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181205",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses."
},
{
"NDCCode": "62654-230-36",
"PackageDescription": "800 mL in 1 BOTTLE, PLASTIC (62654-230-36)",
"NDC11Code": "62654-0230-36",
"ProductNDC": "62654-230",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermacen Antimicrobial-t Hand",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Central Solutions Inc",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".375",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses. An effective antimicrobial hand cleanser. Kills and inhibits bacterial growth on hands. Gentle cleansers leave hands clean and moisturized. Reduces the possibility of cross-contamination."
},
{
"NDCCode": "62654-140-02",
"PackageDescription": "236 mL in 1 BOTTLE, PLASTIC (62654-140-02) ",
"NDC11Code": "62654-0140-02",
"ProductNDC": "62654-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermacen Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Central Solutions Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "64.5",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181205",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses."
},
{
"NDCCode": "62654-140-03",
"PackageDescription": "443 mL in 1 BOTTLE, PLASTIC (62654-140-03) ",
"NDC11Code": "62654-0140-03",
"ProductNDC": "62654-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermacen Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Central Solutions Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "64.5",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181205",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses."
},
{
"NDCCode": "62654-140-90",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (62654-140-90) ",
"NDC11Code": "62654-0140-90",
"ProductNDC": "62654-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermacen Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Central Solutions Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "64.5",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181205",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses."
},
{
"NDCCode": "62654-140-91",
"PackageDescription": "1000 mL in 1 BOTTLE (62654-140-91) ",
"NDC11Code": "62654-0140-91",
"ProductNDC": "62654-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermacen Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Central Solutions Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "64.5",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181205",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses."
},
{
"NDCCode": "62654-140-92",
"PackageDescription": "1250 mL in 1 BOTTLE, PLASTIC (62654-140-92) ",
"NDC11Code": "62654-0140-92",
"ProductNDC": "62654-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermacen Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Central Solutions Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "64.5",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181205",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses."
},
{
"NDCCode": "62654-140-93",
"PackageDescription": "2000 mL in 1 BOTTLE (62654-140-93) ",
"NDC11Code": "62654-0140-93",
"ProductNDC": "62654-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermacen Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Central Solutions Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "64.5",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181205",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses."
},
{
"NDCCode": "59779-140-36",
"PackageDescription": "177 mL in 1 BOTTLE, PLASTIC (59779-140-36)",
"NDC11Code": "59779-0140-36",
"ProductNDC": "59779-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Night Time Cherry",
"ProprietaryNameSuffix": "Pseudo-free",
"NonProprietaryName": "Doxylamine Succinate, Acetaminophen, Dextromethorphan Hydrobromide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090914",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "CVS",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "500; 15; 6.25",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2017-05-17"
},
{
"NDCCode": "62032-911-01",
"PackageDescription": "1 KIT in 1 CARTON (62032-911-01) * 48 g in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC (62032-100-36) * 1 TUBE in 1 CARTON (62032-140-09) / 85 g in 1 TUBE * 57 g in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC (62032-101-36) * 198 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "62032-0911-01",
"ProductNDC": "62032-911",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Obagi Nu-derm System Normal-dry Skin Transformation Kit",
"NonProprietaryName": "Hydroquinone, Homosalate, Octisalate, Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20210625",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Obagi Cosmeceuticals LLC",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210625",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "62032-912-01",
"PackageDescription": "1 KIT in 1 CARTON (62032-912-01) * 57 g in 1 BOTTLE, PLASTIC (62032-101-36) * 57 g in 1 BOTTLE, PLASTIC (62032-100-36) * 48 g in 1 BOTTLE, PLASTIC * 1 TUBE in 1 CARTON (62032-140-09) / 85 g in 1 TUBE * 198 mL in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "62032-0912-01",
"ProductNDC": "62032-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Obagi Nu-derm System Normal-oily Skin Transformation",
"NonProprietaryName": "Hydroquinone, Homosalate, Octisalate, Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20210625",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Obagi Cosmeceuticals LLC",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210625",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "62032-914-01",
"PackageDescription": "1 KIT in 1 KIT (62032-914-01) * 57 g in 1 BOTTLE, PLASTIC (62032-101-36) * 28 g in 1 BOTTLE, PLASTIC * 28 g in 1 BOTTLE, PLASTIC * 28 g in 1 TUBE (62032-140-05) * 59 mL in 1 BOTTLE, PLASTIC * 59 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "62032-0914-01",
"ProductNDC": "62032-914",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Obagi Nu-derm System Normal-oily Skin Transformation Trial",
"NonProprietaryName": "Hydroquinone, Homosalate, Octisalate, Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Obagi Cosmeceuticals LLC",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210625",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "62032-915-01",
"PackageDescription": "1 KIT in 1 KIT (62032-915-01) * 177 mL in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC * 30 mL in 1 BOTTLE, GLASS (62032-122-10) * 1 TUBE in 1 CARTON (62032-140-09) / 85 g in 1 TUBE * 57 g in 1 BOTTLE, PLASTIC (62032-105-36) ",
"NDC11Code": "62032-0915-01",
"ProductNDC": "62032-915",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Obagi-c C-rx System Normal-oily Skin Intervention",
"NonProprietaryName": "Hydroquinone, Homosalate, Octisalate, Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Obagi Cosmeceuticals LLC",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210625",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "62032-916-01",
"PackageDescription": "1 KIT in 1 CARTON (62032-916-01) * 1 TUBE in 1 CARTON (62032-140-09) / 85 g in 1 TUBE * 177 mL in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC (62032-105-36) * 1 BOTTLE, GLASS in 1 CARTON (62032-106-10) / 30 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62032-0916-01",
"ProductNDC": "62032-916",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Obagi-c C-rx System Normal-dry Skin Intervention",
"NonProprietaryName": "Hydroquinone, Homosalate, Octisalate, Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Obagi Cosmeceuticals LLC",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210625",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "68196-140-80",
"PackageDescription": "2.36 L in 1 BOTTLE (68196-140-80)",
"NDC11Code": "68196-0140-80",
"ProductNDC": "68196-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Sp With Light Moisturizers",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110118",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SAM'S WEST INC.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".115",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "74934-025-02",
"PackageDescription": "140 PATCH in 1 CANISTER (74934-025-02) / 4.36 mL in 1 PATCH",
"NDC11Code": "74934-0025-02",
"ProductNDC": "74934-025",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Color Element Antibacterial Wipes Saturated With 75 Ethyl Alcohol",
"NonProprietaryName": "Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200628",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Zhejiang iColor Biotech Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".75",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201126",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "79244-001-03",
"PackageDescription": "140 PATCH in 1 CANISTER (79244-001-03) > 3.36 mL in 1 PATCH",
"NDC11Code": "79244-0001-03",
"ProductNDC": "79244-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mosaic Bath And Spa Antibacterial Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200628",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Anhui Yunzhiyu Daily Chemical Products Co., Ltd",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200628",
"SamplePackage": "N"
},
{
"NDCCode": "79244-002-03",
"PackageDescription": "140 PATCH in 1 CANISTER (79244-002-03) > 3.36 mL in 1 PATCH",
"NDC11Code": "79244-0002-03",
"ProductNDC": "79244-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mosaic Bath And Spa Antibacterial Wipes, Lemon Scent",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200807",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Anhui Yunzhiyu Daily Chemical Products Co., Ltd",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200807",
"SamplePackage": "N"
},
{
"NDCCode": "0076-0111-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0076-0111-01)",
"NDC11Code": "00076-0111-01",
"ProductNDC": "0076-0111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uribel",
"NonProprietaryName": "Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100801",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Star Pharmaceuticals, LLC",
"SubstanceName": "METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE",
"StrengthNumber": "120; 40.8; 36; 10; .12",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uribel capsules indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.",
"Description": "Uribel capsules for oral administration. HYOSCYAMINE SULFATE. [620-61-1] [3(S)- endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Uribel capsules contain inactive ingredients: Dicalcium Phosphate, FD&C Blue #1, FD&C Red #3, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Propylene Glycol, Shellac, Silicon Dioxide, Sodium Hydroxide, Stearic Acid, and Titanium Dioxide."
},
{
"NDCCode": "0076-0111-02",
"PackageDescription": "20 POUCH in 1 BOX (0076-0111-02) > 1 CAPSULE in 1 POUCH",
"NDC11Code": "00076-0111-02",
"ProductNDC": "0076-0111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uribel",
"NonProprietaryName": "Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100801",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Star Pharmaceuticals, LLC",
"SubstanceName": "METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE",
"StrengthNumber": "120; 40.8; 36; 10; .12",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uribel capsules indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.",
"Description": "Uribel capsules for oral administration. HYOSCYAMINE SULFATE. [620-61-1] [3(S)- endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Uribel capsules contain inactive ingredients: Dicalcium Phosphate, FD&C Blue #1, FD&C Red #3, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Propylene Glycol, Shellac, Silicon Dioxide, Sodium Hydroxide, Stearic Acid, and Titanium Dioxide."
},
{
"NDCCode": "0076-0901-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0076-0901-01)",
"NDC11Code": "00076-0901-01",
"ProductNDC": "0076-0901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyophen",
"NonProprietaryName": "Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100921",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Star Pharmaceuticals, LLC",
"SubstanceName": "METHENAMINE; BENZOIC ACID; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE",
"StrengthNumber": "81.6; 9; 36.2; 10.8; .12",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Hyophen tablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.",
"Description": "Hyophen tablets for oral administration. HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 15.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 13ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. BENZOIC ACID. [65-85-0] Benzenecarboxylic acid; Benzeneformic acid; Benzenemethanoic acid. C 7H 6O 2; mol wt 122.12, C 68.85%, H 4.95%, O 26.20%. Exists as white powder or crystals, scales or needles. It has a strong odor and is slightly soluble in alcohol; also soluble in volatile and fixed oils, slightly soluble in petroleum ether. Hyophen tablets contain inactive ingredients: Crospovidone, FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Rice Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc, and Titanium Dioxide."
},
{
"NDCCode": "0076-0902-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0076-0902-01)",
"NDC11Code": "00076-0902-01",
"ProductNDC": "0076-0902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phosphasal",
"NonProprietaryName": "Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100921",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Star Pharmaceuticals, LLC",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; HYOSCYAMINE SULFATE; METHYLENE BLUE; METHENAMINE",
"StrengthNumber": "40.8; 36.2; .12; 10.8; 81.6",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Phosphasal tablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.",
"Description": "Phosphasal tablets for oral administration. HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt);3α-tropanyl S-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Phosphasal tablets contain inactive ingredients: Crospovidone, Dicalcium Phosphate, FD&C Blue #1 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc, and Titanium Dioxide."
},
{
"NDCCode": "0076-0903-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0076-0903-01)",
"NDC11Code": "00076-0903-01",
"ProductNDC": "0076-0903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ustell",
"NonProprietaryName": "Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100927",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Star Pharmaceuticals LLC",
"SubstanceName": "METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE",
"StrengthNumber": "120; 40.8; 36; 10; .12",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ustell capsules are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.",
"Description": "Ustell Capsules for oral administration. HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Ustell capsules contain inactive ingredients: Ammonium Hydroxide, Dicalcium Phosphate, FD&C Blue #1, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Propylene Glycol, Shellac, Silicon Dioxide, Simethicone, Stearic Acid, Titanium Dioxide."
},
{
"NDCCode": "0178-0740-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0178-0740-01) ",
"NDC11Code": "00178-0740-01",
"ProductNDC": "0178-0740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uribel",
"NonProprietaryName": "Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190415",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Mission Pharmacal Company",
"SubstanceName": "HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
"StrengthNumber": ".12; 118; 10; 36; 40.8",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190415",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Uribel ©capsules indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.",
"Description": "Uribel capsules for oral administration. HYOSCYAMINE SULFATE. [620-61-1] [3(S)- endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Uribel ©capsules contain inactive ingredients: Dicalcium Phosphate, FD&C Blue #1, FD&C Red #3, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Propylene Glycol, Shellac, Silicon Dioxide, Sodium Hydroxide, Stearic Acid, and Titanium Dioxide."
},
{
"NDCCode": "12539-144-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (12539-144-01) ",
"NDC11Code": "12539-0144-01",
"ProductNDC": "12539-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uretron D/s",
"NonProprietaryName": "Methenamine, Sodium Phosphate Monobasic, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221007",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; HYOSCYAMINE SULFATE; METHYLENE BLUE; METHENAMINE",
"StrengthNumber": "40.8; 36.2; .12; 10.8; 81.6",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221007",
"SamplePackage": "N",
"IndicationAndUsage": "Uretron D/Stablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.",
"Description": "Uretron D/S tablets for oral administration. HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt);3α-tropanyl S-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Uretron D/Stablets contain inactive ingredients: Crospovidone, Dicalcium Phosphate, FD&C Blue #1 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc, and Titanium Dioxide."
},
{
"NDCCode": "24470-967-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (24470-967-10) ",
"NDC11Code": "24470-0967-10",
"ProductNDC": "24470-967",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uribel Tabs",
"NonProprietaryName": "Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, Hyoscyamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20261005",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Cintex Services, LLC",
"SubstanceName": "METHENAMINE; BENZOIC ACID; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE",
"StrengthNumber": "81.6; 9; 36.2; 10.8; .12",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261005",
"SamplePackage": "N",
"IndicationAndUsage": "Uribel Tabs are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.",
"Description": "Uribel ® Tabs for oral administration. Each tablet contains. HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH, 5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethyleneimine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxychloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43°C. It is very slightly soluble in water and freely soluble in alcohol. BENZOIC ACID. [65-85-0] Benzenecarboxylic acid; Benzeneformic acid; Benzenemethanoic acid. C 7H 6O 2; mol wt 122.12, C 68.85%, H 4.95%, O 26.20%. Exists as white powder or crystals, scales or needles. It has a strong odor and is slightly soluble in alcohol; also soluble in volatile and fixed oils, slightly soluble in petroleum ether. Uribel Tabs contain inactive ingredients: Crospovidone, FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Rice Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc, and Titanium Dioxide."
},
{
"NDCCode": "24510-140-10",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-140-10) ",
"NDC11Code": "24510-0140-10",
"ProductNDC": "24510-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xtampza",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208090",
"LabelerName": "Collegium Pharmaceutical, Inc.",
"SubstanceName": "OXYCODONE",
"StrengthNumber": "36",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160510",
"SamplePackage": "N",
"IndicationAndUsage": "XTAMPZA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "XTAMPZA ER (oxycodone) extended-release capsules are an opioid agonist for oral use. The capsules contain microspheres formulated with oxycodone base and are supplied in strengths of 9 mg (equivalent to 10 mg oxycodone HCl), 13.5 mg (equivalent to 15 mg oxycodone HCl), 18 mg (equivalent to 20 mg oxycodone HCl), 27 mg (equivalent to 30 mg oxycodone HCl), and 36 mg (equivalent to 40 mg oxycodone HCl) capsules. The capsule strengths describe the amount of oxycodone base per capsule. The structural formula for oxycodone is as follows. C18H21NO4 MW 315.37 g/mol. The chemical name is 4,5 α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one. Oxycodone base is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone is present as myristate salt in the XTAMPZA ER formulation. Each XTAMPZA ER capsule contains either 9, 13.5, 18, 27, or 36 mg of oxycodone (equivalent to 10, 15, 20, 30, or 40 mg of oxycodone HCl, respectively) and the following inactive ingredients: myristic acid, yellow beeswax, carnauba wax, stearoyl polyoxyl-32 glycerides, magnesium stearate, and colloidal silicon dioxide. The capsule shells collectively contain titanium dioxide, hypromellose, and water. Additionally, the 9 mg and 18 mg strength capsule shells contain yellow iron oxide, the 13.5 and 36 mg strength capsule shells contain red iron oxide, and the 27 mg strength capsule shells contain black iron oxide."
},
{
"NDCCode": "24510-140-20",
"PackageDescription": "20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-140-20) ",
"NDC11Code": "24510-0140-20",
"ProductNDC": "24510-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xtampza",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208090",
"LabelerName": "Collegium Pharmaceutical, Inc.",
"SubstanceName": "OXYCODONE",
"StrengthNumber": "36",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160510",
"SamplePackage": "N",
"IndicationAndUsage": "XTAMPZA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "XTAMPZA ER (oxycodone) extended-release capsules are an opioid agonist for oral use. The capsules contain microspheres formulated with oxycodone base and are supplied in strengths of 9 mg (equivalent to 10 mg oxycodone HCl), 13.5 mg (equivalent to 15 mg oxycodone HCl), 18 mg (equivalent to 20 mg oxycodone HCl), 27 mg (equivalent to 30 mg oxycodone HCl), and 36 mg (equivalent to 40 mg oxycodone HCl) capsules. The capsule strengths describe the amount of oxycodone base per capsule. The structural formula for oxycodone is as follows. C18H21NO4 MW 315.37 g/mol. The chemical name is 4,5 α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one. Oxycodone base is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone is present as myristate salt in the XTAMPZA ER formulation. Each XTAMPZA ER capsule contains either 9, 13.5, 18, 27, or 36 mg of oxycodone (equivalent to 10, 15, 20, 30, or 40 mg of oxycodone HCl, respectively) and the following inactive ingredients: myristic acid, yellow beeswax, carnauba wax, stearoyl polyoxyl-32 glycerides, magnesium stearate, and colloidal silicon dioxide. The capsule shells collectively contain titanium dioxide, hypromellose, and water. Additionally, the 9 mg and 18 mg strength capsule shells contain yellow iron oxide, the 13.5 and 36 mg strength capsule shells contain red iron oxide, and the 27 mg strength capsule shells contain black iron oxide."
},
{
"NDCCode": "35356-439-36",
"PackageDescription": "36 TABLET in 1 BOTTLE (35356-439-36) ",
"NDC11Code": "35356-0439-36",
"ProductNDC": "35356-439",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091117",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076847",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221108",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"Description": "Sumatriptan tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 receptor subtype agonist. Sumatriptan succinate is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan succinate tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin."
},
{
"NDCCode": "49404-140-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (49404-140-02) > 50 mL in 1 CONTAINER (49404-140-01) ",
"NDC11Code": "49404-0140-02",
"ProductNDC": "49404-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr.jart Cicapair Tiger Grass Color Correcting Treatment",
"NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180502",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Have & Be Co., Ltd.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "2.36; 2.88",
"StrengthUnit": "mg/50mL; mg/50mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180502",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>62654-140-36</NDCCode>
<PackageDescription>800 mL in 1 BOTTLE, PLASTIC (62654-140-36) </PackageDescription>
<NDC11Code>62654-0140-36</NDC11Code>
<ProductNDC>62654-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermacen Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Central Solutions Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>64.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62654-230-36</NDCCode>
<PackageDescription>800 mL in 1 BOTTLE, PLASTIC (62654-230-36)</PackageDescription>
<NDC11Code>62654-0230-36</NDC11Code>
<ProductNDC>62654-230</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermacen Antimicrobial-t Hand</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Central Solutions Inc</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.375</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses. An effective antimicrobial hand cleanser. Kills and inhibits bacterial growth on hands. Gentle cleansers leave hands clean and moisturized. Reduces the possibility of cross-contamination.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62654-140-02</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PLASTIC (62654-140-02) </PackageDescription>
<NDC11Code>62654-0140-02</NDC11Code>
<ProductNDC>62654-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermacen Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Central Solutions Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>64.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62654-140-03</NDCCode>
<PackageDescription>443 mL in 1 BOTTLE, PLASTIC (62654-140-03) </PackageDescription>
<NDC11Code>62654-0140-03</NDC11Code>
<ProductNDC>62654-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermacen Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Central Solutions Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>64.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62654-140-90</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (62654-140-90) </PackageDescription>
<NDC11Code>62654-0140-90</NDC11Code>
<ProductNDC>62654-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermacen Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Central Solutions Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>64.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62654-140-91</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (62654-140-91) </PackageDescription>
<NDC11Code>62654-0140-91</NDC11Code>
<ProductNDC>62654-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermacen Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Central Solutions Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>64.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62654-140-92</NDCCode>
<PackageDescription>1250 mL in 1 BOTTLE, PLASTIC (62654-140-92) </PackageDescription>
<NDC11Code>62654-0140-92</NDC11Code>
<ProductNDC>62654-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermacen Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Central Solutions Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>64.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62654-140-93</NDCCode>
<PackageDescription>2000 mL in 1 BOTTLE (62654-140-93) </PackageDescription>
<NDC11Code>62654-0140-93</NDC11Code>
<ProductNDC>62654-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermacen Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Central Solutions Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>64.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. An antiseptic hand sanitizer for topical application. Prevents infection and cross contamination. Reduces transient microorganisms on intact skin. Keep hands from drying due to repeated uses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59779-140-36</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE, PLASTIC (59779-140-36)</PackageDescription>
<NDC11Code>59779-0140-36</NDC11Code>
<ProductNDC>59779-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Night Time Cherry</ProprietaryName>
<ProprietaryNameSuffix>Pseudo-free</ProprietaryNameSuffix>
<NonProprietaryName>Doxylamine Succinate, Acetaminophen, Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>CVS</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>500; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-05-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>62032-911-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (62032-911-01) * 48 g in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC (62032-100-36) * 1 TUBE in 1 CARTON (62032-140-09) / 85 g in 1 TUBE * 57 g in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC (62032-101-36) * 198 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>62032-0911-01</NDC11Code>
<ProductNDC>62032-911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Obagi Nu-derm System Normal-dry Skin Transformation Kit</ProprietaryName>
<NonProprietaryName>Hydroquinone, Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210625</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62032-912-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (62032-912-01) * 57 g in 1 BOTTLE, PLASTIC (62032-101-36) * 57 g in 1 BOTTLE, PLASTIC (62032-100-36) * 48 g in 1 BOTTLE, PLASTIC * 1 TUBE in 1 CARTON (62032-140-09) / 85 g in 1 TUBE * 198 mL in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>62032-0912-01</NDC11Code>
<ProductNDC>62032-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Obagi Nu-derm System Normal-oily Skin Transformation</ProprietaryName>
<NonProprietaryName>Hydroquinone, Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210625</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62032-914-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (62032-914-01) * 57 g in 1 BOTTLE, PLASTIC (62032-101-36) * 28 g in 1 BOTTLE, PLASTIC * 28 g in 1 BOTTLE, PLASTIC * 28 g in 1 TUBE (62032-140-05) * 59 mL in 1 BOTTLE, PLASTIC * 59 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>62032-0914-01</NDC11Code>
<ProductNDC>62032-914</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Obagi Nu-derm System Normal-oily Skin Transformation Trial</ProprietaryName>
<NonProprietaryName>Hydroquinone, Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62032-915-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (62032-915-01) * 177 mL in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC * 30 mL in 1 BOTTLE, GLASS (62032-122-10) * 1 TUBE in 1 CARTON (62032-140-09) / 85 g in 1 TUBE * 57 g in 1 BOTTLE, PLASTIC (62032-105-36) </PackageDescription>
<NDC11Code>62032-0915-01</NDC11Code>
<ProductNDC>62032-915</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Obagi-c C-rx System Normal-oily Skin Intervention</ProprietaryName>
<NonProprietaryName>Hydroquinone, Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62032-916-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (62032-916-01) * 1 TUBE in 1 CARTON (62032-140-09) / 85 g in 1 TUBE * 177 mL in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC (62032-105-36) * 1 BOTTLE, GLASS in 1 CARTON (62032-106-10) / 30 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62032-0916-01</NDC11Code>
<ProductNDC>62032-916</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Obagi-c C-rx System Normal-dry Skin Intervention</ProprietaryName>
<NonProprietaryName>Hydroquinone, Homosalate, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Obagi Cosmeceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68196-140-80</NDCCode>
<PackageDescription>2.36 L in 1 BOTTLE (68196-140-80)</PackageDescription>
<NDC11Code>68196-0140-80</NDC11Code>
<ProductNDC>68196-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Sp With Light Moisturizers</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SAM'S WEST INC.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.115</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>74934-025-02</NDCCode>
<PackageDescription>140 PATCH in 1 CANISTER (74934-025-02) / 4.36 mL in 1 PATCH</PackageDescription>
<NDC11Code>74934-0025-02</NDC11Code>
<ProductNDC>74934-025</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Color Element Antibacterial Wipes Saturated With 75 Ethyl Alcohol</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200628</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Zhejiang iColor Biotech Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201126</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79244-001-03</NDCCode>
<PackageDescription>140 PATCH in 1 CANISTER (79244-001-03) > 3.36 mL in 1 PATCH</PackageDescription>
<NDC11Code>79244-0001-03</NDC11Code>
<ProductNDC>79244-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mosaic Bath And Spa Antibacterial Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200628</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Anhui Yunzhiyu Daily Chemical Products Co., Ltd</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>79244-002-03</NDCCode>
<PackageDescription>140 PATCH in 1 CANISTER (79244-002-03) > 3.36 mL in 1 PATCH</PackageDescription>
<NDC11Code>79244-0002-03</NDC11Code>
<ProductNDC>79244-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mosaic Bath And Spa Antibacterial Wipes, Lemon Scent</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200807</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Anhui Yunzhiyu Daily Chemical Products Co., Ltd</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0076-0111-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0076-0111-01)</PackageDescription>
<NDC11Code>00076-0111-01</NDC11Code>
<ProductNDC>0076-0111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uribel</ProprietaryName>
<NonProprietaryName>Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Star Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>120; 40.8; 36; 10; .12</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uribel capsules indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.</IndicationAndUsage>
<Description>Uribel capsules for oral administration. HYOSCYAMINE SULFATE. [620-61-1] [3(S)- endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Uribel capsules contain inactive ingredients: Dicalcium Phosphate, FD&C Blue #1, FD&C Red #3, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Propylene Glycol, Shellac, Silicon Dioxide, Sodium Hydroxide, Stearic Acid, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0076-0111-02</NDCCode>
<PackageDescription>20 POUCH in 1 BOX (0076-0111-02) > 1 CAPSULE in 1 POUCH</PackageDescription>
<NDC11Code>00076-0111-02</NDC11Code>
<ProductNDC>0076-0111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uribel</ProprietaryName>
<NonProprietaryName>Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Star Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>120; 40.8; 36; 10; .12</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uribel capsules indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.</IndicationAndUsage>
<Description>Uribel capsules for oral administration. HYOSCYAMINE SULFATE. [620-61-1] [3(S)- endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Uribel capsules contain inactive ingredients: Dicalcium Phosphate, FD&C Blue #1, FD&C Red #3, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Propylene Glycol, Shellac, Silicon Dioxide, Sodium Hydroxide, Stearic Acid, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0076-0901-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0076-0901-01)</PackageDescription>
<NDC11Code>00076-0901-01</NDC11Code>
<ProductNDC>0076-0901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyophen</ProprietaryName>
<NonProprietaryName>Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100921</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Star Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METHENAMINE; BENZOIC ACID; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>81.6; 9; 36.2; 10.8; .12</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hyophen tablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.</IndicationAndUsage>
<Description>Hyophen tablets for oral administration. HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 15.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 13ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. BENZOIC ACID. [65-85-0] Benzenecarboxylic acid; Benzeneformic acid; Benzenemethanoic acid. C 7H 6O 2; mol wt 122.12, C 68.85%, H 4.95%, O 26.20%. Exists as white powder or crystals, scales or needles. It has a strong odor and is slightly soluble in alcohol; also soluble in volatile and fixed oils, slightly soluble in petroleum ether. Hyophen tablets contain inactive ingredients: Crospovidone, FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Rice Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0076-0902-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0076-0902-01)</PackageDescription>
<NDC11Code>00076-0902-01</NDC11Code>
<ProductNDC>0076-0902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phosphasal</ProprietaryName>
<NonProprietaryName>Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100921</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Star Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; HYOSCYAMINE SULFATE; METHYLENE BLUE; METHENAMINE</SubstanceName>
<StrengthNumber>40.8; 36.2; .12; 10.8; 81.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phosphasal tablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.</IndicationAndUsage>
<Description>Phosphasal tablets for oral administration. HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt);3α-tropanyl S-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Phosphasal tablets contain inactive ingredients: Crospovidone, Dicalcium Phosphate, FD&C Blue #1 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0076-0903-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0076-0903-01)</PackageDescription>
<NDC11Code>00076-0903-01</NDC11Code>
<ProductNDC>0076-0903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ustell</ProprietaryName>
<NonProprietaryName>Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100927</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Star Pharmaceuticals LLC</LabelerName>
<SubstanceName>METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>120; 40.8; 36; 10; .12</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ustell capsules are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.</IndicationAndUsage>
<Description>Ustell Capsules for oral administration. HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Ustell capsules contain inactive ingredients: Ammonium Hydroxide, Dicalcium Phosphate, FD&C Blue #1, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Propylene Glycol, Shellac, Silicon Dioxide, Simethicone, Stearic Acid, Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0178-0740-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0178-0740-01) </PackageDescription>
<NDC11Code>00178-0740-01</NDC11Code>
<ProductNDC>0178-0740</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uribel</ProprietaryName>
<NonProprietaryName>Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190415</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Mission Pharmacal Company</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE</SubstanceName>
<StrengthNumber>.12; 118; 10; 36; 40.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190415</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uribel ©capsules indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.</IndicationAndUsage>
<Description>Uribel capsules for oral administration. HYOSCYAMINE SULFATE. [620-61-1] [3(S)- endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Uribel ©capsules contain inactive ingredients: Dicalcium Phosphate, FD&C Blue #1, FD&C Red #3, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Propylene Glycol, Shellac, Silicon Dioxide, Sodium Hydroxide, Stearic Acid, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>12539-144-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (12539-144-01) </PackageDescription>
<NDC11Code>12539-0144-01</NDC11Code>
<ProductNDC>12539-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uretron D/s</ProprietaryName>
<NonProprietaryName>Methenamine, Sodium Phosphate Monobasic, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221007</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; HYOSCYAMINE SULFATE; METHYLENE BLUE; METHENAMINE</SubstanceName>
<StrengthNumber>40.8; 36.2; .12; 10.8; 81.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uretron D/Stablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.</IndicationAndUsage>
<Description>Uretron D/S tablets for oral administration. HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt);3α-tropanyl S-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol. SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO 4P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5. Uretron D/Stablets contain inactive ingredients: Crospovidone, Dicalcium Phosphate, FD&C Blue #1 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>24470-967-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (24470-967-10) </PackageDescription>
<NDC11Code>24470-0967-10</NDC11Code>
<ProductNDC>24470-967</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uribel Tabs</ProprietaryName>
<NonProprietaryName>Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261005</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Cintex Services, LLC</LabelerName>
<SubstanceName>METHENAMINE; BENZOIC ACID; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>81.6; 9; 36.2; 10.8; .12</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uribel Tabs are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.</IndicationAndUsage>
<Description>Uribel ® Tabs for oral administration. Each tablet contains. HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH, 5αH-tropan-3α-ol(-)-tropate(ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethyleneimine; Uritone; Urotropin. C 6H 12N 4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16H 18ClN 3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H 10O 3; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxychloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43°C. It is very slightly soluble in water and freely soluble in alcohol. BENZOIC ACID. [65-85-0] Benzenecarboxylic acid; Benzeneformic acid; Benzenemethanoic acid. C 7H 6O 2; mol wt 122.12, C 68.85%, H 4.95%, O 26.20%. Exists as white powder or crystals, scales or needles. It has a strong odor and is slightly soluble in alcohol; also soluble in volatile and fixed oils, slightly soluble in petroleum ether. Uribel Tabs contain inactive ingredients: Crospovidone, FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Rice Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc, and Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>24510-140-10</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-140-10) </PackageDescription>
<NDC11Code>24510-0140-10</NDC11Code>
<ProductNDC>24510-140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xtampza</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208090</ApplicationNumber>
<LabelerName>Collegium Pharmaceutical, Inc.</LabelerName>
<SubstanceName>OXYCODONE</SubstanceName>
<StrengthNumber>36</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XTAMPZA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>XTAMPZA ER (oxycodone) extended-release capsules are an opioid agonist for oral use. The capsules contain microspheres formulated with oxycodone base and are supplied in strengths of 9 mg (equivalent to 10 mg oxycodone HCl), 13.5 mg (equivalent to 15 mg oxycodone HCl), 18 mg (equivalent to 20 mg oxycodone HCl), 27 mg (equivalent to 30 mg oxycodone HCl), and 36 mg (equivalent to 40 mg oxycodone HCl) capsules. The capsule strengths describe the amount of oxycodone base per capsule. The structural formula for oxycodone is as follows. C18H21NO4 MW 315.37 g/mol. The chemical name is 4,5 α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one. Oxycodone base is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone is present as myristate salt in the XTAMPZA ER formulation. Each XTAMPZA ER capsule contains either 9, 13.5, 18, 27, or 36 mg of oxycodone (equivalent to 10, 15, 20, 30, or 40 mg of oxycodone HCl, respectively) and the following inactive ingredients: myristic acid, yellow beeswax, carnauba wax, stearoyl polyoxyl-32 glycerides, magnesium stearate, and colloidal silicon dioxide. The capsule shells collectively contain titanium dioxide, hypromellose, and water. Additionally, the 9 mg and 18 mg strength capsule shells contain yellow iron oxide, the 13.5 and 36 mg strength capsule shells contain red iron oxide, and the 27 mg strength capsule shells contain black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>24510-140-20</NDCCode>
<PackageDescription>20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-140-20) </PackageDescription>
<NDC11Code>24510-0140-20</NDC11Code>
<ProductNDC>24510-140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xtampza</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208090</ApplicationNumber>
<LabelerName>Collegium Pharmaceutical, Inc.</LabelerName>
<SubstanceName>OXYCODONE</SubstanceName>
<StrengthNumber>36</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XTAMPZA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>XTAMPZA ER (oxycodone) extended-release capsules are an opioid agonist for oral use. The capsules contain microspheres formulated with oxycodone base and are supplied in strengths of 9 mg (equivalent to 10 mg oxycodone HCl), 13.5 mg (equivalent to 15 mg oxycodone HCl), 18 mg (equivalent to 20 mg oxycodone HCl), 27 mg (equivalent to 30 mg oxycodone HCl), and 36 mg (equivalent to 40 mg oxycodone HCl) capsules. The capsule strengths describe the amount of oxycodone base per capsule. The structural formula for oxycodone is as follows. C18H21NO4 MW 315.37 g/mol. The chemical name is 4,5 α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one. Oxycodone base is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone is present as myristate salt in the XTAMPZA ER formulation. Each XTAMPZA ER capsule contains either 9, 13.5, 18, 27, or 36 mg of oxycodone (equivalent to 10, 15, 20, 30, or 40 mg of oxycodone HCl, respectively) and the following inactive ingredients: myristic acid, yellow beeswax, carnauba wax, stearoyl polyoxyl-32 glycerides, magnesium stearate, and colloidal silicon dioxide. The capsule shells collectively contain titanium dioxide, hypromellose, and water. Additionally, the 9 mg and 18 mg strength capsule shells contain yellow iron oxide, the 13.5 and 36 mg strength capsule shells contain red iron oxide, and the 27 mg strength capsule shells contain black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>35356-439-36</NDCCode>
<PackageDescription>36 TABLET in 1 BOTTLE (35356-439-36) </PackageDescription>
<NDC11Code>35356-0439-36</NDC11Code>
<ProductNDC>35356-439</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan Succinate</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091117</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076847</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221108</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sumatriptan tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 receptor subtype agonist. Sumatriptan succinate is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan succinate tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>49404-140-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (49404-140-02) > 50 mL in 1 CONTAINER (49404-140-01) </PackageDescription>
<NDC11Code>49404-0140-02</NDC11Code>
<ProductNDC>49404-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr.jart Cicapair Tiger Grass Color Correcting Treatment</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180502</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Have & Be Co., Ltd.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>2.36; 2.88</StrengthNumber>
<StrengthUnit>mg/50mL; mg/50mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>