{
"NDC": [
{
"NDCCode": "11822-1113-9",
"PackageDescription": "473 mL in 1 PACKAGE (11822-1113-9) ",
"NDC11Code": "11822-1113-09",
"ProductNDC": "11822-1113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen Spf 30",
"ProprietaryNameSuffix": "Daylogic",
"NonProprietaryName": "Avobenzone 2.00% Homosalate 10.50% Octisalate 5.00% Octocrylene 2.00% Oxybenzone 2.00%",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161130",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Rite Aid",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "2; 10.5; 5; 2; 2",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20161130",
"SamplePackage": "N",
"IndicationAndUsage": "Uses helps prevent sunburn."
},
{
"NDCCode": "11822-1113-6",
"PackageDescription": "236 mL in 1 PACKAGE (11822-1113-6) ",
"NDC11Code": "11822-1113-06",
"ProductNDC": "11822-1113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen Spf 30",
"ProprietaryNameSuffix": "Daylogic",
"NonProprietaryName": "Avobenzone 2.00% Homosalate 10.50% Octisalate 5.00% Octocrylene 2.00% Oxybenzone 2.00%",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161130",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Rite Aid",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "2; 10.5; 5; 2; 2",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20161130",
"SamplePackage": "N",
"IndicationAndUsage": "Uses helps prevent sunburn."
},
{
"NDCCode": "61601-1113-9",
"PackageDescription": "1 TUBE in 1 CARTON (61601-1113-9) > 50 mL in 1 TUBE",
"NDC11Code": "61601-1113-09",
"ProductNDC": "61601-1113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum Spf 15 Sunscreen",
"NonProprietaryName": "Titanium Dioxide And Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Space Brands Limited",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE",
"StrengthNumber": "3.1; 2.5",
"StrengthUnit": "g/50mL; g/50mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measure (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "71335-1113-9",
"PackageDescription": "20 TABLET in 1 BOTTLE (71335-1113-9) ",
"NDC11Code": "71335-1113-09",
"ProductNDC": "71335-1113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Senna-s",
"NonProprietaryName": "Sennosides And Docusate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DOCUSATE SODIUM; SENNOSIDES",
"StrengthNumber": "50; 8.6",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190304",
"SamplePackage": "N"
},
{
"NDCCode": "0074-2600-28",
"PackageDescription": "1 PACKET in 1 CARTON (0074-2600-28) / 28 PELLET in 1 PACKET",
"NDC11Code": "00074-2600-28",
"ProductNDC": "0074-2600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mavyret",
"NonProprietaryName": "Glecaprevir And Pibrentasvir",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210610",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215110",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PIBRENTASVIR; GLECAPREVIR",
"StrengthNumber": "20; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210622",
"SamplePackage": "N",
"IndicationAndUsage": "MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].",
"Description": "MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten. Glecaprevir/Pibrentasvir Coated Oral Pellets. MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten. Glecaprevir drug substance. The chemical name of glecaprevir is (3aR,7S,10S,12R,21E,24aR)-7-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1H,10H-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide hydrate. The molecular formula is C38H46F4N6O9S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:. Pibrentasvir drug substance. The chemical name of pibrentasvir is Methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C57H65F5N10O8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:."
},
{
"NDCCode": "0074-2625-01",
"PackageDescription": "1 DOSE PACK in 1 CARTON (0074-2625-01) / 3 TABLET, FILM COATED in 1 DOSE PACK",
"NDC11Code": "00074-2625-01",
"ProductNDC": "0074-2625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mavyret",
"NonProprietaryName": "Glecaprevir And Pibrentasvir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170803",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209394",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "GLECAPREVIR; PIBRENTASVIR",
"StrengthNumber": "100; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170803",
"EndMarketingDatePackage": "20250524",
"SamplePackage": "N",
"IndicationAndUsage": "MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].",
"Description": "MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten. Glecaprevir/Pibrentasvir Coated Oral Pellets. MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten. Glecaprevir drug substance. The chemical name of glecaprevir is (3aR,7S,10S,12R,21E,24aR)-7-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1H,10H-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide hydrate. The molecular formula is C38H46F4N6O9S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:. Pibrentasvir drug substance. The chemical name of pibrentasvir is Methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C57H65F5N10O8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:."
},
{
"NDCCode": "0074-2625-04",
"PackageDescription": "4 CARTON in 1 CARTON (0074-2625-04) / 7 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00074-2625-04",
"ProductNDC": "0074-2625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mavyret",
"NonProprietaryName": "Glecaprevir And Pibrentasvir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170803",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209394",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PIBRENTASVIR; GLECAPREVIR",
"StrengthNumber": "40; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250415",
"SamplePackage": "N",
"IndicationAndUsage": "MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].",
"Description": "MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten. Glecaprevir/Pibrentasvir Coated Oral Pellets. MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten. Glecaprevir drug substance. The chemical name of glecaprevir is (3aR,7S,10S,12R,21E,24aR)-7-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1H,10H-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide hydrate. The molecular formula is C38H46F4N6O9S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:. Pibrentasvir drug substance. The chemical name of pibrentasvir is Methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C57H65F5N10O8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:."
},
{
"NDCCode": "0074-2625-28",
"PackageDescription": "4 CARTON in 1 CARTON (0074-2625-28) / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK",
"NDC11Code": "00074-2625-28",
"ProductNDC": "0074-2625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mavyret",
"NonProprietaryName": "Glecaprevir And Pibrentasvir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170803",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209394",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PIBRENTASVIR; GLECAPREVIR",
"StrengthNumber": "40; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170803",
"EndMarketingDatePackage": "20300831",
"SamplePackage": "N",
"IndicationAndUsage": "MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].",
"Description": "MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten. Glecaprevir/Pibrentasvir Coated Oral Pellets. MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten. Glecaprevir drug substance. The chemical name of glecaprevir is (3aR,7S,10S,12R,21E,24aR)-7-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1H,10H-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide hydrate. The molecular formula is C38H46F4N6O9S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:. Pibrentasvir drug substance. The chemical name of pibrentasvir is Methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C57H65F5N10O8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:."
},
{
"NDCCode": "0074-2625-56",
"PackageDescription": "2 CARTON in 1 CARTON (0074-2625-56) / 4 CARTON in 1 CARTON / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK",
"NDC11Code": "00074-2625-56",
"ProductNDC": "0074-2625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mavyret",
"NonProprietaryName": "Glecaprevir And Pibrentasvir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170803",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209394",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PIBRENTASVIR; GLECAPREVIR",
"StrengthNumber": "40; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170803",
"SamplePackage": "N",
"IndicationAndUsage": "MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].",
"Description": "MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten. Glecaprevir/Pibrentasvir Coated Oral Pellets. MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten. Glecaprevir drug substance. The chemical name of glecaprevir is (3aR,7S,10S,12R,21E,24aR)-7-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1H,10H-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide hydrate. The molecular formula is C38H46F4N6O9S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:. Pibrentasvir drug substance. The chemical name of pibrentasvir is Methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C57H65F5N10O8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:."
},
{
"NDCCode": "0074-2625-84",
"PackageDescription": "84 TABLET, FILM COATED in 1 BOTTLE (0074-2625-84) ",
"NDC11Code": "00074-2625-84",
"ProductNDC": "0074-2625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mavyret",
"NonProprietaryName": "Glecaprevir And Pibrentasvir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170803",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209394",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PIBRENTASVIR; GLECAPREVIR",
"StrengthNumber": "40; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210622",
"SamplePackage": "N",
"IndicationAndUsage": "MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].",
"Description": "MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten. Glecaprevir/Pibrentasvir Coated Oral Pellets. MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten. Glecaprevir drug substance. The chemical name of glecaprevir is (3aR,7S,10S,12R,21E,24aR)-7-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1H,10H-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide hydrate. The molecular formula is C38H46F4N6O9S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:. Pibrentasvir drug substance. The chemical name of pibrentasvir is Methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C57H65F5N10O8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:."
},
{
"NDCCode": "22840-1113-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (22840-1113-1) ",
"NDC11Code": "22840-1113-01",
"ProductNDC": "22840-1113",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Gerbil Epithelia",
"NonProprietaryName": "Meriones Unguiculatus",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "MERIONES UNGUICULATUS SKIN",
"StrengthNumber": ".001",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "43742-1113-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-1113-1) ",
"NDC11Code": "43742-1113-01",
"ProductNDC": "43742-1113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sore Throat",
"NonProprietaryName": "Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla (smilax Regelii), Calcarea Phosphorica, Ferrum Iodatum, Lymph Nose (suis), Thyroidinum (suis)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171129",
"EndMarketingDate": "20240415",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "ARANEUS DIADEMATUS; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PINUS SYLVESTRIS LEAFY TWIG; SCROPHULARIA NODOSA; SMILAX ORNATA ROOT; SODIUM SULFATE; SUS SCROFA LYMPH; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "6; 4; 12; 4; 5; 4; 5; 5; 9; 4; 4; 3; 6; 4; 12; 12; 3; 12; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171129",
"EndMarketingDatePackage": "20240415",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of symptoms related to both bacterial and viral throat infection including cough, sneezing, and pain.**. **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "76485-1113-1",
"PackageDescription": "30 mL in 1 BOTTLE (76485-1113-1) ",
"NDC11Code": "76485-1113-01",
"ProductNDC": "76485-1113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rimmel Bb Cream Beauty Balm Matte 9-in-1 Skin Perfecting Super Makeup Spf 15",
"NonProprietaryName": "Octinoxate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200316",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Rimmel Inc",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE",
"StrengthNumber": "7; 1",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200316",
"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": "76485-1113-2",
"PackageDescription": "30 mL in 1 BOTTLE (76485-1113-2) ",
"NDC11Code": "76485-1113-02",
"ProductNDC": "76485-1113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rimmel Bb Cream Beauty Balm Matte 9-in-1 Skin Perfecting Super Makeup Spf 15",
"NonProprietaryName": "Octinoxate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200316",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Rimmel Inc",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE",
"StrengthNumber": "7; 1",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200316",
"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": "76485-1113-3",
"PackageDescription": "30 mL in 1 BOTTLE (76485-1113-3) ",
"NDC11Code": "76485-1113-03",
"ProductNDC": "76485-1113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rimmel Bb Cream Beauty Balm Matte 9-in-1 Skin Perfecting Super Makeup Spf 15",
"NonProprietaryName": "Octinoxate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200316",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Rimmel Inc",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE",
"StrengthNumber": "7; 1",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200316",
"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": "11822-0014-9",
"PackageDescription": "1 TUBE in 1 CARTON (11822-0014-9) / 96.4 g in 1 TUBE",
"NDC11Code": "11822-0014-09",
"ProductNDC": "11822-0014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sensitive Rapid Relief",
"NonProprietaryName": "Stannous Fluoride",
"DosageFormName": "PASTE",
"RouteName": "DENTAL",
"StartMarketingDate": "20200602",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Rite Aid",
"SubstanceName": "STANNOUS FLUORIDE",
"StrengthNumber": ".15",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200602",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "aids in teh prevention of dental cavities * builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact."
},
{
"NDCCode": "11822-0101-9",
"PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (11822-0101-9) * 10 TABLET, FILM COATED in 1 BLISTER PACK * 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "11822-0101-09",
"ProductNDC": "11822-0101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Multi-symptom Cold And Cough Daytime Nighttime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20070222",
"EndMarketingDate": "20190415",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Rite Aid Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-04-16",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "11822-0119-9",
"PackageDescription": "9 mL in 1 BOTTLE, WITH APPLICATOR (11822-0119-9) ",
"NDC11Code": "11822-0119-09",
"ProductNDC": "11822-0119",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Liquid Wart Remover",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171222",
"EndMarketingDate": "20260620",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M028",
"LabelerName": "RITE AID CORPORATION",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".17",
"StrengthUnit": "g/9mL",
"Status": "Deprecated",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171222",
"EndMarketingDatePackage": "20260620",
"SamplePackage": "N",
"IndicationAndUsage": "for the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. Plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern."
},
{
"NDCCode": "11822-0120-9",
"PackageDescription": "9.8 mL in 1 BOTTLE, WITH APPLICATOR (11822-0120-9) ",
"NDC11Code": "11822-0120-09",
"ProductNDC": "11822-0120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Corn And Callus Remover Liquid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171222",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M030",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".17",
"StrengthUnit": "mg/9.8mL",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171222",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "for the removal of corns and calluses. relieves pain by removing corns and calluses."
},
{
"NDCCode": "11822-0127-9",
"PackageDescription": "9 PATCH in 1 PACKAGE (11822-0127-9) ",
"NDC11Code": "11822-0127-09",
"ProductNDC": "11822-0127",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Medicated Corn Removers",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171222",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M030",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "40",
"StrengthUnit": "mg/91",
"Status": "Deprecated",
"LastUpdate": "2025-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171222",
"SamplePackage": "N",
"IndicationAndUsage": "for the removal of corns. relieves pain by removing corns."
},
{
"NDCCode": "11822-0128-9",
"PackageDescription": "9 mL in 1 BOTTLE, WITH APPLICATOR (11822-0128-9) ",
"NDC11Code": "11822-0128-09",
"ProductNDC": "11822-0128",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benzethonium Chloride Plus Dyclonine Hydrochloride",
"NonProprietaryName": "Liquid Bandage",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171222",
"EndMarketingDate": "20261120",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE",
"StrengthNumber": ".2; .75",
"StrengthUnit": "mg/9mL; mg/9mL",
"Status": "Active",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171222",
"EndMarketingDatePackage": "20261120",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to prevent bacteria contamination in minor cuts and scrapes."
},
{
"NDCCode": "11822-0132-9",
"PackageDescription": "9 PATCH in 1 PACKAGE (11822-0132-9) ",
"NDC11Code": "11822-0132-09",
"ProductNDC": "11822-0132",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Ultra Thin Corn Removers",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171222",
"EndMarketingDate": "20260920",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M030",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "40",
"StrengthUnit": "mg/91",
"Status": "Active",
"LastUpdate": "2025-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171222",
"EndMarketingDatePackage": "20260920",
"SamplePackage": "N",
"IndicationAndUsage": "for the removal of corns. relieves pain by removing corns."
},
{
"NDCCode": "11822-0189-3",
"PackageDescription": "9 BLISTER PACK in 1 CARTON (11822-0189-3) > 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "11822-0189-03",
"ProductNDC": "11822-0189",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900410",
"EndMarketingDate": "20211224",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part338",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19900410",
"EndMarketingDatePackage": "20211224",
"SamplePackage": "N"
},
{
"NDCCode": "11822-0189-9",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (11822-0189-9) > 16 TABLET in 1 BLISTER PACK",
"NDC11Code": "11822-0189-09",
"ProductNDC": "11822-0189",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19921225",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Rite Aid",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-08-29"
},
{
"NDCCode": "11822-0199-0",
"PackageDescription": "1 KIT in 1 CARTON (11822-0199-0) * 1 INSERT in 1 POUCH * 9 g in 1 TUBE",
"NDC11Code": "11822-0199-00",
"ProductNDC": "11822-0199",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Miconazole 1",
"ProprietaryNameSuffix": "Feminine Care",
"NonProprietaryName": "Miconazole Nitrate",
"DosageFormName": "KIT",
"StartMarketingDate": "20100609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079114",
"LabelerName": "Rite Aid Corporation",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100609",
"SamplePackage": "N",
"IndicationAndUsage": "treats vaginal yeast infections. relieves external itching and irritation due to a vaginal yeast infection."
},
{
"NDCCode": "11822-0209-0",
"PackageDescription": "1 KIT in 1 CARTON (11822-0209-0) * 3 BLISTER PACK in 1 KIT (0113-6650-00) / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBE",
"NDC11Code": "11822-0209-00",
"ProductNDC": "11822-0209",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Miconazole 3",
"NonProprietaryName": "Miconazole Nitrate",
"DosageFormName": "KIT",
"StartMarketingDate": "20231109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075329",
"LabelerName": "Rite Aid Corporation",
"Status": "Active",
"LastUpdate": "2023-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231109",
"SamplePackage": "N",
"IndicationAndUsage": "treats vaginal yeast infections . relieves external itching and irritation due to a vaginal yeast infection."
},
{
"NDCCode": "11822-0216-9",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (11822-0216-9) ",
"NDC11Code": "11822-0216-09",
"ProductNDC": "11822-0216",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rite Aid Extra Strength",
"ProprietaryNameSuffix": "Tropical Fruit",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190314",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190314",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "11822-0291-9",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (11822-0291-9) > 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "11822-0291-09",
"ProductNDC": "11822-0291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075010",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19880524",
"SamplePackage": "N"
},
{
"NDCCode": "11822-0306-9",
"PackageDescription": "10 PACKET in 1 CARTON (11822-0306-9) / 17 g in 1 PACKET (11822-0306-0) ",
"NDC11Code": "11822-0306-09",
"ProductNDC": "11822-0306",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laxative",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091009",
"EndMarketingDate": "20271231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090685",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/17g",
"Pharm_Classes": "Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20091009",
"EndMarketingDatePackage": "20260801",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days."
},
{
"NDCCode": "11822-0316-3",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (11822-0316-3) / 9 g in 1 TUBE",
"NDC11Code": "11822-0316-03",
"ProductNDC": "11822-0316",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rite Aid",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "ORAL",
"StartMarketingDate": "20110120",
"EndMarketingDate": "20261130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Rite Aid",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": "20",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190303",
"EndMarketingDatePackage": "20261130",
"SamplePackage": "N",
"IndicationAndUsage": "Use. temporarily relieves pain associated with mouth and gum irritations."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>11822-1113-9</NDCCode>
<PackageDescription>473 mL in 1 PACKAGE (11822-1113-9) </PackageDescription>
<NDC11Code>11822-1113-09</NDC11Code>
<ProductNDC>11822-1113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen Spf 30</ProprietaryName>
<ProprietaryNameSuffix>Daylogic</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone 2.00% Homosalate 10.50% Octisalate 5.00% Octocrylene 2.00% Oxybenzone 2.00%</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Rite Aid</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>2; 10.5; 5; 2; 2</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-1113-6</NDCCode>
<PackageDescription>236 mL in 1 PACKAGE (11822-1113-6) </PackageDescription>
<NDC11Code>11822-1113-06</NDC11Code>
<ProductNDC>11822-1113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen Spf 30</ProprietaryName>
<ProprietaryNameSuffix>Daylogic</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone 2.00% Homosalate 10.50% Octisalate 5.00% Octocrylene 2.00% Oxybenzone 2.00%</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Rite Aid</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>2; 10.5; 5; 2; 2</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61601-1113-9</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (61601-1113-9) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>61601-1113-09</NDC11Code>
<ProductNDC>61601-1113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum Spf 15 Sunscreen</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Space Brands Limited</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>3.1; 2.5</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measure (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-1113-9</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (71335-1113-9) </PackageDescription>
<NDC11Code>71335-1113-09</NDC11Code>
<ProductNDC>71335-1113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna-s</ProprietaryName>
<NonProprietaryName>Sennosides And Docusate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DOCUSATE SODIUM; SENNOSIDES</SubstanceName>
<StrengthNumber>50; 8.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0074-2600-28</NDCCode>
<PackageDescription>1 PACKET in 1 CARTON (0074-2600-28) / 28 PELLET in 1 PACKET</PackageDescription>
<NDC11Code>00074-2600-28</NDC11Code>
<ProductNDC>0074-2600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mavyret</ProprietaryName>
<NonProprietaryName>Glecaprevir And Pibrentasvir</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210610</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215110</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PIBRENTASVIR; GLECAPREVIR</SubstanceName>
<StrengthNumber>20; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].</IndicationAndUsage>
<Description>MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten. Glecaprevir/Pibrentasvir Coated Oral Pellets. MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten. Glecaprevir drug substance. The chemical name of glecaprevir is (3aR,7S,10S,12R,21E,24aR)-7-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1H,10H-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide hydrate. The molecular formula is C38H46F4N6O9S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:. Pibrentasvir drug substance. The chemical name of pibrentasvir is Methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C57H65F5N10O8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:.</Description>
</NDC>
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<NDCCode>0074-2625-01</NDCCode>
<PackageDescription>1 DOSE PACK in 1 CARTON (0074-2625-01) / 3 TABLET, FILM COATED in 1 DOSE PACK</PackageDescription>
<NDC11Code>00074-2625-01</NDC11Code>
<ProductNDC>0074-2625</ProductNDC>
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<ProprietaryName>Mavyret</ProprietaryName>
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<ApplicationNumber>NDA209394</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>GLECAPREVIR; PIBRENTASVIR</SubstanceName>
<StrengthNumber>100; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
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<IndicationAndUsage>MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].</IndicationAndUsage>
<Description>MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten. Glecaprevir/Pibrentasvir Coated Oral Pellets. MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten. Glecaprevir drug substance. The chemical name of glecaprevir is (3aR,7S,10S,12R,21E,24aR)-7-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1H,10H-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide hydrate. The molecular formula is C38H46F4N6O9S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:. Pibrentasvir drug substance. The chemical name of pibrentasvir is Methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C57H65F5N10O8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:.</Description>
</NDC>
<NDC>
<NDCCode>0074-2625-04</NDCCode>
<PackageDescription>4 CARTON in 1 CARTON (0074-2625-04) / 7 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>0074-2625</ProductNDC>
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<ProprietaryName>Mavyret</ProprietaryName>
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<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PIBRENTASVIR; GLECAPREVIR</SubstanceName>
<StrengthNumber>40; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2026-08-08</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].</IndicationAndUsage>
<Description>MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten. Glecaprevir/Pibrentasvir Coated Oral Pellets. MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten. Glecaprevir drug substance. The chemical name of glecaprevir is (3aR,7S,10S,12R,21E,24aR)-7-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1H,10H-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide hydrate. The molecular formula is C38H46F4N6O9S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:. Pibrentasvir drug substance. The chemical name of pibrentasvir is Methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C57H65F5N10O8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:.</Description>
</NDC>
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<PackageDescription>4 CARTON in 1 CARTON (0074-2625-28) / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK</PackageDescription>
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<LabelerName>AbbVie Inc.</LabelerName>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
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<EndMarketingDatePackage>20300831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].</IndicationAndUsage>
<Description>MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten. Glecaprevir/Pibrentasvir Coated Oral Pellets. MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten. Glecaprevir drug substance. The chemical name of glecaprevir is (3aR,7S,10S,12R,21E,24aR)-7-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1H,10H-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide hydrate. The molecular formula is C38H46F4N6O9S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:. Pibrentasvir drug substance. The chemical name of pibrentasvir is Methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C57H65F5N10O8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:.</Description>
</NDC>
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<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].</IndicationAndUsage>
<Description>MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten. Glecaprevir/Pibrentasvir Coated Oral Pellets. MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten. Glecaprevir drug substance. The chemical name of glecaprevir is (3aR,7S,10S,12R,21E,24aR)-7-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1H,10H-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide hydrate. The molecular formula is C38H46F4N6O9S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:. Pibrentasvir drug substance. The chemical name of pibrentasvir is Methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C57H65F5N10O8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:.</Description>
</NDC>
<NDC>
<NDCCode>0074-2625-84</NDCCode>
<PackageDescription>84 TABLET, FILM COATED in 1 BOTTLE (0074-2625-84) </PackageDescription>
<NDC11Code>00074-2625-84</NDC11Code>
<ProductNDC>0074-2625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mavyret</ProprietaryName>
<NonProprietaryName>Glecaprevir And Pibrentasvir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170803</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209394</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PIBRENTASVIR; GLECAPREVIR</SubstanceName>
<StrengthNumber>40; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].</IndicationAndUsage>
<Description>MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten. Glecaprevir/Pibrentasvir Coated Oral Pellets. MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate. The oral pellets do not contain gluten. Glecaprevir drug substance. The chemical name of glecaprevir is (3aR,7S,10S,12R,21E,24aR)-7-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1H,10H-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide hydrate. The molecular formula is C38H46F4N6O9S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate). The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure:. Pibrentasvir drug substance. The chemical name of pibrentasvir is Methyl {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2S)-1-[N-(methoxycarbonyl)-O-methyl-L-threonyl]pyrrolidin-2-yl}-1H-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1H-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate. The molecular formula is C57H65F5N10O8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure:.</Description>
</NDC>
<NDC>
<NDCCode>22840-1113-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (22840-1113-1) </PackageDescription>
<NDC11Code>22840-1113-01</NDC11Code>
<ProductNDC>22840-1113</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Gerbil Epithelia</ProprietaryName>
<NonProprietaryName>Meriones Unguiculatus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>MERIONES UNGUICULATUS SKIN</SubstanceName>
<StrengthNumber>.001</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>43742-1113-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-1113-1) </PackageDescription>
<NDC11Code>43742-1113-01</NDC11Code>
<ProductNDC>43742-1113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sore Throat</ProprietaryName>
<NonProprietaryName>Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla (smilax Regelii), Calcarea Phosphorica, Ferrum Iodatum, Lymph Nose (suis), Thyroidinum (suis)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171129</StartMarketingDate>
<EndMarketingDate>20240415</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>ARANEUS DIADEMATUS; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PINUS SYLVESTRIS LEAFY TWIG; SCROPHULARIA NODOSA; SMILAX ORNATA ROOT; SODIUM SULFATE; SUS SCROFA LYMPH; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>6; 4; 12; 4; 5; 4; 5; 5; 9; 4; 4; 3; 6; 4; 12; 12; 3; 12; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171129</StartMarketingDatePackage>
<EndMarketingDatePackage>20240415</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of symptoms related to both bacterial and viral throat infection including cough, sneezing, and pain.**. **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76485-1113-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (76485-1113-1) </PackageDescription>
<NDC11Code>76485-1113-01</NDC11Code>
<ProductNDC>76485-1113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rimmel Bb Cream Beauty Balm Matte 9-in-1 Skin Perfecting Super Makeup Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200316</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Rimmel Inc</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>7; 1</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200316</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>76485-1113-2</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (76485-1113-2) </PackageDescription>
<NDC11Code>76485-1113-02</NDC11Code>
<ProductNDC>76485-1113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rimmel Bb Cream Beauty Balm Matte 9-in-1 Skin Perfecting Super Makeup Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200316</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Rimmel Inc</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>7; 1</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200316</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>76485-1113-3</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (76485-1113-3) </PackageDescription>
<NDC11Code>76485-1113-03</NDC11Code>
<ProductNDC>76485-1113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rimmel Bb Cream Beauty Balm Matte 9-in-1 Skin Perfecting Super Makeup Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200316</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Rimmel Inc</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>7; 1</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200316</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>11822-0014-9</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (11822-0014-9) / 96.4 g in 1 TUBE</PackageDescription>
<NDC11Code>11822-0014-09</NDC11Code>
<ProductNDC>11822-0014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sensitive Rapid Relief</ProprietaryName>
<NonProprietaryName>Stannous Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20200602</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Rite Aid</LabelerName>
<SubstanceName>STANNOUS FLUORIDE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200602</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in teh prevention of dental cavities * builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0101-9</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (11822-0101-9) * 10 TABLET, FILM COATED in 1 BLISTER PACK * 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11822-0101-09</NDC11Code>
<ProductNDC>11822-0101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Multi-symptom Cold And Cough Daytime Nighttime</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20070222</StartMarketingDate>
<EndMarketingDate>20190415</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-04-16</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>11822-0119-9</NDCCode>
<PackageDescription>9 mL in 1 BOTTLE, WITH APPLICATOR (11822-0119-9) </PackageDescription>
<NDC11Code>11822-0119-09</NDC11Code>
<ProductNDC>11822-0119</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Liquid Wart Remover</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171222</StartMarketingDate>
<EndMarketingDate>20260620</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M028</ApplicationNumber>
<LabelerName>RITE AID CORPORATION</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.17</StrengthNumber>
<StrengthUnit>g/9mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171222</StartMarketingDatePackage>
<EndMarketingDatePackage>20260620</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. Plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0120-9</NDCCode>
<PackageDescription>9.8 mL in 1 BOTTLE, WITH APPLICATOR (11822-0120-9) </PackageDescription>
<NDC11Code>11822-0120-09</NDC11Code>
<ProductNDC>11822-0120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Corn And Callus Remover Liquid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171222</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M030</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.17</StrengthNumber>
<StrengthUnit>mg/9.8mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171222</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the removal of corns and calluses. relieves pain by removing corns and calluses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0127-9</NDCCode>
<PackageDescription>9 PATCH in 1 PACKAGE (11822-0127-9) </PackageDescription>
<NDC11Code>11822-0127-09</NDC11Code>
<ProductNDC>11822-0127</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Medicated Corn Removers</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171222</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M030</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/91</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the removal of corns. relieves pain by removing corns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0128-9</NDCCode>
<PackageDescription>9 mL in 1 BOTTLE, WITH APPLICATOR (11822-0128-9) </PackageDescription>
<NDC11Code>11822-0128-09</NDC11Code>
<ProductNDC>11822-0128</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benzethonium Chloride Plus Dyclonine Hydrochloride</ProprietaryName>
<NonProprietaryName>Liquid Bandage</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171222</StartMarketingDate>
<EndMarketingDate>20261120</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2; .75</StrengthNumber>
<StrengthUnit>mg/9mL; mg/9mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171222</StartMarketingDatePackage>
<EndMarketingDatePackage>20261120</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to prevent bacteria contamination in minor cuts and scrapes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0132-9</NDCCode>
<PackageDescription>9 PATCH in 1 PACKAGE (11822-0132-9) </PackageDescription>
<NDC11Code>11822-0132-09</NDC11Code>
<ProductNDC>11822-0132</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Ultra Thin Corn Removers</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171222</StartMarketingDate>
<EndMarketingDate>20260920</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M030</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/91</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171222</StartMarketingDatePackage>
<EndMarketingDatePackage>20260920</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the removal of corns. relieves pain by removing corns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0189-3</NDCCode>
<PackageDescription>9 BLISTER PACK in 1 CARTON (11822-0189-3) > 8 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11822-0189-03</NDC11Code>
<ProductNDC>11822-0189</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900410</StartMarketingDate>
<EndMarketingDate>20211224</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19900410</StartMarketingDatePackage>
<EndMarketingDatePackage>20211224</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11822-0189-9</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (11822-0189-9) > 16 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11822-0189-09</NDC11Code>
<ProductNDC>11822-0189</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19921225</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Rite Aid</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>11822-0199-0</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (11822-0199-0) * 1 INSERT in 1 POUCH * 9 g in 1 TUBE</PackageDescription>
<NDC11Code>11822-0199-00</NDC11Code>
<ProductNDC>11822-0199</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Miconazole 1</ProprietaryName>
<ProprietaryNameSuffix>Feminine Care</ProprietaryNameSuffix>
<NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079114</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats vaginal yeast infections. relieves external itching and irritation due to a vaginal yeast infection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0209-0</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (11822-0209-0) * 3 BLISTER PACK in 1 KIT (0113-6650-00) / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBE</PackageDescription>
<NDC11Code>11822-0209-00</NDC11Code>
<ProductNDC>11822-0209</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Miconazole 3</ProprietaryName>
<NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075329</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats vaginal yeast infections . relieves external itching and irritation due to a vaginal yeast infection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0216-9</NDCCode>
<PackageDescription>96 TABLET, CHEWABLE in 1 BOTTLE (11822-0216-9) </PackageDescription>
<NDC11Code>11822-0216-09</NDC11Code>
<ProductNDC>11822-0216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rite Aid Extra Strength</ProprietaryName>
<ProprietaryNameSuffix>Tropical Fruit</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190314</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0291-9</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (11822-0291-9) > 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>11822-0291-09</NDC11Code>
<ProductNDC>11822-0291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075010</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11822-0306-9</NDCCode>
<PackageDescription>10 PACKET in 1 CARTON (11822-0306-9) / 17 g in 1 PACKET (11822-0306-0) </PackageDescription>
<NDC11Code>11822-0306-09</NDC11Code>
<ProductNDC>11822-0306</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laxative</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091009</StartMarketingDate>
<EndMarketingDate>20271231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090685</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/17g</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20091009</StartMarketingDatePackage>
<EndMarketingDatePackage>20260801</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0316-3</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (11822-0316-3) / 9 g in 1 TUBE</PackageDescription>
<NDC11Code>11822-0316-03</NDC11Code>
<ProductNDC>11822-0316</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rite Aid</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110120</StartMarketingDate>
<EndMarketingDate>20261130</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Rite Aid</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190303</StartMarketingDatePackage>
<EndMarketingDatePackage>20261130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. temporarily relieves pain associated with mouth and gum irritations.</IndicationAndUsage>
</NDC>
</NDCList>