{
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"PackageDescription": "10 POUCH in 1 CARTON (66715-9727-8) > 2 TABLET in 1 POUCH",
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"ProductNDC": "66715-9727",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lil Drug Store Allergy Sinus Relief",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride",
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"ApplicationNumber": "part341",
"LabelerName": "Lil' Drug Store Products, Inc.",
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"StrengthUnit": "mg/1; mg/1; mg/1",
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"LastUpdate": "2018-01-19",
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},
{
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"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-8) ",
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"ProductNDC": "71335-9727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "Bryant Ranch Prepack",
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"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
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"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
"NDCCode": "66715-9727-3",
"PackageDescription": "3 POUCH in 1 CARTON (66715-9727-3) > 2 TABLET in 1 POUCH",
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"ProductNDC": "66715-9727",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lil Drug Store Allergy Sinus Relief",
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"DosageFormName": "TABLET",
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"StartMarketingDate": "20110208",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 2; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N"
},
{
"NDCCode": "66715-9727-4",
"PackageDescription": "30 POUCH in 1 CARTON (66715-9727-4) > 2 TABLET in 1 POUCH",
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"ProductNDC": "66715-9727",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lil Drug Store Allergy Sinus Relief",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 2; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "71335-9727-0",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-0) ",
"NDC11Code": "71335-9727-00",
"ProductNDC": "71335-9727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090162",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20240405",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
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"ProductNDC": "71335-9727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090162",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TOPIRAMATE",
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"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
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"ProductNDC": "71335-9727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090162",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TOPIRAMATE",
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"Status": "Active",
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"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
"NDCCode": "71335-9727-3",
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"ProductNDC": "71335-9727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
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"RouteName": "ORAL",
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"LabelerName": "Bryant Ranch Prepack",
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"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
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"ProductNDC": "71335-9727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ApplicationNumber": "ANDA090162",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TOPIRAMATE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
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"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"ApplicationNumber": "ANDA090162",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TOPIRAMATE",
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"Status": "Active",
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"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
"NDCCode": "71335-9727-6",
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"ProductNDC": "71335-9727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090162",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-08-10",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
"NDCCode": "71335-9727-7",
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"NDC11Code": "71335-9727-07",
"ProductNDC": "71335-9727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090162",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-08-10",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
"NDCCode": "71335-9727-9",
"PackageDescription": "45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-9) ",
"NDC11Code": "71335-9727-09",
"ProductNDC": "71335-9727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090162",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240405",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
"NDCCode": "66715-5154-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (66715-5154-8) / 12 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "66715-5154-08",
"ProductNDC": "66715-5154",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy, Circle K",
"NonProprietaryName": "Diphenhydramine Hcl 25mg Tablet",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210712",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210712",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. itchy, watery eyes. itching of the nose or throat. sneezing. temporarily relieves these symptoms due to the common cold:. runny nose. sneezing."
},
{
"NDCCode": "66715-5254-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (66715-5254-8) > 12 TABLET in 1 BLISTER PACK",
"NDC11Code": "66715-5254-08",
"ProductNDC": "66715-5254",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy",
"ProprietaryNameSuffix": "Circle K",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150110",
"EndMarketingDate": "20241104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200529",
"EndMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nosesneezingitchy, watery eyesitching of the nose or throat. temporarily relieves these symptoms due to the common cold runny nosesneezing."
},
{
"NDCCode": "66715-5503-8",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (66715-5503-8) / 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "66715-5503-08",
"ProductNDC": "66715-5503",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep-aid, Circle K",
"NonProprietaryName": "Diphenhydramine Hcl Caplet, 25mg",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211220",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 for relief of occasional sleeplessness, 2 reduces time to fall asleep if you have difficulty falling asleep."
},
{
"NDCCode": "66715-5570-8",
"PackageDescription": "251 mL in 1 BOTTLE, PLASTIC (66715-5570-8) ",
"NDC11Code": "66715-5570-08",
"ProductNDC": "66715-5570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Blue Mint",
"NonProprietaryName": "Eucalyptol, Menthol, Merthyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20190107",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "LIL' DRUG STORE PRODUCTS, INC.",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".92; .42; .6; .64",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190107",
"SamplePackage": "N",
"IndicationAndUsage": "Helps reduce plaque that leads to : 1 gingivitis, 2 bleeding gums."
},
{
"NDCCode": "66715-5571-8",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (66715-5571-8) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "66715-5571-08",
"ProductNDC": "66715-5571",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Daytime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms: minor aches and painsheadachesore throatnasal congestionfevercough due to minor throat and bronchial irritation."
},
{
"NDCCode": "66715-5572-8",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (66715-5572-8) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "66715-5572-08",
"ProductNDC": "66715-5572",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210616",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210616",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms: sore throatheadacheminor aches and painsfeverrunny nose and sneezingcough due to minor throat and bronchial irritation."
},
{
"NDCCode": "66715-5671-8",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (66715-5671-8) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "66715-5671-08",
"ProductNDC": "66715-5671",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Daytime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20140905",
"EndMarketingDate": "20240713",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200301",
"EndMarketingDatePackage": "20240713",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms: minor aches and painsheadachesore throatnasal congestionfevercough due to minor throat and bronchial irritation."
},
{
"NDCCode": "66715-5672-8",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (66715-5672-8) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "66715-5672-08",
"ProductNDC": "66715-5672",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20140905",
"EndMarketingDate": "20240810",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200301",
"EndMarketingDatePackage": "20240810",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms: sore throatheadacheminor aches and painsfeverrunny nose and sneezingcough due to minor throat and bronchial irritation."
},
{
"NDCCode": "66715-5744-8",
"PackageDescription": "8 POUCH in 1 CARTON (66715-5744-8) > 2 TABLET in 1 POUCH",
"NDC11Code": "66715-5744-08",
"ProductNDC": "66715-5744",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Multi-symptom Sinus Relief",
"NonProprietaryName": "Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151207",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181230",
"EndMarketingDatePackage": "20240426",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of: sinus congestion and pressurenasal congestionheadacheminor aches and pains. helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. temporarily relieves nasal congestion due to the common cold, hay fever and other upper respiratory allergies."
},
{
"NDCCode": "66715-5771-8",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (66715-5771-8) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "66715-5771-08",
"ProductNDC": "66715-5771",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Daytime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20140905",
"EndMarketingDate": "20240713",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200301",
"EndMarketingDatePackage": "20240713",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms: minor aches and painsheadachesore throatnasal congestionfevercough due to minor throat and bronchial irritation."
},
{
"NDCCode": "66715-5772-8",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (66715-5772-8) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "66715-5772-08",
"ProductNDC": "66715-5772",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20140905",
"EndMarketingDate": "20240810",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200301",
"EndMarketingDatePackage": "20240810",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms: sore throatheadacheminor aches and painsfeverrunny nose and sneezingcough due to minor throat and bronchial irritation."
},
{
"NDCCode": "66715-6314-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (66715-6314-8) / 12 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "66715-6314-08",
"ProductNDC": "66715-6314",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy 36ct, Caseys 4good",
"NonProprietaryName": "Diphenhydramine Hcl 25mg",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:, 2 runny nose, 3 itchy, watery eyes, 4 itching of the nose or throat, 5 sneezing, 6 temporarily relieves these symptoms due to the common cold:, 7 runny nose, 8 sneezing."
},
{
"NDCCode": "66715-6315-8",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (66715-6315-8) / 8 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "66715-6315-08",
"ProductNDC": "66715-6315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Cold And Flu Severe, Caseys 4good",
"NonProprietaryName": "Acetaminophen, Phenylephrine, Dextromethorphan Hbr, Guaifenesin Tablet, Film Coated",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230508",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN",
"StrengthNumber": "5; 10; 200; 325",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230508",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves common cold and flu symptoms:, 2 minor aches and pains, 3 sinus congestion and pressure, 4 sore throat, 5 fever, 6 headache, 7 nasal congestion, 8 cough due to minor throat and bronchial irritation, 9 reduces swelling of nasal passages, 10 temporarily restores freer breathing through the nose, 11 promotes nasal and/or sinus drainage, 12 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "66715-6402-8",
"PackageDescription": "30 POUCH in 1 BOX, UNIT-DOSE (66715-6402-8) / 1 TABLET in 1 POUCH",
"NDC11Code": "66715-6402-08",
"ProductNDC": "66715-6402",
"ProductTypeName": "HUMAN OTC DRUG",
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<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-9727-5</NDCCode>
<PackageDescription>84 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-5) </PackageDescription>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090162</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
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<LastUpdate>2024-08-10</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide.</Description>
</NDC>
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<NDCCode>71335-9727-6</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-6) </PackageDescription>
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<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-9727-7</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-7) </PackageDescription>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090162</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-9727-9</NDCCode>
<PackageDescription>45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-9) </PackageDescription>
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<ProductNDC>71335-9727</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090162</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>66715-5154-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (66715-5154-8) / 12 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-5154-08</NDC11Code>
<ProductNDC>66715-5154</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy, Circle K</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl 25mg Tablet</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210712</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. itchy, watery eyes. itching of the nose or throat. sneezing. temporarily relieves these symptoms due to the common cold:. runny nose. sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5254-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (66715-5254-8) > 12 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-5254-08</NDC11Code>
<ProductNDC>66715-5254</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy</ProprietaryName>
<ProprietaryNameSuffix>Circle K</ProprietaryNameSuffix>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150110</StartMarketingDate>
<EndMarketingDate>20241104</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200529</StartMarketingDatePackage>
<EndMarketingDatePackage>20241104</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nosesneezingitchy, watery eyesitching of the nose or throat. temporarily relieves these symptoms due to the common cold runny nosesneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5503-8</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (66715-5503-8) / 12 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>66715-5503</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep-aid, Circle K</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl Caplet, 25mg</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211220</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 for relief of occasional sleeplessness, 2 reduces time to fall asleep if you have difficulty falling asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5570-8</NDCCode>
<PackageDescription>251 mL in 1 BOTTLE, PLASTIC (66715-5570-8) </PackageDescription>
<NDC11Code>66715-5570-08</NDC11Code>
<ProductNDC>66715-5570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Blue Mint</ProprietaryName>
<NonProprietaryName>Eucalyptol, Menthol, Merthyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>LIL' DRUG STORE PRODUCTS, INC.</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.92; .42; .6; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps reduce plaque that leads to : 1 gingivitis, 2 bleeding gums.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5571-8</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (66715-5571-8) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-5571-08</NDC11Code>
<ProductNDC>66715-5571</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Daytime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
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<StartMarketingDate>20210825</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms: minor aches and painsheadachesore throatnasal congestionfevercough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5572-8</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (66715-5572-8) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-5572-08</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210616</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms: sore throatheadacheminor aches and painsfeverrunny nose and sneezingcough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5671-8</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (66715-5671-8) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-5671-08</NDC11Code>
<ProductNDC>66715-5671</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Daytime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20140905</StartMarketingDate>
<EndMarketingDate>20240713</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<EndMarketingDatePackage>20240713</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms: minor aches and painsheadachesore throatnasal congestionfevercough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5672-8</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (66715-5672-8) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-5672-08</NDC11Code>
<ProductNDC>66715-5672</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140905</StartMarketingDate>
<EndMarketingDate>20240810</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<EndMarketingDatePackage>20240810</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms: sore throatheadacheminor aches and painsfeverrunny nose and sneezingcough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5744-8</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (66715-5744-8) > 2 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>66715-5744-08</NDC11Code>
<ProductNDC>66715-5744</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Multi-symptom Sinus Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151207</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181230</StartMarketingDatePackage>
<EndMarketingDatePackage>20240426</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of: sinus congestion and pressurenasal congestionheadacheminor aches and pains. helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. temporarily relieves nasal congestion due to the common cold, hay fever and other upper respiratory allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5771-8</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (66715-5771-8) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-5771-08</NDC11Code>
<ProductNDC>66715-5771</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Daytime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140905</StartMarketingDate>
<EndMarketingDate>20240713</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<EndMarketingDatePackage>20240713</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms: minor aches and painsheadachesore throatnasal congestionfevercough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5772-8</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (66715-5772-8) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-5772-08</NDC11Code>
<ProductNDC>66715-5772</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140905</StartMarketingDate>
<EndMarketingDate>20240810</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<EndMarketingDatePackage>20240810</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms: sore throatheadacheminor aches and painsfeverrunny nose and sneezingcough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-6314-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (66715-6314-8) / 12 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-6314-08</NDC11Code>
<ProductNDC>66715-6314</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy 36ct, Caseys 4good</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl 25mg</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:, 2 runny nose, 3 itchy, watery eyes, 4 itching of the nose or throat, 5 sneezing, 6 temporarily relieves these symptoms due to the common cold:, 7 runny nose, 8 sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-6315-8</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (66715-6315-8) / 8 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-6315-08</NDC11Code>
<ProductNDC>66715-6315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Cold And Flu Severe, Caseys 4good</ProprietaryName>
<NonProprietaryName>Acetaminophen, Phenylephrine, Dextromethorphan Hbr, Guaifenesin Tablet, Film Coated</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 10; 200; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves common cold and flu symptoms:, 2 minor aches and pains, 3 sinus congestion and pressure, 4 sore throat, 5 fever, 6 headache, 7 nasal congestion, 8 cough due to minor throat and bronchial irritation, 9 reduces swelling of nasal passages, 10 temporarily restores freer breathing through the nose, 11 promotes nasal and/or sinus drainage, 12 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-6402-8</NDCCode>
<PackageDescription>30 POUCH in 1 BOX, UNIT-DOSE (66715-6402-8) / 1 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>66715-6402-08</NDC11Code>
<ProductNDC>66715-6402</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aleve</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020204</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: minor pain of arthritismuscular achesbackachemenstrual crampsheadachetoothachethe common cold. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-6403-8</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (66715-6403-8) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>66715-6403-08</NDC11Code>
<ProductNDC>66715-6403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Original Flavor</ProprietaryName>
<NonProprietaryName>Buffered Aspirin, Effervescent Tablet</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:, 2 headache, 3 muscle pain, 4 backache, 5 toothache, 6 menstrual pain, 7 colds, 8 minor pain of arthritis, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-6406-8</NDCCode>
<PackageDescription>30 POUCH in 1 BOX, UNIT-DOSE (66715-6406-8) / 2 TABLET, FILM COATED in 1 POUCH</PackageDescription>
<NDC11Code>66715-6406-08</NDC11Code>
<ProductNDC>66715-6406</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benadryl</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-6417-8</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (66715-6417-8) / 2 TABLET, FILM COATED in 1 POUCH</PackageDescription>
<NDC11Code>66715-6417-08</NDC11Code>
<ProductNDC>66715-6417</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol Pm Extra Strength, Cvp Health</ProprietaryName>
<NonProprietaryName>Acetaminophen And Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>25; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.</IndicationAndUsage>
</NDC>
</NDCList>