{
"NDC": [
{
"NDCCode": "66715-5534-4",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (66715-5534-4) ",
"NDC11Code": "66715-5534-04",
"ProductNDC": "66715-5534",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210803",
"EndMarketingDate": "20280212",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"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": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210803",
"EndMarketingDatePackage": "20280212",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold/flu symptoms: minor aches and painsheadachesore throatrunny nose and sneezingfevercough due to minor throat and bronchial irritation."
},
{
"NDCCode": "54868-5534-4",
"PackageDescription": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-5534-4)",
"NDC11Code": "54868-5534-04",
"ProductNDC": "54868-5534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin Sodium",
"NonProprietaryName": "Phenytoin Sodium",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040684",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).",
"Description": "Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione, having the following structural formula. Each Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours."
},
{
"NDCCode": "0409-5534-14",
"PackageDescription": "10 CARTON in 1 PACKAGE (0409-5534-14) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE (0409-5534-24) ",
"NDC11Code": "00409-5534-14",
"ProductNDC": "0409-5534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202679",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "42",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200817",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis – e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial – e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.",
"Description": "Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. The solution is offered in a concentration of 4.2%. See table in HOW SUPPLIED section for contents and characteristics. The solution has an approximate pH of 8.0 (7.0 – 8.5). It contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium bicarbonate, 42 mg is equal to 0.5 milliequivalent each of Na+ and HCO3¯. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O."
},
{
"NDCCode": "50090-5534-0",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (50090-5534-0) / 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "50090-5534-00",
"ProductNDC": "50090-5534",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coricidin Hbp Cough And Cold",
"NonProprietaryName": "Chlorpheniramine Maleate, Dextromethorphan Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201023",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "30; 4",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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": "2024-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210504",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold, 2 temporarily relieves runny nose and sneezing due to the common cold."
},
{
"NDCCode": "54868-5534-0",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-5534-0)",
"NDC11Code": "54868-5534-00",
"ProductNDC": "54868-5534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin Sodium",
"NonProprietaryName": "Phenytoin Sodium",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040684",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).",
"Description": "Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione, having the following structural formula. Each Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours."
},
{
"NDCCode": "54868-5534-1",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-5534-1)",
"NDC11Code": "54868-5534-01",
"ProductNDC": "54868-5534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin Sodium",
"NonProprietaryName": "Phenytoin Sodium",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040684",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).",
"Description": "Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione, having the following structural formula. Each Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours."
},
{
"NDCCode": "54868-5534-2",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-5534-2)",
"NDC11Code": "54868-5534-02",
"ProductNDC": "54868-5534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin Sodium",
"NonProprietaryName": "Phenytoin Sodium",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040684",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).",
"Description": "Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione, having the following structural formula. Each Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours."
},
{
"NDCCode": "54868-5534-3",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-5534-3)",
"NDC11Code": "54868-5534-03",
"ProductNDC": "54868-5534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin Sodium",
"NonProprietaryName": "Phenytoin Sodium",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040684",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).",
"Description": "Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione, having the following structural formula. Each Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours."
},
{
"NDCCode": "55154-5534-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-5534-0) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "55154-5534-00",
"ProductNDC": "55154-5534",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA018659",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110520",
"SamplePackage": "N",
"IndicationAndUsage": "Allopurinol tablets are indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxalate rich foods, refined sugars and increases in oral fluids and fruits and vegetables).",
"Description": "Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1,5-Dihydro-4 H-pyrazolo[3,4- d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored, white, round tablet contains 100 mg or 300 mg allopurinol, USP and the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "66715-4644-4",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (66715-4644-4) / 6 TABLET in 1 BLISTER PACK",
"NDC11Code": "66715-4644-04",
"ProductNDC": "66715-4644",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-diarrheal, 24/7 Life By 7-eleven",
"NonProprietaryName": "Loperamide Hcl Tablet",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076497",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220914",
"SamplePackage": "N",
"IndicationAndUsage": "Use. controls symptoms of diarrhea, including Travelers’ Diarrhea."
},
{
"NDCCode": "66715-5428-4",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (66715-5428-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "66715-5428-04",
"ProductNDC": "66715-5428",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "24/7 Life By 7-eleven Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium Tablet, Film Coated",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204872",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220419",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to:, 2 headache, 3 muscular aches, 4 the common cold, 5 toothache, 6 menstrual cramps, 7 backache, 8 minor pain of arthritis, 9 temporarily reduces fever."
},
{
"NDCCode": "66715-5429-4",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (66715-5429-4) / 15 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "66715-5429-04",
"ProductNDC": "66715-5429",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Redness Reliever, Circle K",
"NonProprietaryName": "Tetrahydrozoline Hydrochloride Liquid",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20160226",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Lil' Drug Store products, Inc.",
"SubstanceName": "TETRAHYDROZOLINE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160226",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 relieves redness of the eye due to minor eye irritations."
},
{
"NDCCode": "66715-5460-4",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (66715-5460-4) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "66715-5460-04",
"ProductNDC": "66715-5460",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasal Spray, Circle K",
"NonProprietaryName": "Oxymetazoline Hydrochloride 0.05% Solution",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20251001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
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}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
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<ProductNDC>66715-5534</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210803</StartMarketingDate>
<EndMarketingDate>20280212</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>650; 30; 12.5</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</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>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210803</StartMarketingDatePackage>
<EndMarketingDatePackage>20280212</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold/flu symptoms: minor aches and painsheadachesore throatrunny nose and sneezingfevercough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54868-5534-4</NDCCode>
<PackageDescription>120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-5534-4)</PackageDescription>
<NDC11Code>54868-5534-04</NDC11Code>
<ProductNDC>54868-5534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin Sodium</ProprietaryName>
<NonProprietaryName>Phenytoin Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040684</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>PHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).</IndicationAndUsage>
<Description>Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione, having the following structural formula. Each Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours.</Description>
</NDC>
<NDC>
<NDCCode>0409-5534-14</NDCCode>
<PackageDescription>10 CARTON in 1 PACKAGE (0409-5534-14) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE (0409-5534-24) </PackageDescription>
<NDC11Code>00409-5534-14</NDC11Code>
<ProductNDC>0409-5534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202679</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>42</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis – e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial – e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.</IndicationAndUsage>
<Description>Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. The solution is offered in a concentration of 4.2%. See table in HOW SUPPLIED section for contents and characteristics. The solution has an approximate pH of 8.0 (7.0 – 8.5). It contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium bicarbonate, 42 mg is equal to 0.5 milliequivalent each of Na+ and HCO3¯. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O.</Description>
</NDC>
<NDC>
<NDCCode>50090-5534-0</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (50090-5534-0) / 8 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50090-5534-00</NDC11Code>
<ProductNDC>50090-5534</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coricidin Hbp Cough And Cold</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate, Dextromethorphan Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201023</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>30; 4</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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>2024-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold, 2 temporarily relieves runny nose and sneezing due to the common cold.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54868-5534-0</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-5534-0)</PackageDescription>
<NDC11Code>54868-5534-00</NDC11Code>
<ProductNDC>54868-5534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin Sodium</ProprietaryName>
<NonProprietaryName>Phenytoin Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040684</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>PHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).</IndicationAndUsage>
<Description>Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione, having the following structural formula. Each Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours.</Description>
</NDC>
<NDC>
<NDCCode>54868-5534-1</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-5534-1)</PackageDescription>
<NDC11Code>54868-5534-01</NDC11Code>
<ProductNDC>54868-5534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin Sodium</ProprietaryName>
<NonProprietaryName>Phenytoin Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040684</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>PHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).</IndicationAndUsage>
<Description>Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione, having the following structural formula. Each Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours.</Description>
</NDC>
<NDC>
<NDCCode>54868-5534-2</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-5534-2)</PackageDescription>
<NDC11Code>54868-5534-02</NDC11Code>
<ProductNDC>54868-5534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin Sodium</ProprietaryName>
<NonProprietaryName>Phenytoin Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040684</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>PHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).</IndicationAndUsage>
<Description>Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione, having the following structural formula. Each Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours.</Description>
</NDC>
<NDC>
<NDCCode>54868-5534-3</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-5534-3)</PackageDescription>
<NDC11Code>54868-5534-03</NDC11Code>
<ProductNDC>54868-5534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin Sodium</ProprietaryName>
<NonProprietaryName>Phenytoin Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040684</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>PHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).</IndicationAndUsage>
<Description>Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione, having the following structural formula. Each Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours.</Description>
</NDC>
<NDC>
<NDCCode>55154-5534-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-5534-0) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-5534-00</NDC11Code>
<ProductNDC>55154-5534</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA018659</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allopurinol tablets are indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxalate rich foods, refined sugars and increases in oral fluids and fruits and vegetables).</IndicationAndUsage>
<Description>Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1,5-Dihydro-4 H-pyrazolo[3,4- d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored, white, round tablet contains 100 mg or 300 mg allopurinol, USP and the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>66715-4644-4</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (66715-4644-4) / 6 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-4644-04</NDC11Code>
<ProductNDC>66715-4644</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-diarrheal, 24/7 Life By 7-eleven</ProprietaryName>
<NonProprietaryName>Loperamide Hcl Tablet</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076497</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. controls symptoms of diarrhea, including Travelers’ Diarrhea.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5428-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5428-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5428-04</NDC11Code>
<ProductNDC>66715-5428</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>24/7 Life By 7-eleven Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium Tablet, Film Coated</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204872</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>2025-11-28</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 muscular aches, 4 the common cold, 5 toothache, 6 menstrual cramps, 7 backache, 8 minor pain of arthritis, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5429-4</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (66715-5429-4) / 15 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>66715-5429-04</NDC11Code>
<ProductNDC>66715-5429</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Redness Reliever, Circle K</ProprietaryName>
<NonProprietaryName>Tetrahydrozoline Hydrochloride Liquid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20160226</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Lil' Drug Store products, Inc.</LabelerName>
<SubstanceName>TETRAHYDROZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 relieves redness of the eye due to minor eye irritations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5460-4</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (66715-5460-4) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>66715-5460-04</NDC11Code>
<ProductNDC>66715-5460</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasal Spray, Circle K</ProprietaryName>
<NonProprietaryName>Oxymetazoline Hydrochloride 0.05% Solution</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20251001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves nasal congestion due to:, 2 common cold, 3 hay fever, 4 upper respiratory allergies, 5 temporarily relieves sinus congestion and pressure, 6 shrinks swollen nasal membranes so you can breathe more freely.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5504-4</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (66715-5504-4) </PackageDescription>
<NDC11Code>66715-5504-04</NDC11Code>
<ProductNDC>66715-5504</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Aspirin 325</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211110</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>2023-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 headache, 2 muscle pain, 3 toothache, 4 menstrual pain, 5 pain and fever of colds, 6 minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5506-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5506-4) / 50 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5506-04</NDC11Code>
<ProductNDC>66715-5506</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Headache, Circle K</ProprietaryName>
<NonProprietaryName>Acetaminophen/aspirin/caffeine Tablet</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210924</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ASPIRIN; CAFFEINE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>250; 65; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:, 2 headache, 3 a cold, 4 arthritis, 5 muscular aches, 6 sinusitis, 7 toothache, 8 premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5507-4</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (66715-5507-4) > 50 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>66715-5507-04</NDC11Code>
<ProductNDC>66715-5507</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079174</ApplicationNumber>
<LabelerName>Lil Drug Store Products, Inc</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>Active</Status>
<LastUpdate>2022-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachetoothachebackachemenstrual crampsthe common coldmuscular achesminor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5508-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5508-4) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5508-04</NDC11Code>
<ProductNDC>66715-5508</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Pain Reliever</ProprietaryName>
<NonProprietaryName>Acetaminophen Caplets, 500 Mg</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210907</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210907</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains. due to:. the common cold. headache. backache. minor pain of arthritis. toothache. muscular aches. premenstrual and menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5526-4</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (66715-5526-4) / 30 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>66715-5526-04</NDC11Code>
<ProductNDC>66715-5526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasal Spray, 1oz, 24/7 Life By 7-eleven</ProprietaryName>
<NonProprietaryName>Oxymetazoline Hcl Nasal Solution 0.05%</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20251001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves nasal congestion due to:, 2 common cold, 3 hay fever, 4 upper respiratory allergies, 5 temporarily relieves sinus congestion and pressure, 6 shrinks swollen nasal membranes so you can breathe more freely.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5531-4</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (66715-5531-4) </PackageDescription>
<NDC11Code>66715-5531-04</NDC11Code>
<ProductNDC>66715-5531</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Daytime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210807</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/15mL; mg/15mL; mg/15mL</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>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms minor aches and painsheadachesore throatnasal congestionfeversinus pressurecough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5555-4</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (66715-5555-4) </PackageDescription>
<NDC11Code>66715-5555-04</NDC11Code>
<ProductNDC>66715-5555</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stomach</ProprietaryName>
<ProprietaryNameSuffix>Circle K</ProprietaryNameSuffix>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>525</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Bismuth [CS], Bismuth [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 diarrhea, 2 travelers' diarrhea, 3 upset stomach due to overindulgence in food and drink, including heartburngasindigestionnauseafullnessbelching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5560-4</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (66715-5560-4) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>66715-5560-04</NDC11Code>
<ProductNDC>66715-5560</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K</ProprietaryName>
<ProprietaryNameSuffix>Congestion Relief</ProprietaryNameSuffix>
<NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20210624</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves nasal congestion due to: common coldhay feverupper respiratory allergies. Shrinks swollen nasal membranes so you can breathe more freely.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5607-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5607-4) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5607-04</NDC11Code>
<ProductNDC>66715-5607</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen, Circle K, 50ct</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079129</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</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>Active</Status>
<LastUpdate>2024-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:, 2 headache, 3 muscular aches, 4 minor pain of arthritis, 5 toothache backache, 6 the common cold, 7 menstrual cramps, 8 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5626-4</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (66715-5626-4) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>66715-5626-04</NDC11Code>
<ProductNDC>66715-5626</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasal Spray, 24-7 For Life</ProprietaryName>
<NonProprietaryName>Oxymetazoline Hydrochloride 0.05%</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves nasal congestion due to:, 2 common cold, 3 hay fever, 4 upper respiratory allergies, 5 temporarily relieves sinus congestion and pressure, 6 shrinks swollen nasal membranes so you can breathe more freely.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5635-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5635-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5635-04</NDC11Code>
<ProductNDC>66715-5635</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Reliever, 24/7 Life By 7-eleven</ProprietaryName>
<NonProprietaryName>Acetaminophen Tablet, Film Coated</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>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-28</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 the common cold, 4 backach, 5 minor pain from arthritis, 6 toothache, 7 muscular aches, 8 premenstrual and menstrual cramps, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5637-4</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (66715-5637-4) > 24 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>66715-5637-04</NDC11Code>
<ProductNDC>66715-5637</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Pain Reliever</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141101</StartMarketingDate>
<EndMarketingDate>20221017</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160804</StartMarketingDatePackage>
<EndMarketingDatePackage>20221017</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66715-5640-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5640-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5640-04</NDC11Code>
<ProductNDC>66715-5640</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Reliever Pm, Extra Strength, 24-7 Life By 7-eleven</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hcl Tablet, Film Coated</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>Uses. temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5641-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5641-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5641-04</NDC11Code>
<ProductNDC>66715-5641</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Headache Relief, Extra Strength</ProprietaryName>
<ProprietaryNameSuffix>24/7 Life By 7-eleven</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin, Caffeine Tablet, Film Coated</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>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</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>Uses. temporarily relieves minor aches and pains due to: 1 a cold, 2 toothache, 3 arthritis, 4 muscular aches, 5 headache, 6 premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5642-4</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (66715-5642-4) / 16 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-5642-04</NDC11Code>
<ProductNDC>66715-5642</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Sleep Aid, 24-7 Life By 7-eleven</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate Tablet</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</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>Use: 1 helps to reduce difficulty in falling asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5644-4</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (66715-5644-4) / 2 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>66715-5644-04</NDC11Code>
<ProductNDC>66715-5644</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-diarrheal 24/7 For Life By 7-eleven</ProprietaryName>
<NonProprietaryName>Loperamide Hcl Tablet</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076497</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. controls symptoms of diarrhea, including Travelers’ Diarrhea.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5646-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5646-4) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5646-04</NDC11Code>
<ProductNDC>66715-5646</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen, Solubilized</ProprietaryName>
<ProprietaryNameSuffix>24/7 Life By 7-eleven</ProprietaryNameSuffix>
<NonProprietaryName>Ibuprofen Capsule, Liquid Filled</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078682</ApplicationNumber>
<LabelerName>Lil' Drug Store products, Inc.</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>Active</Status>
<LastUpdate>2025-12-06</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 minor pain of arthritis, 3 headache, 4 the common cold, 5 backache, 6 menstrual cramps, 7 toothache, 8 muscular aches, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
</NDCList>