{
"NDC": [
{
"NDCCode": "66715-9823-9",
"PackageDescription": "5 POUCH in 1 CARTON (66715-9823-9) > 2 TABLET, CHEWABLE in 1 POUCH",
"NDC11Code": "66715-9823-09",
"ProductNDC": "66715-9823",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "7-select Pepto Bismol",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20110801",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "Lil' Drug Store Products, Inc",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "66715-9823-5",
"PackageDescription": "2 POUCH in 1 CARTON (66715-9823-5) > 2 TABLET, CHEWABLE in 1 POUCH",
"NDC11Code": "66715-9823-05",
"ProductNDC": "66715-9823",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "7-select Pepto Bismol",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20110801",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "Lil' Drug Store Products, Inc",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68788-9823-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (68788-9823-9) ",
"NDC11Code": "68788-9823-09",
"ProductNDC": "68788-9823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078402",
"LabelerName": "Preferred Pharmaceuticals, Inc",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120405",
"SamplePackage": "N"
},
{
"NDCCode": "66715-5544-9",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (66715-5544-9) / 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "66715-5544-09",
"ProductNDC": "66715-5544",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Non-drowsy Sinus Severe, Circle K",
"NonProprietaryName": "Acetaminophen, Guaifenesin, Phenylephrine Hcl Caplet, Film-coated",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"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], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:, 2 headache, 3 nasal congestion, 4 minor aches and pains, 5 sinus congestion and pressure, 6 helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive, 7 temporarily reduces fever."
},
{
"NDCCode": "66715-6744-9",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (66715-6744-9) / 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "66715-6744-09",
"ProductNDC": "66715-6744",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Sinus Severe",
"NonProprietaryName": "Acetaminophen, Guaifenesin, Phenylephrine Hcl Tablet, Film-coated",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220802",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "200; 5; 325",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220802",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:, 2 headache, 3 nasal congestion, 4 minor aches and pains, 5 sinus congestion and pressure, 6 helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive, 7 temporarily reduces fever."
},
{
"NDCCode": "66715-7021-9",
"PackageDescription": "1 KIT in 1 BAG (66715-7021-9) * .5 g in 1 POUCH (71927-034-01) ",
"NDC11Code": "66715-7021-09",
"ProductNDC": "66715-7021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Kit, Lil Drug Store",
"NonProprietaryName": "5 Adhesive Bandages, 2 Antibiotic Ointments",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Lil' Drug Store Products, Inc.",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "Use. First aid to help prevent infection in minor cuts, scrapes, and burns."
},
{
"NDCCode": "66715-9739-9",
"PackageDescription": "30 POUCH in 1 CARTON (66715-9739-9) > 2 TABLET in 1 POUCH",
"NDC11Code": "66715-9739-09",
"ProductNDC": "66715-9739",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lil Drug Store Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075010",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "66715-9747-9",
"PackageDescription": "30 POUCH in 1 BOX, UNIT-DOSE (66715-9747-9) / 2 TABLET, COATED in 1 POUCH",
"NDC11Code": "66715-9747-09",
"ProductNDC": "66715-9747",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110809",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220419",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: the common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "66715-9831-9",
"PackageDescription": "30 TABLET, EFFERVESCENT in 1 BOX, UNIT-DOSE (66715-9831-9) ",
"NDC11Code": "66715-9831-09",
"ProductNDC": "66715-9831",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Cold And Flu",
"NonProprietaryName": "Chlorpheniramine Maleate, Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide Tablet",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20220425",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "250; 10; 5; 2",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220517",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms due to a cold or flu:, 2 minor aches and pains, 3 headache, 4 cough, 5 sore throat, 6 runny nose, 7 sneezing, 8 nasal and sinus congestion, 9 temporarily reduces fever."
},
{
"NDCCode": "66715-9833-9",
"PackageDescription": "5 POUCH in 1 CARTON (66715-9833-9) > 2 TABLET, COATED in 1 POUCH",
"NDC11Code": "66715-9833-09",
"ProductNDC": "66715-9833",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "7-select Advil Pm",
"NonProprietaryName": "Ibuprofen And Diphenhydramine Citrate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021394",
"LabelerName": "Lil' Drug Store Products, Inc",
"SubstanceName": "IBUPROFEN; DIPHENHYDRAMINE CITRATE",
"StrengthNumber": "200; 38",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0404-9823-05",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 BAG (0404-9823-05) / 5 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "00404-9823-05",
"ProductNDC": "0404-9823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "ENDOTRACHEAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021146",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220109",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Injection is indicated for temporary blockade of severe or life-threatening muscariniceffects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinicmushroom poisoning, and to treat bradyasystolic cardiac arrest.",
"Description": "Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfatemonohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It isadministered parenterally by intravenous injection.Each milliliter (mL) contains 0.1 mg (adult strength) or 0.05 mg (pediatric strength) of atropine sulfatemonohydrate equivalent to 0.083 mg (adult strength) or 0.042 mg (pediatric strength) of atropine, andsodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment0.308 mOsmol/mL (calc.). pH 3.0 to 6.5.Sodium chloride added to render the solution isotonic for injection of the active ingredient is present inamounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride (Cl-) ions.The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) andis intended for use only as a single-dose injection. When smaller doses are required the unused portionshould be discarded.Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1)(salt) monohydrate, (C17H23NO3)2 H2SO4 H2O, colorless crystals or white crystalline powder verysoluble in water. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug.Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.The Ansyr® syringe is molded from a specially formulated polypropylene. Water permeates from insidethe container at an extremely slow rate which will have an insignificant effect on solution concentrationover the expected shelf life. Solutions in contact with the plastic container may leach out certain chemicalcomponents from the plastic in very small amounts; however, biological testing was supportive of thesafety of the syringe material."
},
{
"NDCCode": "66715-5206-0",
"PackageDescription": "15 POUCH in 1 BOX, UNIT-DOSE (66715-5206-0) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "66715-5206-00",
"ProductNDC": "66715-5206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer",
"NonProprietaryName": "Buffered Aspirin",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20230601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"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]",
"Status": "Active",
"LastUpdate": "2023-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"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."
},
{
"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": "66715-5628-3",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (66715-5628-3) / 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "66715-5628-03",
"ProductNDC": "66715-5628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Non-drowsy Max Cold",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hci Tablet, Film-coated",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10; 325; 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": "2023-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporary relieves these common cold and flu symptoms:, 2 minor aches and pains, 3 nasal congestion, 4 headache, 5 cough, 6 sinus congestion and pressure, 7 sore throat, 8 helps clear nasal passages, 9 promotes nasal and sinus drainage, 10 temporarily reduces fever."
},
{
"NDCCode": "66715-5635-4",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (66715-5635-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "66715-5635-04",
"ProductNDC": "66715-5635",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Reliever, 24/7 Life By 7-eleven",
"NonProprietaryName": "Acetaminophen Tablet, Film Coated",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220419",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"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 the common cold, 4 backach, 5 minor pain from arthritis, 6 toothache, 7 muscular aches, 8 premenstrual and menstrual cramps, 9 temporarily reduces fever."
},
{
"NDCCode": "66715-5646-4",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (66715-5646-4) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "66715-5646-04",
"ProductNDC": "66715-5646",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen, Solubilized",
"ProprietaryNameSuffix": "24/7 Life By 7-eleven",
"NonProprietaryName": "Ibuprofen Capsule, Liquid Filled",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20220419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078682",
"LabelerName": "Lil' Drug Store products, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220419",
"SamplePackage": "N",
"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."
},
{
"NDCCode": "66715-5680-4",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (66715-5680-4) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "66715-5680-04",
"ProductNDC": "66715-5680",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Pain Reliever",
"NonProprietaryName": "Acetaminophen 500 Mg, Film-coated Caplet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220509",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220509",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to:, 2 the common cold, 3 headache, 4 backache, 5 minor pain of arthritis, 6 toothache, 7 muscular aches, 8 premenstrual and menstrual cramps, 9 temporarily reduces fever."
},
{
"NDCCode": "66715-6304-3",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (66715-6304-3) / 6 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "66715-6304-03",
"ProductNDC": "66715-6304",
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]
}
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078402</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66715-5544-9</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (66715-5544-9) / 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-5544-09</NDC11Code>
<ProductNDC>66715-5544</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Non-drowsy Sinus Severe, Circle K</ProprietaryName>
<NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl Caplet, Film-coated</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</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], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:, 2 headache, 3 nasal congestion, 4 minor aches and pains, 5 sinus congestion and pressure, 6 helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive, 7 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-6744-9</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (66715-6744-9) / 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-6744-09</NDC11Code>
<ProductNDC>66715-6744</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Sinus Severe</ProprietaryName>
<NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl Tablet, Film-coated</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220802</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>200; 5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:, 2 headache, 3 nasal congestion, 4 minor aches and pains, 5 sinus congestion and pressure, 6 helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive, 7 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-7021-9</NDCCode>
<PackageDescription>1 KIT in 1 BAG (66715-7021-9) * .5 g in 1 POUCH (71927-034-01) </PackageDescription>
<NDC11Code>66715-7021-09</NDC11Code>
<ProductNDC>66715-7021</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Kit, Lil Drug Store</ProprietaryName>
<NonProprietaryName>5 Adhesive Bandages, 2 Antibiotic Ointments</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. First aid to help prevent infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-9739-9</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (66715-9739-9) > 2 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>66715-9739-09</NDC11Code>
<ProductNDC>66715-9739</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lil Drug Store Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075010</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>66715-9747-9</NDCCode>
<PackageDescription>30 POUCH in 1 BOX, UNIT-DOSE (66715-9747-9) / 2 TABLET, COATED in 1 POUCH</PackageDescription>
<NDC11Code>66715-9747-09</NDC11Code>
<ProductNDC>66715-9747</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol Extra Strength</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110809</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>2025-12-17</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: the common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-9831-9</NDCCode>
<PackageDescription>30 TABLET, EFFERVESCENT in 1 BOX, UNIT-DOSE (66715-9831-9) </PackageDescription>
<NDC11Code>66715-9831-09</NDC11Code>
<ProductNDC>66715-9831</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Cold And Flu</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate, Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide Tablet</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220425</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>250; 10; 5; 2</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves these symptoms due to a cold or flu:, 2 minor aches and pains, 3 headache, 4 cough, 5 sore throat, 6 runny nose, 7 sneezing, 8 nasal and sinus congestion, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-9833-9</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (66715-9833-9) > 2 TABLET, COATED in 1 POUCH</PackageDescription>
<NDC11Code>66715-9833-09</NDC11Code>
<ProductNDC>66715-9833</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>7-select Advil Pm</ProprietaryName>
<NonProprietaryName>Ibuprofen And Diphenhydramine Citrate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<EndMarketingDate>20171231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021394</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc</LabelerName>
<SubstanceName>IBUPROFEN; DIPHENHYDRAMINE CITRATE</SubstanceName>
<StrengthNumber>200; 38</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0404-9823-05</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 BAG (0404-9823-05) / 5 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>00404-9823-05</NDC11Code>
<ProductNDC>0404-9823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>ENDOTRACHEAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220109</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021146</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Injection is indicated for temporary blockade of severe or life-threatening muscariniceffects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinicmushroom poisoning, and to treat bradyasystolic cardiac arrest.</IndicationAndUsage>
<Description>Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfatemonohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It isadministered parenterally by intravenous injection.Each milliliter (mL) contains 0.1 mg (adult strength) or 0.05 mg (pediatric strength) of atropine sulfatemonohydrate equivalent to 0.083 mg (adult strength) or 0.042 mg (pediatric strength) of atropine, andsodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment0.308 mOsmol/mL (calc.). pH 3.0 to 6.5.Sodium chloride added to render the solution isotonic for injection of the active ingredient is present inamounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride (Cl-) ions.The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) andis intended for use only as a single-dose injection. When smaller doses are required the unused portionshould be discarded.Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1)(salt) monohydrate, (C17H23NO3)2 H2SO4 H2O, colorless crystals or white crystalline powder verysoluble in water. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug.Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.The Ansyr® syringe is molded from a specially formulated polypropylene. Water permeates from insidethe container at an extremely slow rate which will have an insignificant effect on solution concentrationover the expected shelf life. Solutions in contact with the plastic container may leach out certain chemicalcomponents from the plastic in very small amounts; however, biological testing was supportive of thesafety of the syringe material.</Description>
</NDC>
<NDC>
<NDCCode>66715-5206-0</NDCCode>
<PackageDescription>15 POUCH in 1 BOX, UNIT-DOSE (66715-5206-0) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>66715-5206-00</NDC11Code>
<ProductNDC>66715-5206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer</ProprietaryName>
<NonProprietaryName>Buffered Aspirin</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230601</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>20230601</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>66715-5428-4</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>66715-5628-3</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (66715-5628-3) / 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-5628-03</NDC11Code>
<ProductNDC>66715-5628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Non-drowsy Max Cold</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hci Tablet, Film-coated</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 325; 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>2023-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporary relieves these common cold and flu symptoms:, 2 minor aches and pains, 3 nasal congestion, 4 headache, 5 cough, 6 sinus congestion and pressure, 7 sore throat, 8 helps clear nasal passages, 9 promotes nasal and sinus drainage, 10 temporarily reduces fever.</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>66715-5646-4</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>
<NDC>
<NDCCode>66715-5680-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5680-4) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5680-04</NDC11Code>
<ProductNDC>66715-5680</ProductNDC>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
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<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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:, 2 the common cold, 3 headache, 4 backache, 5 minor pain of arthritis, 6 toothache, 7 muscular aches, 8 premenstrual and menstrual cramps, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>1 BLISTER PACK in 1 CARTON (66715-6304-3) / 6 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>66715-6304</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Cold And Flu Severe, Caseys 4goog</ProprietaryName>
<NonProprietaryName>Acetaminophen, Phenylephrine, Dextromethorphan Hbr, Guaifenesin Tablet, Film Coated</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
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<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>20230801</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>66715-6307-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-6307-4) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-6307-04</NDC11Code>
<ProductNDC>66715-6307</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen, Caseys 4good</ProprietaryName>
<NonProprietaryName>Ibuprofen Tablets</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<EndMarketingDate>20270401</EndMarketingDate>
<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>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<EndMarketingDatePackage>20270401</EndMarketingDatePackage>
<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, 6 backache, 7 the common cold, 8 menstrual cramps, 9 temporarily reduces fever.</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>66715-6321-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-6321-4) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-6321-04</NDC11Code>
<ProductNDC>66715-6321</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Pain Reliever, Caseys 4good</ProprietaryName>
<NonProprietaryName>Acetaminophen 500mg, Film-coated Caplet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230801</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>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:, 2 the common cold, 3 headache, 4 backache, 5 minor pain of arthritis, 6 toothache, 7 muscular aches, 8 premenstrual and menstrual cramps, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-6337-3</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (66715-6337-3) / 2 TABLET in 1 POUCH</PackageDescription>
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<ProductNDC>66715-6337</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Reliever, Caseys 4good</ProprietaryName>
<NonProprietaryName>Acetaminophen 500 Mg, Tablet</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230801</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>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:, 2 the common cold, 3 headache, 4 backache, 5 minor pain of arthritis, 6 toothache, 7 muscular aches, 8 premenstrual and menstrual cramps, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-6339-3</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (66715-6339-3) / 2 TABLET, FILM COATED in 1 POUCH</PackageDescription>
<NDC11Code>66715-6339-03</NDC11Code>
<ProductNDC>66715-6339</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen, Caseys 4good</ProprietaryName>
<NonProprietaryName>Ibuprofen Tablet, Film-coated</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075010</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>2023-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:, 2 headache, 3 toothache, 4 backache, 5 menstrual cramps, 6 the common cold, 7 muscular aches, 8 minor pain of arthritis, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-6403-2</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (66715-6403-2) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>66715-6403-02</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>20221128</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>66715-6403-7</NDCCode>
<PackageDescription>25 POUCH in 1 CARTON (66715-6403-7) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>66715-6403-07</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>66715-6403-8</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>66715-6404-2</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (66715-6404-2) / 2 TABLET, COATED in 1 POUCH</PackageDescription>
<NDC11Code>66715-6404-02</NDC11Code>
<ProductNDC>66715-6404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dayquil Severe Plus Vapocool Cold And Flu, Travel Basix</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221128</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</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>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion & pressure, 3 cough due to minor throat & bronchial irritation, 4 minor aches & pains, 5 headache, 6 fever, 7 sore throat, 8 reduces swelling of nasal passages, 9 temporarily restores freer breathing through the nose, 10 promotes nasal and/or sinus drainage, 11 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>66715-6405-2</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (66715-6405-2) / 2 TABLET, COATED in 1 POUCH</PackageDescription>
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<ProductNDC>66715-6405</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nyquil Severe Plus Vapocool Cold And Flu, Travel Basix</ProprietaryName>
<NonProprietaryName>Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>325; 5; 6.25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion & pressure, 3 cough due to minor throat & bronchial irritation, 4 cough to help you sleep, 5 minor aches & pains, 6 headache, 7 fever, 8 sore throat, 9 runny nose & sneezing, 10 reduces swelling of nasal passages, 11 temporarily restores freer breathing through the nose, 12 promotes nasal and/or sinus drainage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-6503-2</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (66715-6503-2) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
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<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>20220506</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>20220506</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>66715-6504-3</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (66715-6504-3) / 6 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-6504-03</NDC11Code>
<ProductNDC>66715-6504</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Severe, Cold And Flu, 24-7 Life By 7-eleven</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl Tablet, Film Coated Tablet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220506</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</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>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220506</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>
</NDCList>