{
"NDC": [
{
"NDCCode": "69729-223-06",
"PackageDescription": "3 POUCH in 1 CARTON (69729-223-06) / 2 TABLET in 1 POUCH",
"NDC11Code": "69729-0223-06",
"ProductNDC": "69729-223",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pentrexcilina Daytime",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201230",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN",
"StrengthNumber": "10; 4; 500",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240110",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms of hay fever or other respiratory allergies:, 2 headache, 3 sinus congestion & pressure, 4 nasal congestion, 5 runny nose and sneezing, 6 minor aches & pain, 7 temporarily relieves these additional symptoms of hay fever:, 8 nose or throat itching, 9 itchy, watery eyes, 10 helps clear nasal passages, 11 helps decongest sinus opening and passages."
},
{
"NDCCode": "69729-223-02",
"PackageDescription": "2 TABLET in 1 POUCH (69729-223-02) ",
"NDC11Code": "69729-0223-02",
"ProductNDC": "69729-223",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pentrexcilina Daytime",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201230",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN",
"StrengthNumber": "10; 4; 500",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201230",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms of hay fever or other respiratory allergies:, 2 headache, 3 sinus congestion & pressure, 4 nasal congestion, 5 runny nose and sneezing, 6 minor aches & pain, 7 temporarily relieves these additional symptoms of hay fever:, 8 nose or throat itching, 9 itchy, watery eyes, 10 helps clear nasal passages, 11 helps decongest sinus opening and passages."
},
{
"NDCCode": "69729-223-37",
"PackageDescription": "6 POUCH in 1 CARTON (69729-223-37) / 2 TABLET in 1 POUCH",
"NDC11Code": "69729-0223-37",
"ProductNDC": "69729-223",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pentrexcilina Daytime",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201230",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN",
"StrengthNumber": "10; 4; 500",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240110",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms of hay fever or other respiratory allergies:, 2 headache, 3 sinus congestion & pressure, 4 nasal congestion, 5 runny nose and sneezing, 6 minor aches & pain, 7 temporarily relieves these additional symptoms of hay fever:, 8 nose or throat itching, 9 itchy, watery eyes, 10 helps clear nasal passages, 11 helps decongest sinus opening and passages."
},
{
"NDCCode": "69729-223-38",
"PackageDescription": "72 POUCH in 1 CARTON (69729-223-38) / 2 TABLET in 1 POUCH",
"NDC11Code": "69729-0223-38",
"ProductNDC": "69729-223",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pentrexcilina Daytime",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201230",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN",
"StrengthNumber": "10; 4; 500",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201230",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms of hay fever or other respiratory allergies:, 2 headache, 3 sinus congestion & pressure, 4 nasal congestion, 5 runny nose and sneezing, 6 minor aches & pain, 7 temporarily relieves these additional symptoms of hay fever:, 8 nose or throat itching, 9 itchy, watery eyes, 10 helps clear nasal passages, 11 helps decongest sinus opening and passages."
},
{
"NDCCode": "69729-223-50",
"PackageDescription": "50 POUCH in 1 CARTON (69729-223-50) / 2 TABLET in 1 POUCH",
"NDC11Code": "69729-0223-50",
"ProductNDC": "69729-223",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pentrexcilina Daytime",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201230",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN",
"StrengthNumber": "10; 4; 500",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201230",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms of hay fever or other respiratory allergies:, 2 headache, 3 sinus congestion & pressure, 4 nasal congestion, 5 runny nose and sneezing, 6 minor aches & pain, 7 temporarily relieves these additional symptoms of hay fever:, 8 nose or throat itching, 9 itchy, watery eyes, 10 helps clear nasal passages, 11 helps decongest sinus opening and passages."
},
{
"NDCCode": "49483-223-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (49483-223-06) ",
"NDC11Code": "49483-0223-06",
"ProductNDC": "49483-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitro-time",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140619",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181009",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. Molecular Formula: C3H5N3O9. Molecular Weight: 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin. The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose. monohydrate, propylene glycol, shellac, sugar, talc, and wax. Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide."
},
{
"NDCCode": "64220-223-06",
"PackageDescription": "15 kg in 1 DRUM (64220-223-06) ",
"NDC11Code": "64220-0223-06",
"ProductNDC": "64220-223",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Agomelatine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240730",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "AGOMELATINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-08-01",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "30-JUL-24"
},
{
"NDCCode": "67777-223-06",
"PackageDescription": "12 JAR in 1 CASE (67777-223-06) / 425 g in 1 JAR (67777-223-05) ",
"NDC11Code": "67777-0223-06",
"ProductNDC": "67777-223",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zinc Oxide",
"NonProprietaryName": "Zinc Oxide Ointment",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240229",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Dynarex Corporation",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240229",
"SamplePackage": "N",
"IndicationAndUsage": " Helps treat chafed skin associated with diaper rash. Dries the oozing and weeping of poison ivy, oak, and sumac."
},
{
"NDCCode": "68382-223-06",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68382-223-06) ",
"NDC11Code": "68382-0223-06",
"ProductNDC": "68382-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079017",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170612",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Each atomoxetine capsule intended for oral administration contains atomoxetine hydrochloride, USP equivalent to atomoxetine 10 mg or 18 mg or 25 mg or 40 mg or 60 mg or 80 mg or 100 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, pregelatinized starch, sodium lauryl sulfate and titanium dioxide. Additionally each 18 mg capsule shell contains: iron oxide yellow, each 25 mg and 40 mg capsule shell contains: FD & C blue # 2, each 60 mg capsule shell contains: FD & C blue # 2 and iron oxide yellow and each 80 mg and 100 mg capsule shell contains: iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "68428-223-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-223-06) ",
"NDC11Code": "68428-0223-06",
"ProductNDC": "68428-223",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Montana",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090828",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090828",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. ARNICA Bruises."
},
{
"NDCCode": "71921-223-06",
"PackageDescription": "60 TABLET in 1 BOTTLE (71921-223-06) ",
"NDC11Code": "71921-0223-06",
"ProductNDC": "71921-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208308",
"LabelerName": "Florida Pharmaceutical Products, LLC",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230921",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide tablets are indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older (1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).",
"Description": "The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "69729-051-06",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69729-051-06) / 177 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "69729-0051-06",
"ProductNDC": "69729-051",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tenalif Multi Symptom Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20230918",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "500; 10; 26.66; 400",
"StrengthUnit": "mg/20mL; mg/20mL; mg/20mL; mg/20mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230918",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold/flu symptoms: 1 sinus congestion & pressure, 2 minor aches & pains, 3 nasal congestion, 4 cough due to minor throat & bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promotes nasal and/or sinus drainage, 9 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "69729-070-06",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69729-070-06) / 177 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "69729-0070-06",
"ProductNDC": "69729-070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tenalif Children",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20230918",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "250; 5; 13.33; 200",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230918",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold/flu symptoms: 1 sinus congestion & pressure, 2 minor aches & pains, 3 nasal congestion, 4 cough due to minor throat & bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promotes nasal and/or sinus drainage, 9 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "69729-122-06",
"PackageDescription": "3 PACKET in 1 CARTON (69729-122-06) / 2 TABLET in 1 PACKET",
"NDC11Code": "69729-0122-06",
"ProductNDC": "69729-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190826",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "500; 4; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230904",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other respiratory allergies: 1 headache, 2 nasal congestion, 3 sinus congestion & pressure, 4 runny nose and sneezing, 5 minor aches & pain."
},
{
"NDCCode": "69729-132-06",
"PackageDescription": "3 PACKET in 1 CARTON (69729-132-06) / 2 TABLET, COATED in 1 PACKET",
"NDC11Code": "69729-0132-06",
"ProductNDC": "69729-132",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Buscapina",
"NonProprietaryName": "Acetaminophen, Caffeine, Pyrilamine Maleate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230904",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "OPMX LLC",
"SubstanceName": "PYRILAMINE MALEATE; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "15; 500; 60",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230904",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of these symptoms associated with menstrual periods: 1 cramps, 2 bloating, 3 water-weight gain, 4 headache, 5 backache, 6 muscle aches, 7 fatigue."
},
{
"NDCCode": "69729-133-06",
"PackageDescription": "3 POUCH in 1 CARTON (69729-133-06) / 2 TABLET in 1 POUCH",
"NDC11Code": "69729-0133-06",
"ProductNDC": "69729-133",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coldtac Ultra",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240110",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
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"LabelerName": "OPMX LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "10; 500; 4",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240110",
"SamplePackage": "N"
},
{
"NDCCode": "69729-142-06",
"PackageDescription": "3 POUCH in 1 PACKAGE (69729-142-06) > 2 TABLET in 1 POUCH",
"NDC11Code": "69729-0142-06",
"ProductNDC": "69729-142",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coldtac Ultra",
"NonProprietaryName": "Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine Hcl 5mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180105",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "OPMX LLC",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 2; 5",
"StrengthUnit": "mg/1; mg/1; 1/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180105",
"SamplePackage": "N",
"IndicationAndUsage": "Tempporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 headache, 2 sinus congestion and pressure, 3 nasal congestion, 4 runny nose and sneezing, 5 minor aches and pains."
},
{
"NDCCode": "69729-143-06",
"PackageDescription": "6 POUCH in 1 PACKAGE (69729-143-06) / 2 TABLET in 1 POUCH",
"NDC11Code": "69729-0143-06",
"ProductNDC": "69729-143",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coldtac Plus",
"NonProprietaryName": "Acetaminophen, Phenylephrin Hydrochloride, Dextromethorphan Hydrobromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180105",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "325; 5; 15; 200",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180105",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily: 1 Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, 2 Relieves sinus congestion and pressure, helps decongest sinus openings and passages, 3 Restores freer breathing, 4 Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive, 5 Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants, 6 Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps."
},
{
"NDCCode": "69729-155-06",
"PackageDescription": "6 POUCH in 1 PACKAGE (69729-155-06) > 2 TABLET in 1 POUCH",
"NDC11Code": "69729-0155-06",
"ProductNDC": "69729-155",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pentrexcilina",
"NonProprietaryName": "Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180105",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "OPMX LLC",
"SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "325; 5; 15",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180105",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily: 1 Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, 2 Relieves sinus congestion and pressure, helps decongest sinus openings and passages, 3 Restores freer breathing, 4 Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive, 5 Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants, 6 Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps."
},
{
"NDCCode": "69729-222-06",
"PackageDescription": "3 POUCH in 1 CARTON (69729-222-06) / 2 TABLET in 1 POUCH",
"NDC11Code": "69729-0222-06",
"ProductNDC": "69729-222",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190826",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "OPMX LLC",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "500; 4; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230904",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms of hay fever or other respiratory allergies: 1 Headache, 2 Nasal congestion, 3 Sinus congestion & pressure, 4 Runny nose and sneezing, 5 Minor aches & pain."
},
{
"NDCCode": "69729-620-06",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (69729-620-06) > 177 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "69729-0620-06",
"ProductNDC": "69729-620",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Twkof Children",
"NonProprietaryName": "Pain Reliever/fever Reducer, Cough Suppresant, Expectorant, Nasal Decongestant",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20220422",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "OPMX LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220422",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms. : 1 nasal decongestion, 2 cough, 3 minor aches and pains, 4 sorethroat, 5 headache, 6 temporarily reduces fever, 7 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "69729-621-06",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (69729-621-06) > 177 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "69729-0621-06",
"ProductNDC": "69729-621",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Twkof Adult",
"NonProprietaryName": "Pain Reliever/fever Reducer, Cough Suppresant, Expectorant, Nasal Decongestant",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20220422",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "OPMX LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 400; 10",
"StrengthUnit": "mg/20mL; mg/20mL; mg/20mL; mg/20mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220422",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms: 1 sinus congestion and pressure, 2 minor aches and pains."
},
{
"NDCCode": "69729-784-06",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69729-784-06) / 177 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "69729-0784-06",
"ProductNDC": "69729-784",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rompe Tos X Children",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20230918",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "250; 5; 13.33; 200",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230918",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold/flu symptoms: 1 sinus congestion & pressure, 2 minor aches & pains, 3 nasal congestion, 4 cough due to minor throat & bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promotes nasal and/or sinus drainage, 9 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "69729-785-06",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69729-785-06) / 177 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "69729-0785-06",
"ProductNDC": "69729-785",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rompe Tos X Adults",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20230918",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "500; 10; 26.66; 400",
"StrengthUnit": "mg/20mL; mg/20mL; mg/20mL; mg/20mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230918",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold/flu symptoms: 1 sinus congestion & pressure, 2 minor aches & pains, 3 nasal congestion, 4 cough due to minor throat & bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promotes nasal and/or sinus drainage, 9 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "69729-786-06",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69729-786-06) / 177 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "69729-0786-06",
"ProductNDC": "69729-786",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tesalon Children",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guafeisin Usp, Phenylephrine Hcl",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "200; 13.33; 5; 250",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240927",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. temporarily relieves these common cold and flu symptoms: 1 sinus congestion and pressure, 2 minor aches and pains, 3 nasal congestion, 4 cough due to minor throat and bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promotes nasal and/or sinus drainage, 9 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "69729-787-06",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69729-787-06) / 177 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "69729-0787-06",
"ProductNDC": "69729-787",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tesalon Jarabe Adulto",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin Usp, Phenylephrine Hcl",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20240927",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN",
"StrengthNumber": "500; 26.66; 10; 400",
"StrengthUnit": "mg/20mL; mg/20mL; mg/20mL; mg/20mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240927",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms. sinus congestion and pressure minor aches and pains nasal congestion cough due to minor throat and bronchial irritation sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "69729-789-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (69729-789-06) / 177 mL in 1 BOTTLE",
"NDC11Code": "69729-0789-06",
"ProductNDC": "69729-789",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pentrexcilina Children Total Relief Multi-symptom",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin Usp, Phenylephrine Hydrochloride",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20250115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "5; 250; 13.33; 200",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250115",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms: 1 sinus congestion and pressure, 2 minor aches and pains, 3 nasal congestion, 4 cough due to minor throat and bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promtoes nasal and/or sinus drainage, 9 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "69729-790-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (69729-790-06) / 177 mL in 1 BOTTLE",
"NDC11Code": "69729-0790-06",
"ProductNDC": "69729-790",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pentrexcilina Adult Total Relief Multi-symptom",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin Usp, Phenylephrine Hydrochloride",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20250115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "10; 500; 26.66; 400",
"StrengthUnit": "mg/20mL; mg/20mL; mg/20mL; mg/20mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250115",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms: 1 sinus congestion and pressure, 2 minor aches and pains, 3 nasal congestion, 4 cough due to minor throat and bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promotes nasal and/or sinus drainage, 9 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "69729-056-10",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (69729-056-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "69729-0056-10",
"ProductNDC": "69729-056",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viro-flu Am Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20260130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "OPMX LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "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": "2026-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260130",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily reliever common cold/flu symptoms: 1 Cough due to minor throat & bronchial irritation, 2 Sore throat, 3 Headache, 4 Minor aches and pains, 5 Fever."
},
{
"NDCCode": "69729-122-37",
"PackageDescription": "12 TABLET in 1 POUCH (69729-122-37) ",
"NDC11Code": "69729-0122-37",
"ProductNDC": "69729-122",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
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}
]
}
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<ProductNDC>49483-223</ProductNDC>
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<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140619</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
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<PackageDescription>15 kg in 1 DRUM (64220-223-06) </PackageDescription>
<NDC11Code>64220-0223-06</NDC11Code>
<ProductNDC>64220-223</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Agomelatine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240730</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
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<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-08-01</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-JUL-24</StartMarketingDatePackage>
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<NDCCode>67777-223-06</NDCCode>
<PackageDescription>12 JAR in 1 CASE (67777-223-06) / 425 g in 1 JAR (67777-223-05) </PackageDescription>
<NDC11Code>67777-0223-06</NDC11Code>
<ProductNDC>67777-223</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zinc Oxide</ProprietaryName>
<NonProprietaryName>Zinc Oxide Ointment</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240229</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Dynarex Corporation</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps treat chafed skin associated with diaper rash. Dries the oozing and weeping of poison ivy, oak, and sumac.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>30 CAPSULE in 1 BOTTLE (68382-223-06) </PackageDescription>
<NDC11Code>68382-0223-06</NDC11Code>
<ProductNDC>68382-223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079017</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
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</NDC>
<NDC>
<NDCCode>68428-223-06</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (68428-223-06) </PackageDescription>
<NDC11Code>68428-0223-06</NDC11Code>
<ProductNDC>68428-223</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica Montana</ProprietaryName>
<NonProprietaryName>Arnica Montana</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090828</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. ARNICA Bruises.</IndicationAndUsage>
</NDC>
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<PackageDescription>60 TABLET in 1 BOTTLE (71921-223-06) </PackageDescription>
<NDC11Code>71921-0223-06</NDC11Code>
<ProductNDC>71921-223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208308</ApplicationNumber>
<LabelerName>Florida Pharmaceutical Products, LLC</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide tablets are indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older (1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).</IndicationAndUsage>
<Description>The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>69729-051-06</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69729-051-06) / 177 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69729-0051-06</NDC11Code>
<ProductNDC>69729-051</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tenalif Multi Symptom Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230918</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
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<StrengthUnit>mg/20mL; mg/20mL; mg/20mL; mg/20mL</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>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold/flu symptoms: 1 sinus congestion & pressure, 2 minor aches & pains, 3 nasal congestion, 4 cough due to minor throat & bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promotes nasal and/or sinus drainage, 9 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69729-070-06) / 177 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69729-0070-06</NDC11Code>
<ProductNDC>69729-070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tenalif Children</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>250; 5; 13.33; 200</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL; mg/10mL</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>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold/flu symptoms: 1 sinus congestion & pressure, 2 minor aches & pains, 3 nasal congestion, 4 cough due to minor throat & bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promotes nasal and/or sinus drainage, 9 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>69729-122-06</NDCCode>
<PackageDescription>3 PACKET in 1 CARTON (69729-122-06) / 2 TABLET in 1 PACKET</PackageDescription>
<NDC11Code>69729-0122-06</NDC11Code>
<ProductNDC>69729-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</ProprietaryName>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 4; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other respiratory allergies: 1 headache, 2 nasal congestion, 3 sinus congestion & pressure, 4 runny nose and sneezing, 5 minor aches & pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69729-132-06</NDCCode>
<PackageDescription>3 PACKET in 1 CARTON (69729-132-06) / 2 TABLET, COATED in 1 PACKET</PackageDescription>
<NDC11Code>69729-0132-06</NDC11Code>
<ProductNDC>69729-132</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Buscapina</ProprietaryName>
<NonProprietaryName>Acetaminophen, Caffeine, Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230904</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>PYRILAMINE MALEATE; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>15; 500; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of these symptoms associated with menstrual periods: 1 cramps, 2 bloating, 3 water-weight gain, 4 headache, 5 backache, 6 muscle aches, 7 fatigue.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69729-133-06</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (69729-133-06) / 2 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>69729-0133-06</NDC11Code>
<ProductNDC>69729-133</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coldtac Ultra</ProprietaryName>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240110</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>10; 500; 4</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69729-142-06</NDCCode>
<PackageDescription>3 POUCH in 1 PACKAGE (69729-142-06) > 2 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>69729-0142-06</NDC11Code>
<ProductNDC>69729-142</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coldtac Ultra</ProprietaryName>
<NonProprietaryName>Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine Hcl 5mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 2; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; 1/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tempporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 headache, 2 sinus congestion and pressure, 3 nasal congestion, 4 runny nose and sneezing, 5 minor aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69729-143-06</NDCCode>
<PackageDescription>6 POUCH in 1 PACKAGE (69729-143-06) / 2 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>69729-0143-06</NDC11Code>
<ProductNDC>69729-143</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coldtac Plus</ProprietaryName>
<NonProprietaryName>Acetaminophen, Phenylephrin Hydrochloride, Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>325; 5; 15; 200</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>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily: 1 Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, 2 Relieves sinus congestion and pressure, helps decongest sinus openings and passages, 3 Restores freer breathing, 4 Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive, 5 Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants, 6 Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69729-155-06</NDCCode>
<PackageDescription>6 POUCH in 1 PACKAGE (69729-155-06) > 2 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>69729-0155-06</NDC11Code>
<ProductNDC>69729-155</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pentrexcilina</ProprietaryName>
<NonProprietaryName>Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>325; 5; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily: 1 Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, 2 Relieves sinus congestion and pressure, helps decongest sinus openings and passages, 3 Restores freer breathing, 4 Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive, 5 Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants, 6 Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69729-222-06</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (69729-222-06) / 2 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>69729-0222-06</NDC11Code>
<ProductNDC>69729-222</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</ProprietaryName>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 4; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other respiratory allergies: 1 Headache, 2 Nasal congestion, 3 Sinus congestion & pressure, 4 Runny nose and sneezing, 5 Minor aches & pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69729-620-06</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (69729-620-06) > 177 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>69729-0620-06</NDC11Code>
<ProductNDC>69729-620</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Twkof Children</ProprietaryName>
<NonProprietaryName>Pain Reliever/fever Reducer, Cough Suppresant, Expectorant, Nasal Decongestant</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220422</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL; mg/10mL</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>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms. : 1 nasal decongestion, 2 cough, 3 minor aches and pains, 4 sorethroat, 5 headache, 6 temporarily reduces fever, 7 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>69729-621-06</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (69729-621-06) > 177 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>69729-0621-06</NDC11Code>
<ProductNDC>69729-621</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Twkof Adult</ProprietaryName>
<NonProprietaryName>Pain Reliever/fever Reducer, Cough Suppresant, Expectorant, Nasal Decongestant</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220422</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 400; 10</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL; mg/20mL; mg/20mL</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>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms: 1 sinus congestion and pressure, 2 minor aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69729-784-06</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69729-784-06) / 177 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69729-0784-06</NDC11Code>
<ProductNDC>69729-784</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rompe Tos X Children</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230918</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>250; 5; 13.33; 200</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL; mg/10mL</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>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold/flu symptoms: 1 sinus congestion & pressure, 2 minor aches & pains, 3 nasal congestion, 4 cough due to minor throat & bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promotes nasal and/or sinus drainage, 9 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>69729-785-06</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69729-785-06) / 177 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69729-0785-06</NDC11Code>
<ProductNDC>69729-785</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rompe Tos X Adults</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230918</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>500; 10; 26.66; 400</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL; mg/20mL; mg/20mL</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>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold/flu symptoms: 1 sinus congestion & pressure, 2 minor aches & pains, 3 nasal congestion, 4 cough due to minor throat & bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promotes nasal and/or sinus drainage, 9 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>69729-786-06</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69729-786-06) / 177 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69729-0786-06</NDC11Code>
<ProductNDC>69729-786</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tesalon Children</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guafeisin Usp, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240927</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>200; 13.33; 5; 250</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL; mg/10mL</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>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. temporarily relieves these common cold and flu symptoms: 1 sinus congestion and pressure, 2 minor aches and pains, 3 nasal congestion, 4 cough due to minor throat and bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promotes nasal and/or sinus drainage, 9 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>69729-787-06</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69729-787-06) / 177 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69729-0787-06</NDC11Code>
<ProductNDC>69729-787</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tesalon Jarabe Adulto</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin Usp, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240927</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>500; 26.66; 10; 400</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL; mg/20mL; mg/20mL</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>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms. sinus congestion and pressure minor aches and pains nasal congestion cough due to minor throat and bronchial irritation sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage 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>69729-789-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69729-789-06) / 177 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69729-0789-06</NDC11Code>
<ProductNDC>69729-789</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pentrexcilina Children Total Relief Multi-symptom</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin Usp, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>5; 250; 13.33; 200</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL; mg/10mL</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>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms: 1 sinus congestion and pressure, 2 minor aches and pains, 3 nasal congestion, 4 cough due to minor throat and bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promtoes nasal and/or sinus drainage, 9 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>69729-790-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69729-790-06) / 177 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69729-0790-06</NDC11Code>
<ProductNDC>69729-790</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pentrexcilina Adult Total Relief Multi-symptom</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin Usp, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>10; 500; 26.66; 400</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL; mg/20mL; mg/20mL</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>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms: 1 sinus congestion and pressure, 2 minor aches and pains, 3 nasal congestion, 4 cough due to minor throat and bronchial irritation, 5 sore throat, 6 headache, 7 temporarily reduces fever, 8 temporarily promotes nasal and/or sinus drainage, 9 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>69729-056-10</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (69729-056-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69729-0056-10</NDC11Code>
<ProductNDC>69729-056</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viro-flu Am Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>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>2026-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily reliever common cold/flu symptoms: 1 Cough due to minor throat & bronchial irritation, 2 Sore throat, 3 Headache, 4 Minor aches and pains, 5 Fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69729-122-37</NDCCode>
<PackageDescription>12 TABLET in 1 POUCH (69729-122-37) </PackageDescription>
<NDC11Code>69729-0122-37</NDC11Code>
<ProductNDC>69729-122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</ProprietaryName>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>OPMX LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 4; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms of hay fever or other respiratory allergies: 1 headache, 2 nasal congestion, 3 sinus congestion & pressure, 4 runny nose and sneezing, 5 minor aches & pain.</IndicationAndUsage>
</NDC>
</NDCList>