{
"NDC": [
{
"NDCCode": "66715-5607-4",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (66715-5607-4) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "66715-5607-04",
"ProductNDC": "66715-5607",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen, Circle K, 50ct",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079129",
"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": "2024-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to:, 2 headache, 3 muscular aches, 4 minor pain of arthritis, 5 toothache backache, 6 the common cold, 7 menstrual cramps, 8 temporarily reduces fever."
},
{
"NDCCode": "22840-5607-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-5607-4) ",
"NDC11Code": "22840-5607-04",
"ProductNDC": "22840-5607",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Aureobasidium Pullulans",
"NonProprietaryName": "Aureobasidium Pullulans",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "AUREOBASIDIUM PULLULANS VAR. PULLUTANS",
"StrengthNumber": ".025",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).",
"Description": "Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen."
},
{
"NDCCode": "0548-5607-00",
"PackageDescription": "10 SYRINGE in 1 CARTON (0548-5607-00) / 1 mL in 1 SYRINGE",
"NDC11Code": "00548-5607-00",
"ProductNDC": "0548-5607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enoxaparin Sodium",
"NonProprietaryName": "Enoxaparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20110919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076684",
"LabelerName": "Amphastar Pharmaceuticals, Inc.",
"SubstanceName": "ENOXAPARIN SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110919",
"SamplePackage": "N",
"IndicationAndUsage": "Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1), 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2), 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2), 4 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3), 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4).",
"Description": "Enoxaparin Sodium Injection USP is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5.Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6 anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is."
},
{
"NDCCode": "0781-5607-31",
"PackageDescription": "30 TABLET in 1 BOTTLE (0781-5607-31)",
"NDC11Code": "00781-5607-31",
"ProductNDC": "0781-5607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140707",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021283",
"LabelerName": "Sandoz Inc",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Valsartan Tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Treatment of heart failure (NYHA class II-IV); Valsartan Tablets, USP significantly reduced hospitalization for heart failure (1.2), 3 Reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction (1.3).",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan Tablets, USP are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides (yellow, black and/or red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide."
},
{
"NDCCode": "22840-5607-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-5607-2) ",
"NDC11Code": "22840-5607-02",
"ProductNDC": "22840-5607",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Aureobasidium Pullulans",
"NonProprietaryName": "Aureobasidium Pullulans",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "AUREOBASIDIUM PULLULANS VAR. PULLUTANS",
"StrengthNumber": ".025",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).",
"Description": "Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen."
},
{
"NDCCode": "22840-5607-5",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (22840-5607-5) ",
"NDC11Code": "22840-5607-05",
"ProductNDC": "22840-5607",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Aureobasidium Pullulans",
"NonProprietaryName": "Aureobasidium Pullulans",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "AUREOBASIDIUM PULLULANS VAR. PULLUTANS",
"StrengthNumber": ".025",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).",
"Description": "Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen."
},
{
"NDCCode": "54868-5607-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54868-5607-0)",
"NDC11Code": "54868-5607-00",
"ProductNDC": "54868-5607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diovan Hct",
"NonProprietaryName": "Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081204",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020818",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "VALSARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "320; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of <140 mmHg (systolic) and 60% likelihood of achieving <90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
"Description": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "54868-5607-1",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (54868-5607-1)",
"NDC11Code": "54868-5607-01",
"ProductNDC": "54868-5607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diovan Hct",
"NonProprietaryName": "Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081204",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020818",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "VALSARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "320; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of <140 mmHg (systolic) and 60% likelihood of achieving <90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
"Description": "Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "66715-4644-4",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (66715-4644-4) / 6 TABLET in 1 BLISTER PACK",
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"ProprietaryName": "Anti-diarrheal, 24/7 Life By 7-eleven",
"NonProprietaryName": "Loperamide Hcl Tablet",
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"ApplicationNumber": "ANDA076497",
"LabelerName": "Lil' Drug Store Products, Inc.",
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"StrengthUnit": "mg/1",
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"LastUpdate": "2025-06-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220914",
"SamplePackage": "N",
"IndicationAndUsage": "Use. controls symptoms of diarrhea, including Travelers’ Diarrhea."
},
{
"NDCCode": "66715-5428-4",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (66715-5428-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "66715-5428-04",
"ProductNDC": "66715-5428",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "24/7 Life By 7-eleven Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium Tablet, Film Coated",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204872",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220419",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to:, 2 headache, 3 muscular aches, 4 the common cold, 5 toothache, 6 menstrual cramps, 7 backache, 8 minor pain of arthritis, 9 temporarily reduces fever."
},
{
"NDCCode": "66715-5429-4",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (66715-5429-4) / 15 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "66715-5429-04",
"ProductNDC": "66715-5429",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Redness Reliever, Circle K",
"NonProprietaryName": "Tetrahydrozoline Hydrochloride Liquid",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20160226",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Lil' Drug Store products, Inc.",
"SubstanceName": "TETRAHYDROZOLINE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160226",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 relieves redness of the eye due to minor eye irritations."
},
{
"NDCCode": "66715-5460-4",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (66715-5460-4) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "66715-5460-04",
"ProductNDC": "66715-5460",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasal Spray, Circle K",
"NonProprietaryName": "Oxymetazoline Hydrochloride 0.05% Solution",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20251001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251001",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves nasal congestion due to:, 2 common cold, 3 hay fever, 4 upper respiratory allergies, 5 temporarily relieves sinus congestion and pressure, 6 shrinks swollen nasal membranes so you can breathe more freely."
},
{
"NDCCode": "66715-5504-4",
"PackageDescription": "100 TABLET in 1 BOTTLE (66715-5504-4) ",
"NDC11Code": "66715-5504-04",
"ProductNDC": "66715-5504",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Aspirin 325",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211110",
"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": "20211110",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: 1 headache, 2 muscle pain, 3 toothache, 4 menstrual pain, 5 pain and fever of colds, 6 minor pain of arthritis."
},
{
"NDCCode": "66715-5506-4",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (66715-5506-4) / 50 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "66715-5506-04",
"ProductNDC": "66715-5506",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Headache, Circle K",
"NonProprietaryName": "Acetaminophen/aspirin/caffeine Tablet",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210924",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ASPIRIN; CAFFEINE; ACETAMINOPHEN",
"StrengthNumber": "250; 65; 250",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210924",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to:, 2 headache, 3 a cold, 4 arthritis, 5 muscular aches, 6 sinusitis, 7 toothache, 8 premenstrual and menstrual cramps."
},
{
"NDCCode": "66715-5507-4",
"PackageDescription": "1 BOTTLE in 1 CARTON (66715-5507-4) > 50 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "66715-5507-04",
"ProductNDC": "66715-5507",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079174",
"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": "2022-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210817",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachetoothachebackachemenstrual crampsthe common coldmuscular achesminor pain of arthritis. temporarily reduces fever."
},
{
"NDCCode": "66715-5508-4",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (66715-5508-4) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "66715-5508-04",
"ProductNDC": "66715-5508",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Pain Reliever",
"NonProprietaryName": "Acetaminophen Caplets, 500 Mg",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210907",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210907",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains. due to:. the common cold. headache. backache. minor pain of arthritis. toothache. muscular aches. premenstrual and menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "66715-5526-4",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (66715-5526-4) / 30 mL in 1 BOTTLE, PUMP",
"NDC11Code": "66715-5526-04",
"ProductNDC": "66715-5526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasal Spray, 1oz, 24/7 Life By 7-eleven",
"NonProprietaryName": "Oxymetazoline Hcl Nasal Solution 0.05%",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20251001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251001",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves nasal congestion due to:, 2 common cold, 3 hay fever, 4 upper respiratory allergies, 5 temporarily relieves sinus congestion and pressure, 6 shrinks swollen nasal membranes so you can breathe more freely."
},
{
"NDCCode": "66715-5531-4",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (66715-5531-4) ",
"NDC11Code": "66715-5531-04",
"ProductNDC": "66715-5531",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Daytime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210807",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210807",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms minor aches and painsheadachesore throatnasal congestionfeversinus pressurecough due to minor throat and bronchial irritation."
},
{
"NDCCode": "66715-5534-4",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (66715-5534-4) ",
"NDC11Code": "66715-5534-04",
"ProductNDC": "66715-5534",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210803",
"EndMarketingDate": "20280212",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210803",
"EndMarketingDatePackage": "20280212",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold/flu symptoms: minor aches and painsheadachesore throatrunny nose and sneezingfevercough due to minor throat and bronchial irritation."
},
{
"NDCCode": "66715-5555-4",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (66715-5555-4) ",
"NDC11Code": "66715-5555-04",
"ProductNDC": "66715-5555",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stomach",
"ProprietaryNameSuffix": "Circle K",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20141201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Lil' Drug Store Products, Inc",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "525",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210305",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 diarrhea, 2 travelers' diarrhea, 3 upset stomach due to overindulgence in food and drink, including heartburngasindigestionnauseafullnessbelching."
},
{
"NDCCode": "66715-5560-4",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (66715-5560-4) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "66715-5560-04",
"ProductNDC": "66715-5560",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K",
"ProprietaryNameSuffix": "Congestion Relief",
"NonProprietaryName": "Oxymetazoline Hydrochloride",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20210624",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210624",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves nasal congestion due to: common coldhay feverupper respiratory allergies. Shrinks swollen nasal membranes so you can breathe more freely."
},
{
"NDCCode": "66715-5626-4",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (66715-5626-4) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "66715-5626-04",
"ProductNDC": "66715-5626",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasal Spray, 24-7 For Life",
"NonProprietaryName": "Oxymetazoline Hydrochloride 0.05%",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20220419",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220419",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves nasal congestion due to:, 2 common cold, 3 hay fever, 4 upper respiratory allergies, 5 temporarily relieves sinus congestion and pressure, 6 shrinks swollen nasal membranes so you can breathe more freely."
},
{
"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": "66715-5637-4",
"PackageDescription": "1 BOTTLE in 1 CARTON (66715-5637-4) > 24 TABLET in 1 BOTTLE",
"NDC11Code": "66715-5637-04",
"ProductNDC": "66715-5637",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Circle K Pain Reliever",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141101",
"EndMarketingDate": "20221017",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Lil' Drug Store Products, Inc",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160804",
"EndMarketingDatePackage": "20221017",
"SamplePackage": "N"
},
{
"NDCCode": "66715-5640-4",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (66715-5640-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "66715-5640-04",
"ProductNDC": "66715-5640",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Reliever Pm, Extra Strength, 24-7 Life By 7-eleven",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl Tablet, Film Coated",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220419",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "25; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220419",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness."
},
{
"NDCCode": "66715-5641-4",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (66715-5641-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "66715-5641-04",
"ProductNDC": "66715-5641",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Headache Relief, Extra Strength",
"ProprietaryNameSuffix": "24/7 Life By 7-eleven",
"NonProprietaryName": "Acetaminophen, Aspirin, Caffeine 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; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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},
{
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"PackageDescription": "1 BLISTER PACK in 1 CARTON (66715-5642-4) / 16 TABLET in 1 BLISTER PACK",
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"ProductNDC": "66715-5642",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Sleep Aid, 24-7 Life By 7-eleven",
"NonProprietaryName": "Doxylamine Succinate Tablet",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220419",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220419",
"SamplePackage": "N",
"IndicationAndUsage": "Use: 1 helps to reduce difficulty in falling asleep."
},
{
"NDCCode": "66715-5644-4",
"PackageDescription": "6 POUCH in 1 CARTON (66715-5644-4) / 2 TABLET in 1 POUCH",
"NDC11Code": "66715-5644-04",
"ProductNDC": "66715-5644",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-diarrheal 24/7 For Life By 7-eleven",
"NonProprietaryName": "Loperamide Hcl Tablet",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076497",
"LabelerName": "Lil' Drug Store Products, Inc.",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220419",
"SamplePackage": "N",
"IndicationAndUsage": "Use. controls symptoms of diarrhea, including Travelers’ Diarrhea."
},
{
"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",
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"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."
}
]
}
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<StrengthUnit>mg/1</StrengthUnit>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>22840-5607-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-5607-4) </PackageDescription>
<NDC11Code>22840-5607-04</NDC11Code>
<ProductNDC>22840-5607</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Aureobasidium Pullulans</ProprietaryName>
<NonProprietaryName>Aureobasidium Pullulans</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>AUREOBASIDIUM PULLULANS VAR. PULLUTANS</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen.</Description>
</NDC>
<NDC>
<NDCCode>0548-5607-00</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (0548-5607-00) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00548-5607-00</NDC11Code>
<ProductNDC>0548-5607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enoxaparin Sodium</ProprietaryName>
<NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20110919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076684</ApplicationNumber>
<LabelerName>Amphastar Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1), 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2), 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2), 4 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3), 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4).</IndicationAndUsage>
<Description>Enoxaparin Sodium Injection USP is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5.Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6 anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is.</Description>
</NDC>
<NDC>
<NDCCode>0781-5607-31</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0781-5607-31)</PackageDescription>
<NDC11Code>00781-5607-31</NDC11Code>
<ProductNDC>0781-5607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140707</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021283</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Valsartan Tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Treatment of heart failure (NYHA class II-IV); Valsartan Tablets, USP significantly reduced hospitalization for heart failure (1.2), 3 Reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction (1.3).</IndicationAndUsage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan Tablets, USP are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides (yellow, black and/or red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>22840-5607-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-5607-2) </PackageDescription>
<NDC11Code>22840-5607-02</NDC11Code>
<ProductNDC>22840-5607</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Aureobasidium Pullulans</ProprietaryName>
<NonProprietaryName>Aureobasidium Pullulans</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>AUREOBASIDIUM PULLULANS VAR. PULLUTANS</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen.</Description>
</NDC>
<NDC>
<NDCCode>22840-5607-5</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (22840-5607-5) </PackageDescription>
<NDC11Code>22840-5607-05</NDC11Code>
<ProductNDC>22840-5607</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Aureobasidium Pullulans</ProprietaryName>
<NonProprietaryName>Aureobasidium Pullulans</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>AUREOBASIDIUM PULLULANS VAR. PULLUTANS</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen.</Description>
</NDC>
<NDC>
<NDCCode>54868-5607-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (54868-5607-0)</PackageDescription>
<NDC11Code>54868-5607-00</NDC11Code>
<ProductNDC>54868-5607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diovan Hct</ProprietaryName>
<NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081204</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020818</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>320; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of <140 mmHg (systolic) and 60% likelihood of achieving <90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
<Description>Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.</Description>
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<IndicationAndUsage>Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy. Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of <140 mmHg (systolic) and 60% likelihood of achieving <90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
<Description>Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.</Description>
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<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>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Uses: 1 temporarily relieves nasal congestion due to:, 2 common cold, 3 hay fever, 4 upper respiratory allergies, 5 temporarily relieves sinus congestion and pressure, 6 shrinks swollen nasal membranes so you can breathe more freely.</IndicationAndUsage>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 headache, 2 muscle pain, 3 toothache, 4 menstrual pain, 5 pain and fever of colds, 6 minor pain of arthritis.</IndicationAndUsage>
</NDC>
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<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
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<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
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<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:, 2 headache, 3 a cold, 4 arthritis, 5 muscular aches, 6 sinusitis, 7 toothache, 8 premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachetoothachebackachemenstrual crampsthe common coldmuscular achesminor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210907</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains. due to:. the common cold. headache. backache. minor pain of arthritis. toothache. muscular aches. premenstrual and menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
</NDC>
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<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves nasal congestion due to:, 2 common cold, 3 hay fever, 4 upper respiratory allergies, 5 temporarily relieves sinus congestion and pressure, 6 shrinks swollen nasal membranes so you can breathe more freely.</IndicationAndUsage>
</NDC>
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<ProductNDC>66715-5531</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Daytime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210807</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms minor aches and painsheadachesore throatnasal congestionfeversinus pressurecough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5534-4</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (66715-5534-4) </PackageDescription>
<NDC11Code>66715-5534-04</NDC11Code>
<ProductNDC>66715-5534</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210803</StartMarketingDate>
<EndMarketingDate>20280212</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>650; 30; 12.5</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210803</StartMarketingDatePackage>
<EndMarketingDatePackage>20280212</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold/flu symptoms: minor aches and painsheadachesore throatrunny nose and sneezingfevercough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5555-4</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (66715-5555-4) </PackageDescription>
<NDC11Code>66715-5555-04</NDC11Code>
<ProductNDC>66715-5555</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stomach</ProprietaryName>
<ProprietaryNameSuffix>Circle K</ProprietaryNameSuffix>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>525</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Bismuth [CS], Bismuth [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 diarrhea, 2 travelers' diarrhea, 3 upset stomach due to overindulgence in food and drink, including heartburngasindigestionnauseafullnessbelching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5560-4</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (66715-5560-4) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>66715-5560-04</NDC11Code>
<ProductNDC>66715-5560</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K</ProprietaryName>
<ProprietaryNameSuffix>Congestion Relief</ProprietaryNameSuffix>
<NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20210624</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves nasal congestion due to: common coldhay feverupper respiratory allergies. Shrinks swollen nasal membranes so you can breathe more freely.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5626-4</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (66715-5626-4) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>66715-5626-04</NDC11Code>
<ProductNDC>66715-5626</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasal Spray, 24-7 For Life</ProprietaryName>
<NonProprietaryName>Oxymetazoline Hydrochloride 0.05%</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves nasal congestion due to:, 2 common cold, 3 hay fever, 4 upper respiratory allergies, 5 temporarily relieves sinus congestion and pressure, 6 shrinks swollen nasal membranes so you can breathe more freely.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5635-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5635-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5635-04</NDC11Code>
<ProductNDC>66715-5635</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Reliever, 24/7 Life By 7-eleven</ProprietaryName>
<NonProprietaryName>Acetaminophen Tablet, Film Coated</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:, 2 headache, 3 the common cold, 4 backach, 5 minor pain from arthritis, 6 toothache, 7 muscular aches, 8 premenstrual and menstrual cramps, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5637-4</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (66715-5637-4) > 24 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>66715-5637-04</NDC11Code>
<ProductNDC>66715-5637</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Circle K Pain Reliever</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141101</StartMarketingDate>
<EndMarketingDate>20221017</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160804</StartMarketingDatePackage>
<EndMarketingDatePackage>20221017</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66715-5640-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5640-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5640-04</NDC11Code>
<ProductNDC>66715-5640</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Reliever Pm, Extra Strength, 24-7 Life By 7-eleven</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hcl Tablet, Film Coated</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>25; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5641-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5641-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5641-04</NDC11Code>
<ProductNDC>66715-5641</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Headache Relief, Extra Strength</ProprietaryName>
<ProprietaryNameSuffix>24/7 Life By 7-eleven</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin, Caffeine Tablet, Film Coated</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. temporarily relieves minor aches and pains due to: 1 a cold, 2 toothache, 3 arthritis, 4 muscular aches, 5 headache, 6 premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5642-4</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (66715-5642-4) / 16 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66715-5642-04</NDC11Code>
<ProductNDC>66715-5642</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Sleep Aid, 24-7 Life By 7-eleven</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate Tablet</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use: 1 helps to reduce difficulty in falling asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5644-4</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (66715-5644-4) / 2 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>66715-5644-04</NDC11Code>
<ProductNDC>66715-5644</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-diarrheal 24/7 For Life By 7-eleven</ProprietaryName>
<NonProprietaryName>Loperamide Hcl Tablet</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076497</ApplicationNumber>
<LabelerName>Lil' Drug Store Products, Inc.</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. controls symptoms of diarrhea, including Travelers’ Diarrhea.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66715-5646-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (66715-5646-4) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>66715-5646-04</NDC11Code>
<ProductNDC>66715-5646</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen, Solubilized</ProprietaryName>
<ProprietaryNameSuffix>24/7 Life By 7-eleven</ProprietaryNameSuffix>
<NonProprietaryName>Ibuprofen Capsule, Liquid Filled</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078682</ApplicationNumber>
<LabelerName>Lil' Drug Store products, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:, 2 minor pain of arthritis, 3 headache, 4 the common cold, 5 backache, 6 menstrual cramps, 7 toothache, 8 muscular aches, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<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>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Pain Reliever</ProprietaryName>
<NonProprietaryName>Acetaminophen 500 Mg, Film-coated Caplet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220509</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>2025-01-01</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>
</NDCList>