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},
{
"NDCCode": "65404-008-99",
"PackageDescription": "2000000 BAG in 1 DRUM (65404-008-99) / 2000000 BAG in 1 BAG (65404-008-02) / 2000000 mg in 1 BAG (65404-008-01) ",
"NDC11Code": "65404-0008-99",
"ProductNDC": "65404-008",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dapiprazole Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240630",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "AGC Pharma Chemicals Europe, S.L.U.",
"SubstanceName": "DAPIPRAZOLE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mg",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "30-JUN-24"
},
{
"NDCCode": "65862-008-99",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-008-99) ",
"NDC11Code": "65862-0008-99",
"ProductNDC": "65862-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077095",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050114",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride, USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg, and 1000 mg contains hypromellose and polyethylene glycol."
},
{
"NDCCode": "68594-008-99",
"PackageDescription": "45000 mL in 1 BOTTLE, GLASS (68594-008-99) ",
"NDC11Code": "68594-0008-99",
"ProductNDC": "68594-008",
"ProductTypeName": "VACCINE",
"NonProprietaryName": "Human Papillomavirus Type 11 L1 Protein Adsorbed",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20240122",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Boehringer Ingelheim RCV GmbH & Co KG",
"SubstanceName": "HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN",
"StrengthNumber": ".32",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2025-04-02",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "22-JAN-24"
},
{
"NDCCode": "69539-008-99",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (69539-008-99) ",
"NDC11Code": "69539-0008-99",
"ProductNDC": "69539-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208898",
"LabelerName": "MSN LABORATORIES PRIVATE LIMITED",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171122",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated. To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to:. o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis [(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl (methylsulfonyl) amino] pyrimidin-5-yl] (3R, 5S)-3, 5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium, USP is (C22H27FN3O6S)2 Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. Additionally, 10 mg, 20 mg and 40 mg tablets contain FD&C red No. 40/allura red AC aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake and FD&C yellow No.6/sunset yellow FCF aluminum lake. Meets USP Dissolution Test 2."
},
{
"NDCCode": "72119-008-01",
"PackageDescription": "99 g in 1 CAN (72119-008-01) ",
"NDC11Code": "72119-0008-01",
"ProductNDC": "72119-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dry Orignal Fresh 3.5oz",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231212",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "BLUE SEA AEROSOL & DAILY CARE CO., LTD",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "20.2",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231212",
"SamplePackage": "N",
"IndicationAndUsage": "Reduces underarm wetness."
},
{
"NDCCode": "75242-008-02",
"PackageDescription": "99 mL in 1 BOTTLE (75242-008-02) ",
"NDC11Code": "75242-0008-02",
"ProductNDC": "75242-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "75% Disinfectant Alcohol",
"NonProprietaryName": "75% Disinfectant Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200821",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "CANNAPRESSO HEALTH. INC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200821",
"SamplePackage": "N",
"IndicationAndUsage": "1. Human skin disinfection: Dip a cotton swab or cotton ball ( or spray) with an appropriate amount of disinfectant, and wipe the area to be treated 1-2 times for 1.5 minutes 2. Disinfect the surface of the object: use a cotton swab or cotton ball (or spray) to wipe the surface of the object with an appropriate amount of disinfectant for 1.5 minutes."
},
{
"NDCCode": "82157-010-99",
"PackageDescription": "1 KIT in 1 CARTON (82157-010-99) * 200 mL in 1 BOTTLE, PLASTIC (82157-008-20) * 100 mL in 1 BOTTLE, PLASTIC (82157-009-01) * 200 mL in 1 BOTTLE, PLASTIC (82157-007-20) ",
"NDC11Code": "82157-0010-99",
"ProductNDC": "82157-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nioxin Pro Clinical Scalp Recovery",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241219",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Wella Operations US LLC",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241219",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 Helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "84130-008-99",
"PackageDescription": "1 KIT in 1 KIT (84130-008-99) * 30 mL in 1 BOTTLE, PUMP (84130-001-10) * 150 mL in 1 BOTTLE, PUMP (84130-001-50) ",
"NDC11Code": "84130-0008-99",
"ProductNDC": "84130-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Essentials Spf Duo Kit",
"NonProprietaryName": "Avobenzone, Homosalate, Octocrylene, Octisalate",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240628",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Koco Life LLC",
"Status": "Active",
"LastUpdate": "2024-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240628",
"SamplePackage": "N",
"IndicationAndUsage": " Helps prevent sunburn. If used as directed with other sunprotection measures (see Directions),decreases the risk of skin cancer and earlyskin aging caused by the sun."
},
{
"NDCCode": "10006-008-01",
"PackageDescription": "283 L in 1 CYLINDER (10006-008-01)",
"NDC11Code": "10006-0008-01",
"ProductNDC": "10006-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium",
"NonProprietaryName": "Helium",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19360101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Acetylene Oxygen Company",
"SubstanceName": "HELIUM",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10006-008-02",
"PackageDescription": "425 L in 1 CYLINDER (10006-008-02)",
"NDC11Code": "10006-0008-02",
"ProductNDC": "10006-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium",
"NonProprietaryName": "Helium",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19360101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Acetylene Oxygen Company",
"SubstanceName": "HELIUM",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10006-008-03",
"PackageDescription": "566 L in 1 CYLINDER (10006-008-03)",
"NDC11Code": "10006-0008-03",
"ProductNDC": "10006-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium",
"NonProprietaryName": "Helium",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19360101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Acetylene Oxygen Company",
"SubstanceName": "HELIUM",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10006-008-04",
"PackageDescription": "2266 L in 1 CYLINDER (10006-008-04)",
"NDC11Code": "10006-0008-04",
"ProductNDC": "10006-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium",
"NonProprietaryName": "Helium",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19360101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Acetylene Oxygen Company",
"SubstanceName": "HELIUM",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10006-008-05",
"PackageDescription": "3455 L in 1 CYLINDER (10006-008-05)",
"NDC11Code": "10006-0008-05",
"ProductNDC": "10006-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium",
"NonProprietaryName": "Helium",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19360101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Acetylene Oxygen Company",
"SubstanceName": "HELIUM",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10006-008-06",
"PackageDescription": "6032 L in 1 CYLINDER (10006-008-06)",
"NDC11Code": "10006-0008-06",
"ProductNDC": "10006-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium",
"NonProprietaryName": "Helium",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19360101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Acetylene Oxygen Company",
"SubstanceName": "HELIUM",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54340-008-02",
"PackageDescription": "12 BOTTLE, DISPENSING in 1 CARTON (54340-008-02) / 325 mL in 1 BOTTLE, DISPENSING (54340-008-01) ",
"NDC11Code": "54340-0008-02",
"ProductNDC": "54340-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dial Antibacterial Chestnut Bliss Limited Seasonal",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250804",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Henkel Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250804",
"SamplePackage": "N",
"IndicationAndUsage": "Kills 99.99% bacteria. For handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "57915-008-01",
"PackageDescription": "59 g in 1 BOTTLE, SPRAY (57915-008-01) ",
"NDC11Code": "57915-0008-01",
"ProductNDC": "57915-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Germstar Premium Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Soaptronic LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "630",
"StrengthUnit": "g/1000g",
"Status": "Active",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Kills 99.99% of all disease causing germs on contact, and protects and restores moisture."
},
{
"NDCCode": "57915-008-02",
"PackageDescription": "59 g in 1 BOTTLE, SPRAY (57915-008-02) ",
"NDC11Code": "57915-0008-02",
"ProductNDC": "57915-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Germstar Premium Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Soaptronic LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "630",
"StrengthUnit": "g/1000g",
"Status": "Active",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Kills 99.99% of all disease causing germs on contact, and protects and restores moisture."
},
{
"NDCCode": "57915-008-03",
"PackageDescription": "59 g in 1 BOTTLE, SPRAY (57915-008-03) ",
"NDC11Code": "57915-0008-03",
"ProductNDC": "57915-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Germstar Premium Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Soaptronic LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "630",
"StrengthUnit": "g/1000g",
"Status": "Active",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Kills 99.99% of all disease causing germs on contact, and protects and restores moisture."
},
{
"NDCCode": "57915-008-04",
"PackageDescription": "59 g in 1 BOTTLE, SPRAY (57915-008-04) ",
"NDC11Code": "57915-0008-04",
"ProductNDC": "57915-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Germstar Premium Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Soaptronic LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "630",
"StrengthUnit": "g/1000g",
"Status": "Active",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Kills 99.99% of all disease causing germs on contact, and protects and restores moisture."
},
{
"NDCCode": "57915-008-05",
"PackageDescription": "59 g in 1 BOTTLE, SPRAY (57915-008-05) ",
"NDC11Code": "57915-0008-05",
"ProductNDC": "57915-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Germstar Premium Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Soaptronic LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "630",
"StrengthUnit": "g/1000g",
"Status": "Active",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Kills 99.99% of all disease causing germs on contact, and protects and restores moisture."
},
{
"NDCCode": "63189-008-20",
"PackageDescription": "140000 TABLET in 1 CONTAINER (63189-008-20) ",
"NDC11Code": "63189-0008-20",
"ProductNDC": "63189-008",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Phenazopyridine Hydrochloride",
"DosageFormName": "TABLET",
"StartMarketingDate": "20180507",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Amol Pharmaceuticals Private Limited",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "99.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "07-MAY-18",
"EndMarketingDatePackage": "28-FEB-26"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>59767-008-99</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-008-99) </PackageDescription>
<NDC11Code>59767-0008-99</NDC11Code>
<ProductNDC>59767-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pertzye</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
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<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>420</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20081230</StartMarketingDatePackage>
<EndMarketingDatePackage>20200814</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47682-008-48</NDCCode>
<PackageDescription>125 PACKET in 1 BOX (47682-008-48) > 2 TABLET, CHEWABLE in 1 PACKET (47682-008-99) </PackageDescription>
<NDC11Code>47682-0008-48</NDC11Code>
<ProductNDC>47682-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Green Guard Stomach Relief</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081230</StartMarketingDate>
<EndMarketingDate>20200814</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>420</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20081230</StartMarketingDatePackage>
<EndMarketingDatePackage>20200814</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65404-008-99</NDCCode>
<PackageDescription>2000000 BAG in 1 DRUM (65404-008-99) / 2000000 BAG in 1 BAG (65404-008-02) / 2000000 mg in 1 BAG (65404-008-01) </PackageDescription>
<NDC11Code>65404-0008-99</NDC11Code>
<ProductNDC>65404-008</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dapiprazole Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240630</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>AGC Pharma Chemicals Europe, S.L.U.</LabelerName>
<SubstanceName>DAPIPRAZOLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-JUN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65862-008-99</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (65862-008-99) </PackageDescription>
<NDC11Code>65862-0008-99</NDC11Code>
<ProductNDC>65862-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077095</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride, USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg, and 1000 mg contains hypromellose and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>68594-008-99</NDCCode>
<PackageDescription>45000 mL in 1 BOTTLE, GLASS (68594-008-99) </PackageDescription>
<NDC11Code>68594-0008-99</NDC11Code>
<ProductNDC>68594-008</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<NonProprietaryName>Human Papillomavirus Type 11 L1 Protein Adsorbed</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20240122</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Boehringer Ingelheim RCV GmbH & Co KG</LabelerName>
<SubstanceName>HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN</SubstanceName>
<StrengthNumber>.32</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-04-02</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-JAN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>69539-008-99</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (69539-008-99) </PackageDescription>
<NDC11Code>69539-0008-99</NDC11Code>
<ProductNDC>69539-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208898</ApplicationNumber>
<LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated. To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to:. o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis [(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl (methylsulfonyl) amino] pyrimidin-5-yl] (3R, 5S)-3, 5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium, USP is (C22H27FN3O6S)2 Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. Additionally, 10 mg, 20 mg and 40 mg tablets contain FD&C red No. 40/allura red AC aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake and FD&C yellow No.6/sunset yellow FCF aluminum lake. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>72119-008-01</NDCCode>
<PackageDescription>99 g in 1 CAN (72119-008-01) </PackageDescription>
<NDC11Code>72119-0008-01</NDC11Code>
<ProductNDC>72119-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dry Orignal Fresh 3.5oz</ProprietaryName>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>BLUE SEA AEROSOL & DAILY CARE CO., LTD</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>20.2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75242-008-02</NDCCode>
<PackageDescription>99 mL in 1 BOTTLE (75242-008-02) </PackageDescription>
<NDC11Code>75242-0008-02</NDC11Code>
<ProductNDC>75242-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>75% Disinfectant Alcohol</ProprietaryName>
<NonProprietaryName>75% Disinfectant Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200821</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>CANNAPRESSO HEALTH. INC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Human skin disinfection: Dip a cotton swab or cotton ball ( or spray) with an appropriate amount of disinfectant, and wipe the area to be treated 1-2 times for 1.5 minutes 2. Disinfect the surface of the object: use a cotton swab or cotton ball (or spray) to wipe the surface of the object with an appropriate amount of disinfectant for 1.5 minutes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82157-010-99</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (82157-010-99) * 200 mL in 1 BOTTLE, PLASTIC (82157-008-20) * 100 mL in 1 BOTTLE, PLASTIC (82157-009-01) * 200 mL in 1 BOTTLE, PLASTIC (82157-007-20) </PackageDescription>
<NDC11Code>82157-0010-99</NDC11Code>
<ProductNDC>82157-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nioxin Pro Clinical Scalp Recovery</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241219</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Wella Operations US LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241219</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 Helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84130-008-99</NDCCode>
<PackageDescription>1 KIT in 1 KIT (84130-008-99) * 30 mL in 1 BOTTLE, PUMP (84130-001-10) * 150 mL in 1 BOTTLE, PUMP (84130-001-50) </PackageDescription>
<NDC11Code>84130-0008-99</NDC11Code>
<ProductNDC>84130-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sun Essentials Spf Duo Kit</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octocrylene, Octisalate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240628</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Koco Life LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps prevent sunburn. If used as directed with other sunprotection measures (see Directions),decreases the risk of skin cancer and earlyskin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10006-008-01</NDCCode>
<PackageDescription>283 L in 1 CYLINDER (10006-008-01)</PackageDescription>
<NDC11Code>10006-0008-01</NDC11Code>
<ProductNDC>10006-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium</ProprietaryName>
<NonProprietaryName>Helium</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19360101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Acetylene Oxygen Company</LabelerName>
<SubstanceName>HELIUM</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10006-008-02</NDCCode>
<PackageDescription>425 L in 1 CYLINDER (10006-008-02)</PackageDescription>
<NDC11Code>10006-0008-02</NDC11Code>
<ProductNDC>10006-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium</ProprietaryName>
<NonProprietaryName>Helium</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19360101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Acetylene Oxygen Company</LabelerName>
<SubstanceName>HELIUM</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10006-008-03</NDCCode>
<PackageDescription>566 L in 1 CYLINDER (10006-008-03)</PackageDescription>
<NDC11Code>10006-0008-03</NDC11Code>
<ProductNDC>10006-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium</ProprietaryName>
<NonProprietaryName>Helium</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19360101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Acetylene Oxygen Company</LabelerName>
<SubstanceName>HELIUM</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10006-008-04</NDCCode>
<PackageDescription>2266 L in 1 CYLINDER (10006-008-04)</PackageDescription>
<NDC11Code>10006-0008-04</NDC11Code>
<ProductNDC>10006-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium</ProprietaryName>
<NonProprietaryName>Helium</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19360101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Acetylene Oxygen Company</LabelerName>
<SubstanceName>HELIUM</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10006-008-05</NDCCode>
<PackageDescription>3455 L in 1 CYLINDER (10006-008-05)</PackageDescription>
<NDC11Code>10006-0008-05</NDC11Code>
<ProductNDC>10006-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium</ProprietaryName>
<NonProprietaryName>Helium</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19360101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Acetylene Oxygen Company</LabelerName>
<SubstanceName>HELIUM</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10006-008-06</NDCCode>
<PackageDescription>6032 L in 1 CYLINDER (10006-008-06)</PackageDescription>
<NDC11Code>10006-0008-06</NDC11Code>
<ProductNDC>10006-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium</ProprietaryName>
<NonProprietaryName>Helium</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19360101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Acetylene Oxygen Company</LabelerName>
<SubstanceName>HELIUM</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54340-008-02</NDCCode>
<PackageDescription>12 BOTTLE, DISPENSING in 1 CARTON (54340-008-02) / 325 mL in 1 BOTTLE, DISPENSING (54340-008-01) </PackageDescription>
<NDC11Code>54340-0008-02</NDC11Code>
<ProductNDC>54340-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dial Antibacterial Chestnut Bliss Limited Seasonal</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250804</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Henkel Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Kills 99.99% bacteria. For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57915-008-01</NDCCode>
<PackageDescription>59 g in 1 BOTTLE, SPRAY (57915-008-01) </PackageDescription>
<NDC11Code>57915-0008-01</NDC11Code>
<ProductNDC>57915-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Germstar Premium Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Soaptronic LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>630</StrengthNumber>
<StrengthUnit>g/1000g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Kills 99.99% of all disease causing germs on contact, and protects and restores moisture.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>59 g in 1 BOTTLE, SPRAY (57915-008-02) </PackageDescription>
<NDC11Code>57915-0008-02</NDC11Code>
<ProductNDC>57915-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Germstar Premium Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Soaptronic LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>630</StrengthNumber>
<StrengthUnit>g/1000g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Kills 99.99% of all disease causing germs on contact, and protects and restores moisture.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57915-008-03</NDCCode>
<PackageDescription>59 g in 1 BOTTLE, SPRAY (57915-008-03) </PackageDescription>
<NDC11Code>57915-0008-03</NDC11Code>
<ProductNDC>57915-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Germstar Premium Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Soaptronic LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>630</StrengthNumber>
<StrengthUnit>g/1000g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Kills 99.99% of all disease causing germs on contact, and protects and restores moisture.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57915-008-04</NDCCode>
<PackageDescription>59 g in 1 BOTTLE, SPRAY (57915-008-04) </PackageDescription>
<NDC11Code>57915-0008-04</NDC11Code>
<ProductNDC>57915-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Germstar Premium Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Soaptronic LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>630</StrengthNumber>
<StrengthUnit>g/1000g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Kills 99.99% of all disease causing germs on contact, and protects and restores moisture.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57915-008-05</NDCCode>
<PackageDescription>59 g in 1 BOTTLE, SPRAY (57915-008-05) </PackageDescription>
<NDC11Code>57915-0008-05</NDC11Code>
<ProductNDC>57915-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Germstar Premium Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Soaptronic LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>630</StrengthNumber>
<StrengthUnit>g/1000g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Kills 99.99% of all disease causing germs on contact, and protects and restores moisture.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63189-008-20</NDCCode>
<PackageDescription>140000 TABLET in 1 CONTAINER (63189-008-20) </PackageDescription>
<NDC11Code>63189-0008-20</NDC11Code>
<ProductNDC>63189-008</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20180507</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Amol Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>99.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>07-MAY-18</StartMarketingDatePackage>
<EndMarketingDatePackage>28-FEB-26</EndMarketingDatePackage>
</NDC>
</NDCList>