{
"NDC": [
{
"NDCCode": "63083-8002-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-8002-2) ",
"NDC11Code": "63083-8002-02",
"ProductNDC": "63083-8002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Phosphorica",
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"NonProprietaryName": "Calcarea Phosphorica",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "10884-8002-2",
"PackageDescription": "100 mL in 1 BOTTLE (10884-8002-2) ",
"NDC11Code": "10884-8002-02",
"ProductNDC": "10884-8002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "80% Alcohol Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Bright Future Pharmaceutical Laboratories Limited",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N"
},
{
"NDCCode": "11822-8002-2",
"PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (11822-8002-2) ",
"NDC11Code": "11822-8002-02",
"ProductNDC": "11822-8002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Sleep-aid",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230519",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230519",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep."
},
{
"NDCCode": "11822-8002-9",
"PackageDescription": "2 BOTTLE, PLASTIC in 1 PACKAGE (11822-8002-9) / 355 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "11822-8002-09",
"ProductNDC": "11822-8002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Sleep-aid",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230519",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230519",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep."
},
{
"NDCCode": "58597-8002-2",
"PackageDescription": "500 mg in 1 VIAL (58597-8002-2)",
"NDC11Code": "58597-8002-02",
"ProductNDC": "58597-8002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130813",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "AMERICAN PHARMACEUTICAL INGREDIENTS LLC",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "1",
"StrengthUnit": "mg/mg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "60681-8002-1",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (60681-8002-1) > 2 mL in 1 VIAL, GLASS",
"NDC11Code": "60681-8002-01",
"ProductNDC": "60681-8002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pleo Citro",
"NonProprietaryName": "Citric Acid",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19970319",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sanum Kehlbeck GmbH & Co. KG",
"SubstanceName": "CITRIC ACID; CITRIC ACID; CITRIC ACID",
"StrengthNumber": "10; 30; 200",
"StrengthUnit": "[HP_X]/2mL; [HP_X]/2mL; [HP_X]/2mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For symptoms of allergies and the common cold."
},
{
"NDCCode": "60681-8002-2",
"PackageDescription": "50 VIAL, GLASS in 1 CARTON (60681-8002-2) > 2 mL in 1 VIAL, GLASS",
"NDC11Code": "60681-8002-02",
"ProductNDC": "60681-8002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pleo Citro",
"NonProprietaryName": "Citric Acid",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19970319",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sanum Kehlbeck GmbH & Co. KG",
"SubstanceName": "CITRIC ACID; CITRIC ACID; CITRIC ACID",
"StrengthNumber": "10; 30; 200",
"StrengthUnit": "[HP_X]/2mL; [HP_X]/2mL; [HP_X]/2mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For symptoms of allergies and the common cold."
},
{
"NDCCode": "62112-8002-2",
"PackageDescription": "25000 CAPSULE, GELATIN COATED in 1 BOX (62112-8002-2)",
"NDC11Code": "62112-8002-02",
"ProductNDC": "62112-8002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Simethicone",
"DosageFormName": "CAPSULE, GELATIN COATED",
"StartMarketingDate": "19980301",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Intergel Pharmaceuticals inc",
"SubstanceName": "DIMETHICONE; SILICON DIOXIDE",
"StrengthNumber": "118.44; 6.56",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "68210-8002-2",
"PackageDescription": "44 BLISTER PACK in 1 BOX (68210-8002-2) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "68210-8002-02",
"ProductNDC": "68210-8002",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Spirit Pharmaceuticals LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "01-JUN-15"
},
{
"NDCCode": "69096-8002-2",
"PackageDescription": "150 g in 1 CARTON (69096-8002-2) ",
"NDC11Code": "69096-8002-02",
"ProductNDC": "69096-8002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Linea Jose Ignacio Sunscreen Broad Spectrum Spf 30 With Zinc",
"NonProprietaryName": "Sunscreen Broad Spectrum Sfp 30 With Zinc",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Linea Jose Ignacio LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "30",
"StrengthUnit": "g/150g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N"
},
{
"NDCCode": "72326-8002-2",
"PackageDescription": "120 g in 1 TUBE (72326-8002-2) ",
"NDC11Code": "72326-8002-02",
"ProductNDC": "72326-8002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Plak Smacker Anti Cavity Fluoride",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "DENTAL",
"StartMarketingDate": "20180527",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "YOUNG PS ACQUISITION, LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.4",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2023-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230712",
"SamplePackage": "N",
"IndicationAndUsage": "Aids in the prevention of dental cavities."
},
{
"NDCCode": "76344-8002-2",
"PackageDescription": "1 TUBE in 1 BOX (76344-8002-2) > 50 g in 1 TUBE (76344-8002-1) ",
"NDC11Code": "76344-8002-02",
"ProductNDC": "76344-8002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Post Rays Uv Protect Sun Block",
"NonProprietaryName": "Zinc Oxide,octinoxate, Octisalate,titamium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Humex,Inc",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "6.8; 4.5; 4.0014; 5.006",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191201",
"SamplePackage": "N"
},
{
"NDCCode": "0264-8002-32",
"PackageDescription": "30 CONTAINER in 1 CASE (0264-8002-32) / 100 mL in 1 CONTAINER",
"NDC11Code": "00264-8002-32",
"ProductNDC": "0264-8002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midazolam In 0.8% Sodium Chloride",
"NonProprietaryName": "Midazolam In 0.8% Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218454",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "MIDAZOLAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251015",
"SamplePackage": "N",
"IndicationAndUsage": "Midazolam in Sodium Chloride Injection is indicated: Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting.",
"Description": "Midazolam in 0.8% Sodium Chloride Injection is a benzodiazepine available as a sterile, preservative-free, nonpyrogenic solution of midazolam and sodium chloride in water for injection for intravenous use. Each single-dose bag of Midazolam in Sodium Chloride Injection contains either 50 mg/50 mL (1 mg/mL) or 100 mg/100 mL (1 mg/mL) of midazolam and 8 mg/mL of sodium chloride in water for injection. Midazolam in 0.8% Sodium Chloride Injection may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH is 3.0 – 4.0. Midazolam is a white to light yellow crystalline compound, insoluble in water, freely soluble in ethanol, soluble in methanol. Chemically, midazolam is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a] [1,4]benzodiazepine. Midazolam has the empirical formula C18H13ClFN3, a calculated molecular weight of 325.8 and the following structural formula."
},
{
"NDCCode": "0273-8002-01",
"PackageDescription": "10 mL in 1 CUP (0273-8002-01) ",
"NDC11Code": "00273-8002-01",
"ProductNDC": "0273-8002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nafrinse Unit Dose Mint Flavor",
"NonProprietaryName": "Sodium Fluoride And Hydrofluoric Acid",
"DosageFormName": "SOLUTION",
"RouteName": "DENTAL",
"StartMarketingDate": "20170824",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Young Dental Manufacturing Co 1, LLC.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170828",
"SamplePackage": "N"
},
{
"NDCCode": "11532-8002-1",
"PackageDescription": "10 CARTON in 1 BOX (11532-8002-1) > 100 VIAL, MULTI-DOSE in 1 CARTON > .5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "11532-8002-01",
"ProductNDC": "11532-8002",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Peginesatide Injection",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20120221",
"EndMarketingDate": "20150515",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Takeda Pharmaceutical Co LTD",
"SubstanceName": "PEGINESATIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/.5mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20150515"
},
{
"NDCCode": "50090-8002-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-8002-0) ",
"NDC11Code": "50090-8002-00",
"ProductNDC": "50090-8002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Letrozole",
"NonProprietaryName": "Letrozole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200161",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LETROZOLE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260624",
"SamplePackage": "N",
"IndicationAndUsage": "Letrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer (1.1), 2 Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy (1.2), 3 First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer (1.3).",
"Description": "Letrozole tablets for oral administration contain 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1-ylmethylene)dibenzonitrile, and its structural formula is. Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31, empirical formula C17H11N5, and a melting range of 184°C to 185°C. Letrozole tablets are available as 2.5 mg tablets for oral administration."
},
{
"NDCCode": "63083-1001-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1001-2) ",
"NDC11Code": "63083-1001-02",
"ProductNDC": "63083-1001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pets",
"ProprietaryNameSuffix": "1001",
"NonProprietaryName": "Pets",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAMELUS BACTRIANUS HAIR; FELIS CATUS HAIR; BOVINE TYPE I COLLAGEN (SKIN); CANIS LUPUS FAMILIARIS HAIR; GALLUS GALLUS FEATHER; BLUEGILL; CAPRA HIRCUS HAIR; CAVIA PORCELLUS WHOLE; SUS SCROFA HAIR; HORSE; RABBIT; SHEEP WOOL",
"StrengthNumber": "6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dander [CS], Dietary Proteins [CS], Dietary Proteins [CS], Feathers [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Meat Proteins [EXT], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Feather Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1002-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1002-2) ",
"NDC11Code": "63083-1002-02",
"ProductNDC": "63083-1002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Biting Insect Mix",
"ProprietaryNameSuffix": "1002",
"NonProprietaryName": "Biting Insect Mix",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; SOLENOPSIS INVICTA; APIS CERANA WHOLE; PERIPLANETA AUSTRALASIAE; TABANUS NIGROVITTATUS; CTENOCEPHALIDES CANIS; MUSCA DOMESTICA; CULEX PIPIENS; BOMBYX MORI WHOLE; LATRODECTUS MACTANS; BORRELIA BURGDORFERI; POLISTES FUSCATUS WHOLE",
"StrengthNumber": "6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Ant Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1003-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1003-2) ",
"NDC11Code": "63083-1003-02",
"ProductNDC": "63083-1003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Caffeine Mix",
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"NonProprietaryName": "Caffeine Mix",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAFFEINE; COCOA; COFFEE BEAN; HIGH FRUCTOSE CORN SYRUP; TEA LEAF",
"StrengthNumber": "6; 6; 12; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
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"SamplePackage": "N"
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{
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"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1004-2) ",
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"ProductTypeName": "HUMAN OTC DRUG",
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"NonProprietaryName": "Dairy Mix",
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"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; BLUE TILAPIA WHOLE; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED; COW MILK FAT; CASEIN, STREPTOCOCCUS THERMOPHILUS CULTURED, PROPIONIBACTERIUM FREUDENREICHII SUBSP. SHERMANII CULTURED, AGED; WHEY; SWISS CHARD; COW MILK; GOAT MILK; HUMAN MILK",
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"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
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{
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"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1008-2) ",
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"ProductTypeName": "HUMAN OTC DRUG",
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"NonProprietaryName": "Flowers",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; SYMPHYOTRICHUM OBLONGIFOLIUM WHOLE; CAMELLIA CHEKIANGOLEOSA SEED OIL; DIANTHUS CARYOPHYLLUS WHOLE; KALIMERIS INDICA WHOLE; NARCISSUS POETICUS WHOLE; TOWNSENDIA EXSCAPA WHOLE; GARDENIA JASMINOIDES FRUIT; GENTIANA LUTEA ROOT; GLADIOLUS COMMUNIS WHOLE; LONICERA CANADENSIS WHOLE; C12-17 ALKANE; DELPHINIUM AJACIS SEED; DIANTHUS SUPERBUS FLOWERING TOP; HEDYCHIUM FLAVESCENS WHOLE; LUPINUS ELEGANS WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; NERIUM OLEANDER WHOLE; VIOLA TRICOLOR WHOLE; PAEONIA X SUFFRUTICOSA SEED; RUELLIA SIMPLEX WHOLE; ESCHSCHOLZIA CALIFORNICA FLOWERING TOP; SEDUM ROSEUM WHOLE; ANTIRRHINUM MAJUS LEAF; LIRIODENDRON TULIPIFERA WHOLE",
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{
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"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAPSICUM; EGGPLANT; PHYSALIS VIRGINIANA WHOLE; CULTIVATED MUSHROOM; MUSTARD GREENS; PEPPERS; POTATO; TOBACCO LEAF; TOMATO",
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"Status": "Active",
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{
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"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1012-2) ",
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"ProductNDC": "63083-1012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nut Mix",
"ProprietaryNameSuffix": "1012",
"NonProprietaryName": "Nut Mix",
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"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
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"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
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{
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"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
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"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
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"LastUpdate": "2026-01-09",
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"SamplePackage": "N"
},
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"NDCCode": "63083-1015-2",
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"ProductTypeName": "HUMAN OTC DRUG",
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"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "ANHYDROUS LACTOSE; ASPARTAME; BEEF LIVER; CORTICOTROPIN; DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; HISTAMINE DIHYDROCHLORIDE; HONEY; LIGHT BROWN SUGAR; MALTODEXTRIN; MALTOSE ANHYDROUS; MOLASSES; SACCHARIN; SUCRALOSE; SUCROSE; SUCROSE STEARATE; SUS SCROFA ADRENAL GLAND",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]",
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"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of gas, bloating, diarrhea, and itching of the nose or throat due to sensitivity to sugars and sweeteners.*."
},
{
"NDCCode": "63083-1016-2",
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"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"NDCCode": "63083-1017-2",
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"ProductNDC": "63083-1017",
"ProductTypeName": "HUMAN OTC DRUG",
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"ProprietaryNameSuffix": "1017",
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"RouteName": "ORAL",
"StartMarketingDate": "19840815",
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"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; ACACIA; POPULUS TREMULOIDES POLLEN; BAY LEAF; SAMBUCUS NIGRA FLOWER; EUCALYPTUS GUM; FIG; DIANTHUS SUPERBUS FLOWERING TOP; MAGNOLIA X ALBA WHOLE; PROSOPIS CINERARIA WOOD; NERIUM OLEANDER WHOLE; GREEN OLIVE; BLACK PEPPER; LIGUSTRUM LUCIDUM SEED; SYMPHORICARPOS ALBUS FRUIT; LIRIODENDRON TULIPIFERA WHOLE; SALIX LUTEA POLLEN",
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<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60681-8002-1</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (60681-8002-1) > 2 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>60681-8002-01</NDC11Code>
<ProductNDC>60681-8002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pleo Citro</ProprietaryName>
<NonProprietaryName>Citric Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970319</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sanum Kehlbeck GmbH & Co. KG</LabelerName>
<SubstanceName>CITRIC ACID; CITRIC ACID; CITRIC ACID</SubstanceName>
<StrengthNumber>10; 30; 200</StrengthNumber>
<StrengthUnit>[HP_X]/2mL; [HP_X]/2mL; [HP_X]/2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For symptoms of allergies and the common cold.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60681-8002-2</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 CARTON (60681-8002-2) > 2 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>60681-8002-02</NDC11Code>
<ProductNDC>60681-8002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pleo Citro</ProprietaryName>
<NonProprietaryName>Citric Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970319</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sanum Kehlbeck GmbH & Co. KG</LabelerName>
<SubstanceName>CITRIC ACID; CITRIC ACID; CITRIC ACID</SubstanceName>
<StrengthNumber>10; 30; 200</StrengthNumber>
<StrengthUnit>[HP_X]/2mL; [HP_X]/2mL; [HP_X]/2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For symptoms of allergies and the common cold.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62112-8002-2</NDCCode>
<PackageDescription>25000 CAPSULE, GELATIN COATED in 1 BOX (62112-8002-2)</PackageDescription>
<NDC11Code>62112-8002-02</NDC11Code>
<ProductNDC>62112-8002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<StartMarketingDate>19980301</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Intergel Pharmaceuticals inc</LabelerName>
<SubstanceName>DIMETHICONE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>118.44; 6.56</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68210-8002-2</NDCCode>
<PackageDescription>44 BLISTER PACK in 1 BOX (68210-8002-2) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68210-8002-02</NDC11Code>
<ProductNDC>68210-8002</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Spirit Pharmaceuticals LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JUN-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>69096-8002-2</NDCCode>
<PackageDescription>150 g in 1 CARTON (69096-8002-2) </PackageDescription>
<NDC11Code>69096-8002-02</NDC11Code>
<ProductNDC>69096-8002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Linea Jose Ignacio Sunscreen Broad Spectrum Spf 30 With Zinc</ProprietaryName>
<NonProprietaryName>Sunscreen Broad Spectrum Sfp 30 With Zinc</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Linea Jose Ignacio LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>g/150g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72326-8002-2</NDCCode>
<PackageDescription>120 g in 1 TUBE (72326-8002-2) </PackageDescription>
<NDC11Code>72326-8002-02</NDC11Code>
<ProductNDC>72326-8002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Plak Smacker Anti Cavity Fluoride</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20180527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>YOUNG PS ACQUISITION, LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76344-8002-2</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (76344-8002-2) > 50 g in 1 TUBE (76344-8002-1) </PackageDescription>
<NDC11Code>76344-8002-02</NDC11Code>
<ProductNDC>76344-8002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Post Rays Uv Protect Sun Block</ProprietaryName>
<NonProprietaryName>Zinc Oxide,octinoxate, Octisalate,titamium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Humex,Inc</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>6.8; 4.5; 4.0014; 5.006</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0264-8002-32</NDCCode>
<PackageDescription>30 CONTAINER in 1 CASE (0264-8002-32) / 100 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-8002-32</NDC11Code>
<ProductNDC>0264-8002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midazolam In 0.8% Sodium Chloride</ProprietaryName>
<NonProprietaryName>Midazolam In 0.8% Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218454</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>MIDAZOLAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midazolam in Sodium Chloride Injection is indicated: Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting.</IndicationAndUsage>
<Description>Midazolam in 0.8% Sodium Chloride Injection is a benzodiazepine available as a sterile, preservative-free, nonpyrogenic solution of midazolam and sodium chloride in water for injection for intravenous use. Each single-dose bag of Midazolam in Sodium Chloride Injection contains either 50 mg/50 mL (1 mg/mL) or 100 mg/100 mL (1 mg/mL) of midazolam and 8 mg/mL of sodium chloride in water for injection. Midazolam in 0.8% Sodium Chloride Injection may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH is 3.0 – 4.0. Midazolam is a white to light yellow crystalline compound, insoluble in water, freely soluble in ethanol, soluble in methanol. Chemically, midazolam is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a] [1,4]benzodiazepine. Midazolam has the empirical formula C18H13ClFN3, a calculated molecular weight of 325.8 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0273-8002-01</NDCCode>
<PackageDescription>10 mL in 1 CUP (0273-8002-01) </PackageDescription>
<NDC11Code>00273-8002-01</NDC11Code>
<ProductNDC>0273-8002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nafrinse Unit Dose Mint Flavor</ProprietaryName>
<NonProprietaryName>Sodium Fluoride And Hydrofluoric Acid</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20170824</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Young Dental Manufacturing Co 1, LLC.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11532-8002-1</NDCCode>
<PackageDescription>10 CARTON in 1 BOX (11532-8002-1) > 100 VIAL, MULTI-DOSE in 1 CARTON > .5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>11532-8002-01</NDC11Code>
<ProductNDC>11532-8002</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Peginesatide Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20120221</StartMarketingDate>
<EndMarketingDate>20150515</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Takeda Pharmaceutical Co LTD</LabelerName>
<SubstanceName>PEGINESATIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20150515</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-8002-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-8002-0) </PackageDescription>
<NDC11Code>50090-8002-00</NDC11Code>
<ProductNDC>50090-8002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Letrozole</ProprietaryName>
<NonProprietaryName>Letrozole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200161</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LETROZOLE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Letrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer (1.1), 2 Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy (1.2), 3 First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer (1.3).</IndicationAndUsage>
<Description>Letrozole tablets for oral administration contain 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1-ylmethylene)dibenzonitrile, and its structural formula is. Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31, empirical formula C17H11N5, and a melting range of 184°C to 185°C. Letrozole tablets are available as 2.5 mg tablets for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>63083-1001-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1001-2) </PackageDescription>
<NDC11Code>63083-1001-02</NDC11Code>
<ProductNDC>63083-1001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pets</ProprietaryName>
<ProprietaryNameSuffix>1001</ProprietaryNameSuffix>
<NonProprietaryName>Pets</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAMELUS BACTRIANUS HAIR; FELIS CATUS HAIR; BOVINE TYPE I COLLAGEN (SKIN); CANIS LUPUS FAMILIARIS HAIR; GALLUS GALLUS FEATHER; BLUEGILL; CAPRA HIRCUS HAIR; CAVIA PORCELLUS WHOLE; SUS SCROFA HAIR; HORSE; RABBIT; SHEEP WOOL</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dander [CS], Dietary Proteins [CS], Dietary Proteins [CS], Feathers [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Meat Proteins [EXT], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Feather Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1002-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1002-2) </PackageDescription>
<NDC11Code>63083-1002-02</NDC11Code>
<ProductNDC>63083-1002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Biting Insect Mix</ProprietaryName>
<ProprietaryNameSuffix>1002</ProprietaryNameSuffix>
<NonProprietaryName>Biting Insect Mix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; SOLENOPSIS INVICTA; APIS CERANA WHOLE; PERIPLANETA AUSTRALASIAE; TABANUS NIGROVITTATUS; CTENOCEPHALIDES CANIS; MUSCA DOMESTICA; CULEX PIPIENS; BOMBYX MORI WHOLE; LATRODECTUS MACTANS; BORRELIA BURGDORFERI; POLISTES FUSCATUS WHOLE</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Ant Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1003-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1003-2) </PackageDescription>
<NDC11Code>63083-1003-02</NDC11Code>
<ProductNDC>63083-1003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Caffeine Mix</ProprietaryName>
<ProprietaryNameSuffix>1003</ProprietaryNameSuffix>
<NonProprietaryName>Caffeine Mix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAFFEINE; COCOA; COFFEE BEAN; HIGH FRUCTOSE CORN SYRUP; TEA LEAF</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Meat Proteins [EXT], Methylxanthine [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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