{
"NDC": [
{
"NDCCode": "63083-5019-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-5019-2) ",
"NDC11Code": "63083-5019-02",
"ProductNDC": "63083-5019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Male Endocrine Axis Drops",
"ProprietaryNameSuffix": "5019",
"NonProprietaryName": "Male Endocrine Axis Drops",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "POPULUS TREMULOIDES BARK; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; PYGEUM; SMILAX ORNATA ROOT; ZINC; TURNERA DIFFUSA LEAFY TWIG; SUS SCROFA ADRENAL GLAND; FERRIC CATION; BOS TAURUS TESTICLE; BOS TAURUS PITUITARY GLAND, POSTERIOR; BOS TAURUS PROSTATE GLAND; SELENIUM",
"StrengthNumber": "1; 1; 2; 3; 3; 3; 4; 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",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "0591-5019-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0591-5019-02) / 5 mL in 1 SYRINGE, GLASS (0591-5019-11) ",
"NDC11Code": "00591-5019-02",
"ProductNDC": "0591-5019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fulvestrant",
"NonProprietaryName": "Fulvestrant",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20190822",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210063",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "FULVESTRANT",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190822",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "Monotherapy. Fulvestrant Injection is indicated for the treatment of: : 1 Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or, 2 HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.",
"Description": "Fulvestrant Injection for intramuscular administration is an estrogen receptor antagonist. The chemical name is 7-alpha-[9-(4,4,5,5,5-penta fluoropentylsulphinyl) nonyl]estra-1,3,5-(10)-triene-3,17-beta-diol. The molecular formula is C32H47F5O3S and its structural formula is. Fulvestrant, USP is a white powder with a molecular weight of 606.77. The sterile injection solution is a clear, colorless to yellow viscous liquid supplied in two 5 mL single-dose prefilled syringes each containing 250 mg/5 mL of fulvestrant, USP for intramuscular administration. Fulvestrant Injection contains the following inactive ingredients in each 5 mL syringe: benzyl alcohol 500 mg (10% w/v) and dehydrated alcohol 500 mg (10% w/v); castor oil 3000 mg (60% w/v), medium chain triglycerides q.s. to 5 mL (10.8% w/v), and nitrogen q.s."
},
{
"NDCCode": "11822-5019-2",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5019-2) ",
"NDC11Code": "11822-5019-02",
"ProductNDC": "11822-5019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211544",
"LabelerName": "RITE AID",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": " temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever."
},
{
"NDCCode": "57955-5019-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-5019-2)",
"NDC11Code": "57955-5019-02",
"ProductNDC": "57955-5019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Constipation Relief",
"NonProprietaryName": "Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131004",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"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",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms of constipation: irregularity, hard, dry stools, great straining, rumbling and bloated bowels, mucus in stools, associated headache."
},
{
"NDCCode": "62670-5019-2",
"PackageDescription": "56 mL in 1 BOTTLE, PUMP (62670-5019-2)",
"NDC11Code": "62670-5019-02",
"ProductNDC": "62670-5019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Coconut Lime Verbena",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160105",
"EndMarketingDate": "20160705",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "72",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "50090-5019-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-5019-0) ",
"NDC11Code": "50090-5019-00",
"ProductNDC": "50090-5019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077691",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200424",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia. .",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red."
},
{
"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",
"ProprietaryNameSuffix": "1003",
"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",
"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]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1004-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1004-2) ",
"NDC11Code": "63083-1004-02",
"ProductNDC": "63083-1004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dairy Mix",
"ProprietaryNameSuffix": "1004",
"NonProprietaryName": "Dairy 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; 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",
"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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [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], Milk Proteins [CS], Milk Proteins [CS], Milk Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1008-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1008-2) ",
"NDC11Code": "63083-1008-02",
"ProductNDC": "63083-1008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flowers",
"ProprietaryNameSuffix": "1008",
"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",
"StrengthNumber": "6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 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; [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]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1011-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1011-2) ",
"NDC11Code": "63083-1011-02",
"ProductNDC": "63083-1011",
"ProductTypeName": "HUMAN OTC DRUG",
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"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; BEEF LIVER; HISTAMINE DIHYDROCHLORIDE; FELIS CATUS HAIR; HOUSE DUST; SYMPHYOTRICHUM OBLONGIFOLIUM WHOLE; MEDICAGO SATIVA WHOLE; FRAXINUS LATIFOLIA WHOLE",
"StrengthNumber": "6; 6; 6; 12; 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",
"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dander [CS], Dietary Proteins [CS], House Dust [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized House Dust Allergenic Extract [EPC], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1026-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1026-2) ",
"NDC11Code": "63083-1026-02",
"ProductNDC": "63083-1026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eastern Trees",
"ProprietaryNameSuffix": "1026",
"NonProprietaryName": "Eastern Trees",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "FRAXINUS LATIFOLIA WHOLE; MILLETTIA PINNATA WHOLE; BETULA OCCIDENTALIS POLLEN; ELM; CARYA LACINIOSA BARK; ACER PENSYLVANICUM WHOLE; QUERCUS KELLOGGII POLLEN; LIRIODENDRON TULIPIFERA WHOLE; LIQUIDAMBAR STYRACIFLUA RESIN; SYMPHORICARPOS ALBUS FRUIT",
"StrengthNumber": "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",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1027-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1027-2) ",
"NDC11Code": "63083-1027-02",
"ProductNDC": "63083-1027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gluten Mix",
"ProprietaryNameSuffix": "1027",
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"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "WHEAT GLUTEN",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1028-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1028-2) ",
"NDC11Code": "63083-1028-02",
"ProductNDC": "63083-1028",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wheat Mix",
"ProprietaryNameSuffix": "1028",
"NonProprietaryName": "Wheat Mix",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "WHEAT",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of gas, bloating, diarrhea, and itching of the nose or throat due to sensitivity to wheat.*."
},
{
"NDCCode": "63083-2001-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-2001-2) ",
"NDC11Code": "63083-2001-02",
"ProductNDC": "63083-2001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acne Drops",
"ProprietaryNameSuffix": "2001",
"NonProprietaryName": "Acne Drops",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "ARCTIUM LAPPA ROOT OIL; BERBERIS AQUIFOLIUM ROOT BARK; CENTELLA ASIATICA LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; SULFUR; ANTIMONY TRISULFIDE; POTASSIUM BROMIDE; SODIUM CHLORIDE; CARBO ANIMALIS",
"StrengthNumber": "3; 3; 3; 4; 6; 6; 6; 6; 8; 12; 12; 15",
"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",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-2002-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-2002-2) ",
"NDC11Code": "63083-2002-02",
"ProductNDC": "63083-2002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Melancholy Drops",
"ProprietaryNameSuffix": "2002",
"NonProprietaryName": "Melancholy Drops",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "LITHIUM CARBONATE; BOS TAURUS BRAIN; SUS SCROFA PINEAL GLAND; GOLD; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; SEPIA OFFICINALIS JUICE; SEROTONIN",
"StrengthNumber": "6; 6; 6; 12; 12; 12; 12; 16",
"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",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Mood Stabilizer [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>63083-5019-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-5019-2) </PackageDescription>
<NDC11Code>63083-5019-02</NDC11Code>
<ProductNDC>63083-5019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Male Endocrine Axis Drops</ProprietaryName>
<ProprietaryNameSuffix>5019</ProprietaryNameSuffix>
<NonProprietaryName>Male Endocrine Axis Drops</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>POPULUS TREMULOIDES BARK; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; PYGEUM; SMILAX ORNATA ROOT; ZINC; TURNERA DIFFUSA LEAFY TWIG; SUS SCROFA ADRENAL GLAND; FERRIC CATION; BOS TAURUS TESTICLE; BOS TAURUS PITUITARY GLAND, POSTERIOR; BOS TAURUS PROSTATE GLAND; SELENIUM</SubstanceName>
<StrengthNumber>1; 1; 2; 3; 3; 3; 4; 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</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</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>0591-5019-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0591-5019-02) / 5 mL in 1 SYRINGE, GLASS (0591-5019-11) </PackageDescription>
<NDC11Code>00591-5019-02</NDC11Code>
<ProductNDC>0591-5019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fulvestrant</ProprietaryName>
<NonProprietaryName>Fulvestrant</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20190822</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210063</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>FULVESTRANT</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190822</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Monotherapy. Fulvestrant Injection is indicated for the treatment of: : 1 Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or, 2 HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.</IndicationAndUsage>
<Description>Fulvestrant Injection for intramuscular administration is an estrogen receptor antagonist. The chemical name is 7-alpha-[9-(4,4,5,5,5-penta fluoropentylsulphinyl) nonyl]estra-1,3,5-(10)-triene-3,17-beta-diol. The molecular formula is C32H47F5O3S and its structural formula is. Fulvestrant, USP is a white powder with a molecular weight of 606.77. The sterile injection solution is a clear, colorless to yellow viscous liquid supplied in two 5 mL single-dose prefilled syringes each containing 250 mg/5 mL of fulvestrant, USP for intramuscular administration. Fulvestrant Injection contains the following inactive ingredients in each 5 mL syringe: benzyl alcohol 500 mg (10% w/v) and dehydrated alcohol 500 mg (10% w/v); castor oil 3000 mg (60% w/v), medium chain triglycerides q.s. to 5 mL (10.8% w/v), and nitrogen q.s.</Description>
</NDC>
<NDC>
<NDCCode>11822-5019-2</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5019-2) </PackageDescription>
<NDC11Code>11822-5019-02</NDC11Code>
<ProductNDC>11822-5019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211544</ApplicationNumber>
<LabelerName>RITE AID</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-5019-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-5019-2)</PackageDescription>
<NDC11Code>57955-5019-02</NDC11Code>
<ProductNDC>57955-5019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Constipation Relief</ProprietaryName>
<NonProprietaryName>Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131004</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</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</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms of constipation: irregularity, hard, dry stools, great straining, rumbling and bloated bowels, mucus in stools, associated headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62670-5019-2</NDCCode>
<PackageDescription>56 mL in 1 BOTTLE, PUMP (62670-5019-2)</PackageDescription>
<NDC11Code>62670-5019-02</NDC11Code>
<ProductNDC>62670-5019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Coconut Lime Verbena</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160105</StartMarketingDate>
<EndMarketingDate>20160705</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>72</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>50090-5019-0</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-5019-0) </PackageDescription>
<NDC11Code>50090-5019-00</NDC11Code>
<ProductNDC>50090-5019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077691</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia. .</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</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>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<SamplePackage>N</SamplePackage>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; FRAXINUS LATIFOLIA WHOLE; POPULUS TREMULOIDES POLLEN; SUAEDA MARITIMA FLOWERING TOP; MILLETTIA PINNATA WHOLE; CYNODON DACTYLON WHOLE; BETULA OCCIDENTALIS POLLEN; ACER NEGUNDO ROOT BARK; BASSIA SCOPARIA FRUIT; XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN; POPULUS FREMONTII POLLEN; ELM; PLANTAGO LANCEOLATA LEAF; MEDICAGO SATIVA WHOLE; CARYA LACINIOSA BARK; CHENOPODIUM ALBUM POLLEN; IVA ANGUSTIFOLIA WHOLE; WHITE MULBERRY; NEUROTENSIN; QUERCUS KELLOGGII POLLEN; AMARANTHUS HYBRIDUS LEAF; PINUS PONDEROSA POLLEN; LIGUSTRUM LUCIDUM SEED; AMBROSIA ARTEMISIIFOLIA WHOLE; RUMEX CRISPUS ROOT; SAGE; SYMPHORICARPOS ALBUS FRUIT; ENGLISH WALNUT</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 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; [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], 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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], 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], 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], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant 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], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Nut Proteins [EXT], Plant Proteins [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]</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>63083-1022-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1022-2) </PackageDescription>
<NDC11Code>63083-1022-02</NDC11Code>
<ProductNDC>63083-1022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tropical</ProprietaryName>
<ProprietaryNameSuffix>1022</ProprietaryNameSuffix>
<NonProprietaryName>Tropical</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>ACACIA; AMARANTHUS HYBRIDUS LEAF; AMBROSIA ARTEMISIIFOLIA WHOLE; ATRIPLEX POLYCARPA WHOLE; BEEF LIVER; CORTICOTROPIN; CYNODON DACTYLON WHOLE; EUCALYPTUS GUM; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS SCOPULORUM POLLEN; OLEA EUROPAEA FLOWER; PLANTAGO LANCEOLATA LEAF; POA PRATENSIS TOP; SUS SCROFA ADRENAL GLAND; SYAGRUS ROMANZOFFIANA WHOLE; WHITE MULBERRY; XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 12; 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; [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], Dietary Proteins [CS], 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], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Plant Proteins [CS], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to sensitivity to common allergens in the tropics and Hawaii.*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63083-1023-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1023-2) </PackageDescription>
<NDC11Code>63083-1023-02</NDC11Code>
<ProductNDC>63083-1023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smoke Mix</ProprietaryName>
<ProprietaryNameSuffix>1023</ProprietaryNameSuffix>
<NonProprietaryName>Smoke 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; ACTIVATED CHARCOAL; ALOE SPICATA WHOLE; TOBACCO SMOKE; LIQUID PETROLEUM; NATURAL LATEX RUBBER; GUTTA PERCHA; TABTOXIN</SubstanceName>
<StrengthNumber>6; 6; 12; 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</StrengthUnit>
<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]</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>63083-1024-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1024-2) </PackageDescription>
<NDC11Code>63083-1024-02</NDC11Code>
<ProductNDC>63083-1024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Southeast Regional</ProprietaryName>
<ProprietaryNameSuffix>1024</ProprietaryNameSuffix>
<NonProprietaryName>Southeast Regional</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; ACACIA; PLATANUS OCCIDENTALIS BARK; MILLETTIA PINNATA WHOLE; CYNODON DACTYLON WHOLE; BETULA OCCIDENTALIS POLLEN; XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; ELM; PLANTAGO LANCEOLATA LEAF; SCHINUS TEREBINTHIFOLIA POLLEN; MEDICAGO SATIVA WHOLE; CHENOPODIUM ALBUM POLLEN; IVA ANGUSTIFOLIA WHOLE; MELALEUCA VIRIDIFLORA WHOLE; JUNIPERUS SCOPULORUM POLLEN; WHITE MULBERRY; QUERCUS KELLOGGII POLLEN; AMARANTHUS HYBRIDUS LEAF; PINUS PONDEROSA POLLEN; AMBROSIA ARTEMISIIFOLIA WHOLE; RUMEX CRISPUS ROOT; SAGE; STENOTAPHRUM SECUNDATUM WHOLE; ENGLISH WALNUT; AMARANTHUS TUBERCULATUS POLLEN; FRAXINUS AMERICANA BARK</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 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; [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], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [Chemical/Ingredient], 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], 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], Dietary Proteins [CS], 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 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], 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 Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant 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], 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], Nut Proteins [EXT], Plant Proteins [CS], Plant Proteins [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [Chemical/Ingredient]</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>63083-1025-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1025-2) </PackageDescription>
<NDC11Code>63083-1025-02</NDC11Code>
<ProductNDC>63083-1025</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Airborne</ProprietaryName>
<ProprietaryNameSuffix>1025</ProprietaryNameSuffix>
<NonProprietaryName>Airborne</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; BEEF LIVER; HISTAMINE DIHYDROCHLORIDE; FELIS CATUS HAIR; HOUSE DUST; SYMPHYOTRICHUM OBLONGIFOLIUM WHOLE; MEDICAGO SATIVA WHOLE; FRAXINUS LATIFOLIA WHOLE</SubstanceName>
<StrengthNumber>6; 6; 6; 12; 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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dander [CS], Dietary Proteins [CS], House Dust [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized House Dust Allergenic Extract [EPC], Salivary Proteins and Peptides [CS], Standardized Animal Hair 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>63083-1026-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1026-2) </PackageDescription>
<NDC11Code>63083-1026-02</NDC11Code>
<ProductNDC>63083-1026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eastern Trees</ProprietaryName>
<ProprietaryNameSuffix>1026</ProprietaryNameSuffix>
<NonProprietaryName>Eastern Trees</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>FRAXINUS LATIFOLIA WHOLE; MILLETTIA PINNATA WHOLE; BETULA OCCIDENTALIS POLLEN; ELM; CARYA LACINIOSA BARK; ACER PENSYLVANICUM WHOLE; QUERCUS KELLOGGII POLLEN; LIRIODENDRON TULIPIFERA WHOLE; LIQUIDAMBAR STYRACIFLUA RESIN; SYMPHORICARPOS ALBUS FRUIT</SubstanceName>
<StrengthNumber>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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</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>63083-1027-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1027-2) </PackageDescription>
<NDC11Code>63083-1027-02</NDC11Code>
<ProductNDC>63083-1027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gluten Mix</ProprietaryName>
<ProprietaryNameSuffix>1027</ProprietaryNameSuffix>
<NonProprietaryName>Gluten Mix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>WHEAT GLUTEN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food 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>63083-1028-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1028-2) </PackageDescription>
<NDC11Code>63083-1028-02</NDC11Code>
<ProductNDC>63083-1028</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wheat Mix</ProprietaryName>
<ProprietaryNameSuffix>1028</ProprietaryNameSuffix>
<NonProprietaryName>Wheat Mix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>WHEAT</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of gas, bloating, diarrhea, and itching of the nose or throat due to sensitivity to wheat.*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63083-2001-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-2001-2) </PackageDescription>
<NDC11Code>63083-2001-02</NDC11Code>
<ProductNDC>63083-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acne Drops</ProprietaryName>
<ProprietaryNameSuffix>2001</ProprietaryNameSuffix>
<NonProprietaryName>Acne Drops</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>ARCTIUM LAPPA ROOT OIL; BERBERIS AQUIFOLIUM ROOT BARK; CENTELLA ASIATICA LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; SULFUR; ANTIMONY TRISULFIDE; POTASSIUM BROMIDE; SODIUM CHLORIDE; CARBO ANIMALIS</SubstanceName>
<StrengthNumber>3; 3; 3; 4; 6; 6; 6; 6; 8; 12; 12; 15</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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</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>63083-2002-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-2002-2) </PackageDescription>
<NDC11Code>63083-2002-02</NDC11Code>
<ProductNDC>63083-2002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Melancholy Drops</ProprietaryName>
<ProprietaryNameSuffix>2002</ProprietaryNameSuffix>
<NonProprietaryName>Melancholy Drops</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>LITHIUM CARBONATE; BOS TAURUS BRAIN; SUS SCROFA PINEAL GLAND; GOLD; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; SEPIA OFFICINALIS JUICE; SEROTONIN</SubstanceName>
<StrengthNumber>6; 6; 6; 12; 12; 12; 12; 16</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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Mood Stabilizer [EPC], Standardized Chemical Allergen [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>
</NDCList>