{
"NDC": [
{
"NDCCode": "83014-0100-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0100-1) ",
"NDC11Code": "83014-0100-01",
"ProductNDC": "83014-0100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus - Glp 1 Booster",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Berberis Vulgaris, Cinnamomum, Fucus Vesiculosus, Lecithin (derived From Egg), Trigonella Foenum-graecum, Panax Ginseng, Capsicum Annuum, Curcuma Longa, Galium Aparine, Hepar Suis, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Pancreas Suis, Phytolacca Decandra, Small Intestine (suis), Pituitarum Posterium (bovine), Thyroidinum (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20260129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; BERBERIS VULGARIS ROOT BARK; CINNAMON; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; FENUGREEK SEED; ASIAN GINSENG; CAPSICUM; TURMERIC; GALIUM APARINE WHOLE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; SUS SCROFA PANCREAS; PHYTOLACCA AMERICANA ROOT; SUS SCROFA INTESTINAL MUCOSA; BOS TAURUS PITUITARY GLAND, POSTERIOR; THYROID, BOVINE; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS",
"StrengthNumber": "2; 3; 3; 3; 3; 3; 3; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 9; 9; 9; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260129",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating, helps with metabolic tendencies to gain weight, cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides support for the body's production of GLP 1.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0001-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0001-1) ",
"NDC11Code": "83014-0001-01",
"ProductNDC": "83014-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Female Balance",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Caulophyllum Thalictroides, Cimicifuga Racemosa, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Rubus Idaeus, Thyroidinum (bovine), Pituitarum Posterium Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Hepar Sulphuris Calcareum, Oxytocin, Progesterone",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230321",
"EndMarketingDate": "20290214",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM SULFIDE; OXYTOCIN; PROGESTERONE",
"StrengthNumber": "2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 12; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Oxytocic [EPC], Oxytocin [CS], Plant Proteins [CS], Progesterone [CS], Progesterone [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230321",
"EndMarketingDatePackage": "20290214",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides female hormonogenic balance support. †. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0002-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0002-1) ",
"NDC11Code": "83014-0002-01",
"ProductNDC": "83014-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Adrenal",
"NonProprietaryName": "Glycyrrhiza Glabra, Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Aralia Quinquefolia, Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Glandula Suprarenalis (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Adrenocorticotrophin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230321",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "GLYCYRRHIZA GLABRA; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; AMERICAN GINSENG; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS ADRENAL GLAND; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CORTICOTROPIN",
"StrengthNumber": "1; 2; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 15",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230321",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant, to control empty feeling in stomach otherwise relieved by eating, helps with metabolic tendencies to gain weight, cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides adrenal support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0003-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0003-1) ",
"NDC11Code": "83014-0003-01",
"ProductNDC": "83014-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Male Balance",
"NonProprietaryName": "Agnus Castus, Foeniculum Vulgare, Ammonium Bromatum, Caladium Seguinum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Selenium Metallicum, Adrenalinum, Phosphorus, Orchitinum (bovine), Onosmodium Virginianum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230310",
"EndMarketingDate": "20280614",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "CHASTE TREE FRUIT; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; DIEFFENBACHIA SEGUINE WHOLE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SELENIUM; EPINEPHRINE; PHOSPHORUS; BOS TAURUS TESTICLE; ONOSMODIUM VIRGINIANUM",
"StrengthNumber": "2; 2; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 9; 12; 12; 16; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230310",
"EndMarketingDatePackage": "20280614",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides male hormonogenic support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0004-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0004-1) ",
"NDC11Code": "83014-0004-01",
"ProductNDC": "83014-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Pituitarum Posterium (bovine), Thyroidinum (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230216",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; BOS TAURUS PITUITARY GLAND, POSTERIOR; THYROID, BOVINE; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS",
"StrengthNumber": "2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 8; 6; 9; 9; 9; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230216",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue and resets the hypothalamus.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0005-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0005-1) ",
"NDC11Code": "83014-0005-01",
"ProductNDC": "83014-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Immune Support",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Petroselinum Sativum, Capsicum Annuum, Galium Aparine, Hydrastis Canadensis, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Thymus (bovine Thymus Gland), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; PETROSELINUM CRISPUM WHOLE; CAPSICUM; GALIUM APARINE WHOLE; GOLDENSEAL; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS THYMUS; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS",
"StrengthNumber": "2; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230217",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides immune support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0006-1",
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"NDC11Code": "83014-0006-01",
"ProductNDC": "83014-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Thyroid",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin, Rutinic Acid, Iodium, Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Spongia Tosta, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Lapis Albus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230822",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPRIC ACID; IODINE; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM HEXAFLUOROSILICATE",
"StrengthNumber": "2; 3; 3; 3; 3; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 15",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230822",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides thyroid support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0007-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0007-1) ",
"NDC11Code": "83014-0007-01",
"ProductNDC": "83014-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Male Balance",
"NonProprietaryName": "Agnus Castus, Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Selenium Metallicum, Adrenalinum, Phosphorus, Orchitinum (bovine), Caladium Seguinum, Onosmodium Virginianum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20231030",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "CHASTE TREE FRUIT; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SELENIUM; EPINEPHRINE; PHOSPHORUS; BOS TAURUS TESTICLE; DIEFFENBACHIA SEGUINE WHOLE; ONOSMODIUM VIRGINIANUM",
"StrengthNumber": "2; 2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 9; 12; 12; 16; 18; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231030",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides male hormonogenic support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0008-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0008-1) ",
"NDC11Code": "83014-0008-01",
"ProductNDC": "83014-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Female Balance",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Caulophyllum Thalictrines, Cimicifuga Racemosa, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Rubus Idaeus, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Hepar Sulphuris Calcareum, Progesterone, Oxytocin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20240523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM SULFIDE; PROGESTERONE; OXYTOCIN",
"StrengthNumber": "2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 12; 30; 34",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Oxytocic [EPC], Oxytocin [CS], Plant Proteins [CS], Progesterone [CS], Progesterone [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240523",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides female hormonogenic balance support. †. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "0005-0100-02",
"PackageDescription": "1 SYRINGE in 1 CARTON (0005-0100-02) / .5 mL in 1 SYRINGE (0005-0100-01) ",
"NDC11Code": "00005-0100-02",
"ProductNDC": "0005-0100",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Trumenba",
"NonProprietaryName": "Meningococcal Group B Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20141105",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125549",
"LabelerName": "Wyeth Pharmaceutical Division of Wyeth Holdings LLC",
"SubstanceName": "NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN; NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN",
"StrengthNumber": "60; 60",
"StrengthUnit": "ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141105",
"SamplePackage": "N",
"IndicationAndUsage": "Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.",
"Description": "Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, one from fHbp subfamily A and one from subfamily B (A05 and B01, respectively).1 The proteins are individually produced in E. coli. Production strains are grown in defined fermentation growth media to a specific density. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added to the drug substances and is present in the final drug product. Each 0.5 mL dose contains 60 micrograms of each fHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al3+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0."
},
{
"NDCCode": "0005-0100-05",
"PackageDescription": "5 SYRINGE in 1 CARTON (0005-0100-05) / .5 mL in 1 SYRINGE (0005-0100-01) ",
"NDC11Code": "00005-0100-05",
"ProductNDC": "0005-0100",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Trumenba",
"NonProprietaryName": "Meningococcal Group B Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20141105",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125549",
"LabelerName": "Wyeth Pharmaceutical Division of Wyeth Holdings LLC",
"SubstanceName": "NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN; NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN",
"StrengthNumber": "60; 60",
"StrengthUnit": "ug/.5mL; ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141105",
"SamplePackage": "N",
"IndicationAndUsage": "Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.",
"Description": "Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, one from fHbp subfamily A and one from subfamily B (A05 and B01, respectively).1 The proteins are individually produced in E. coli. Production strains are grown in defined fermentation growth media to a specific density. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added to the drug substances and is present in the final drug product. Each 0.5 mL dose contains 60 micrograms of each fHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al3+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0."
},
{
"NDCCode": "0005-0100-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (0005-0100-10) / .5 mL in 1 SYRINGE (0005-0100-01) ",
"NDC11Code": "00005-0100-10",
"ProductNDC": "0005-0100",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Trumenba",
"NonProprietaryName": "Meningococcal Group B Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20141105",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125549",
"LabelerName": "Wyeth Pharmaceutical Division of Wyeth Holdings LLC",
"SubstanceName": "NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN; NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN",
"StrengthNumber": "60; 60",
"StrengthUnit": "ug/.5mL; ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141105",
"SamplePackage": "N",
"IndicationAndUsage": "Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.",
"Description": "Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, one from fHbp subfamily A and one from subfamily B (A05 and B01, respectively).1 The proteins are individually produced in E. coli. Production strains are grown in defined fermentation growth media to a specific density. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added to the drug substances and is present in the final drug product. Each 0.5 mL dose contains 60 micrograms of each fHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al3+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0."
},
{
"NDCCode": "0008-0100-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0100-01",
"ProductNDC": "0008-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Besponsa",
"NonProprietaryName": "Inotuzumab Ozogamicin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170818",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761040",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "INOTUZUMAB OZOGAMICIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170818",
"SamplePackage": "N",
"IndicationAndUsage": "BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.",
"Description": "Inotuzumab ozogamicin is a CD22-directed antibody and cytotoxic-drug conjugate (ADC) consisting of 3 components: 1) the recombinant humanized immunoglobulin class G subtype 4 (IgG4) kappa antibody inotuzumab, specific for human CD22, 2) N-acetyl-gamma-calicheamicin that causes double-stranded DNA breaks, and 3) an acid-cleavable linker composed of the condensation product of 4-(4'-acetylphenoxy)-butanoic acid (AcBut) and 3-methyl-3-mercaptobutane hydrazide (known as dimethylhydrazide) that covalently attaches N-acetyl-gamma-calicheamicin to inotuzumab. Inotuzumab ozogamicin has an approximate molecular weight of 160 kDa. The average number of calicheamicin derivative molecules conjugated to each inotuzumab molecule is approximately 6 with a distribution from 2–8. Inotuzumab ozogamicin is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the semisynthetic calicheamicin derivative is produced by microbial fermentation followed by synthetic modification. BESPONSA (inotuzumab ozogamicin) for injection is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous administration. Each single-dose vial delivers 0.9 mg inotuzumab ozogamicin. Inactive ingredients are polysorbate 80 (0.36 mg), sodium chloride (2.16 mg), sucrose (180 mg), and tromethamine (8.64 mg). After reconstitution with 4 mL of Sterile Water for Injection, USP, the final concentration is 0.25 mg/mL of inotuzumab ozogamicin with a deliverable volume of 3.6 mL (0.9 mg) and a pH of approximately 8.0."
},
{
"NDCCode": "0031-0100-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (0031-0100-04) / 118 mL in 1 BOTTLE",
"NDC11Code": "00031-0100-04",
"ProductNDC": "0031-0100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "650; 20; 400",
"StrengthUnit": "mg/20mL; mg/20mL; mg/20mL",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240215",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms occurring with a cold or flu: cough due to minor throat and bronchial irritationminor aches and painssore throatheadache, 2 temporarily reduces fever, 3 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive."
},
{
"NDCCode": "0031-0100-08",
"PackageDescription": "1 BOTTLE in 1 CARTON (0031-0100-08) / 237 mL in 1 BOTTLE",
"NDC11Code": "00031-0100-08",
"ProductNDC": "0031-0100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "650; 20; 400",
"StrengthUnit": "mg/20mL; mg/20mL; mg/20mL",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240215",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms occurring with a cold or flu: cough due to minor throat and bronchial irritationminor aches and painssore throatheadache, 2 temporarily reduces fever, 3 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive."
},
{
"NDCCode": "0053-0100-10",
"PackageDescription": "1 KIT in 1 CARTON (0053-0100-10) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) ",
"NDC11Code": "00053-0100-10",
"ProductNDC": "0053-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hemgenix",
"NonProprietaryName": "Etranacogene Dezaparvovec",
"DosageFormName": "KIT",
"StartMarketingDate": "20221122",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125772",
"LabelerName": "CSL Behring",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221122",
"SamplePackage": "N",
"IndicationAndUsage": "HEMGENIX is indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: 1 Currently use Factor IX prophylaxis therapy, or, 2 Have current or historical life-threatening hemorrhage, or, 3 Have repeated, serious spontaneous bleeding episodes.",
"Description": "HEMGENIX (etranacogene dezaparvovec-drlb) is an adeno-associated viral vector-based gene therapy for intravenous infusion after dilution. HEMGENIX is a non-replicating recombinant AAV5 containing a codon-optimized DNA sequence of the gain-of-function Padua variant of human Factor IX (variant R338L), under control of a liver-specific promotor 1 (LP1). HEMGENIX has a nominal concentration of 1 × 1013 gc/mL. Each vial contains an extractable volume of no less than 10 mL of HEMGENIX and the following excipients: sucrose (50 mg/mL), polysorbate-20 (0.22 mg/mL), potassium chloride (0.2 mg/mL), potassium phosphate (0.2 mg/mL), sodium chloride (8 mg/mL), and sodium phosphate (1.2 mg/mL). HEMGENIX is sterile, clear and colorless suspension, and contains no preservative. After dilution, HEMGENIX should be clear and colorless suspension."
},
{
"NDCCode": "0054-0100-22",
"PackageDescription": "90 TABLET in 1 BOTTLE (0054-0100-22) ",
"NDC11Code": "00054-0100-22",
"ProductNDC": "0054-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070709",
"EndMarketingDate": "20200820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077262",
"LabelerName": "West-Ward Pharmaceuticals Corp.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070709",
"EndMarketingDatePackage": "20200820",
"SamplePackage": "N"
},
{
"NDCCode": "0054-0100-31",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0054-0100-31) ",
"NDC11Code": "00054-0100-31",
"ProductNDC": "0054-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070709",
"EndMarketingDate": "20200820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077262",
"LabelerName": "West-Ward Pharmaceuticals Corp.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150527",
"EndMarketingDatePackage": "20200820",
"SamplePackage": "N"
},
{
"NDCCode": "0067-0100-06",
"PackageDescription": "6 PACKET in 1 CARTON (0067-0100-06) / 1 POWDER, FOR SOLUTION in 1 PACKET",
"NDC11Code": "00067-0100-06",
"ProductNDC": "0067-0100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Theraflu Severe Cold Relief Daytime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20231201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "500; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231201",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold: ominor aches and painsominor sore throat painoheadacheocough due to minor throat and bronchial irritation. temporarily reduces fever."
},
{
"NDCCode": "0067-0100-99",
"PackageDescription": "1000 PACKET in 1 CONTAINER (0067-0100-99) / 1 POWDER, FOR SOLUTION in 1 PACKET",
"NDC11Code": "00067-0100-99",
"ProductNDC": "0067-0100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Theraflu Severe Cold Relief Daytime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20231201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "500; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
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</NDC>
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</NDC>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Carolinas Weight Loss Institute</LabelerName>
<SubstanceName>FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM SULFIDE; PROGESTERONE; OXYTOCIN</SubstanceName>
<StrengthNumber>2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 12; 30; 34</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Oxytocic [EPC], Oxytocin [CS], Plant Proteins [CS], Progesterone [CS], Progesterone [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides female hormonogenic balance support. †. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0005-0100-02</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0005-0100-02) / .5 mL in 1 SYRINGE (0005-0100-01) </PackageDescription>
<NDC11Code>00005-0100-02</NDC11Code>
<ProductNDC>0005-0100</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Trumenba</ProprietaryName>
<NonProprietaryName>Meningococcal Group B Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20141105</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125549</ApplicationNumber>
<LabelerName>Wyeth Pharmaceutical Division of Wyeth Holdings LLC</LabelerName>
<SubstanceName>NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN; NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN</SubstanceName>
<StrengthNumber>60; 60</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.</IndicationAndUsage>
<Description>Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, one from fHbp subfamily A and one from subfamily B (A05 and B01, respectively).1 The proteins are individually produced in E. coli. Production strains are grown in defined fermentation growth media to a specific density. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added to the drug substances and is present in the final drug product. Each 0.5 mL dose contains 60 micrograms of each fHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al3+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0005-0100-05</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (0005-0100-05) / .5 mL in 1 SYRINGE (0005-0100-01) </PackageDescription>
<NDC11Code>00005-0100-05</NDC11Code>
<ProductNDC>0005-0100</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Trumenba</ProprietaryName>
<NonProprietaryName>Meningococcal Group B Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20141105</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125549</ApplicationNumber>
<LabelerName>Wyeth Pharmaceutical Division of Wyeth Holdings LLC</LabelerName>
<SubstanceName>NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN; NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN</SubstanceName>
<StrengthNumber>60; 60</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.</IndicationAndUsage>
<Description>Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, one from fHbp subfamily A and one from subfamily B (A05 and B01, respectively).1 The proteins are individually produced in E. coli. Production strains are grown in defined fermentation growth media to a specific density. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added to the drug substances and is present in the final drug product. Each 0.5 mL dose contains 60 micrograms of each fHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al3+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0005-0100-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (0005-0100-10) / .5 mL in 1 SYRINGE (0005-0100-01) </PackageDescription>
<NDC11Code>00005-0100-10</NDC11Code>
<ProductNDC>0005-0100</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Trumenba</ProprietaryName>
<NonProprietaryName>Meningococcal Group B Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20141105</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125549</ApplicationNumber>
<LabelerName>Wyeth Pharmaceutical Division of Wyeth Holdings LLC</LabelerName>
<SubstanceName>NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN; NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN</SubstanceName>
<StrengthNumber>60; 60</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.</IndicationAndUsage>
<Description>Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, one from fHbp subfamily A and one from subfamily B (A05 and B01, respectively).1 The proteins are individually produced in E. coli. Production strains are grown in defined fermentation growth media to a specific density. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added to the drug substances and is present in the final drug product. Each 0.5 mL dose contains 60 micrograms of each fHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al3+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0008-0100-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0100-01</NDC11Code>
<ProductNDC>0008-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Besponsa</ProprietaryName>
<NonProprietaryName>Inotuzumab Ozogamicin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170818</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761040</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>INOTUZUMAB OZOGAMICIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.</IndicationAndUsage>
<Description>Inotuzumab ozogamicin is a CD22-directed antibody and cytotoxic-drug conjugate (ADC) consisting of 3 components: 1) the recombinant humanized immunoglobulin class G subtype 4 (IgG4) kappa antibody inotuzumab, specific for human CD22, 2) N-acetyl-gamma-calicheamicin that causes double-stranded DNA breaks, and 3) an acid-cleavable linker composed of the condensation product of 4-(4'-acetylphenoxy)-butanoic acid (AcBut) and 3-methyl-3-mercaptobutane hydrazide (known as dimethylhydrazide) that covalently attaches N-acetyl-gamma-calicheamicin to inotuzumab. Inotuzumab ozogamicin has an approximate molecular weight of 160 kDa. The average number of calicheamicin derivative molecules conjugated to each inotuzumab molecule is approximately 6 with a distribution from 2–8. Inotuzumab ozogamicin is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the semisynthetic calicheamicin derivative is produced by microbial fermentation followed by synthetic modification. BESPONSA (inotuzumab ozogamicin) for injection is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous administration. Each single-dose vial delivers 0.9 mg inotuzumab ozogamicin. Inactive ingredients are polysorbate 80 (0.36 mg), sodium chloride (2.16 mg), sucrose (180 mg), and tromethamine (8.64 mg). After reconstitution with 4 mL of Sterile Water for Injection, USP, the final concentration is 0.25 mg/mL of inotuzumab ozogamicin with a deliverable volume of 3.6 mL (0.9 mg) and a pH of approximately 8.0.</Description>
</NDC>
<NDC>
<NDCCode>0031-0100-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0031-0100-04) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00031-0100-04</NDC11Code>
<ProductNDC>0031-0100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>650; 20; 400</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves these symptoms occurring with a cold or flu: cough due to minor throat and bronchial irritationminor aches and painssore throatheadache, 2 temporarily reduces fever, 3 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0031-0100-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0031-0100-08) / 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00031-0100-08</NDC11Code>
<ProductNDC>0031-0100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>650; 20; 400</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves these symptoms occurring with a cold or flu: cough due to minor throat and bronchial irritationminor aches and painssore throatheadache, 2 temporarily reduces fever, 3 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0053-0100-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0053-0100-10) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) </PackageDescription>
<NDC11Code>00053-0100-10</NDC11Code>
<ProductNDC>0053-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hemgenix</ProprietaryName>
<NonProprietaryName>Etranacogene Dezaparvovec</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20221122</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125772</ApplicationNumber>
<LabelerName>CSL Behring</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HEMGENIX is indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: 1 Currently use Factor IX prophylaxis therapy, or, 2 Have current or historical life-threatening hemorrhage, or, 3 Have repeated, serious spontaneous bleeding episodes.</IndicationAndUsage>
<Description>HEMGENIX (etranacogene dezaparvovec-drlb) is an adeno-associated viral vector-based gene therapy for intravenous infusion after dilution. HEMGENIX is a non-replicating recombinant AAV5 containing a codon-optimized DNA sequence of the gain-of-function Padua variant of human Factor IX (variant R338L), under control of a liver-specific promotor 1 (LP1). HEMGENIX has a nominal concentration of 1 × 1013 gc/mL. Each vial contains an extractable volume of no less than 10 mL of HEMGENIX and the following excipients: sucrose (50 mg/mL), polysorbate-20 (0.22 mg/mL), potassium chloride (0.2 mg/mL), potassium phosphate (0.2 mg/mL), sodium chloride (8 mg/mL), and sodium phosphate (1.2 mg/mL). HEMGENIX is sterile, clear and colorless suspension, and contains no preservative. After dilution, HEMGENIX should be clear and colorless suspension.</Description>
</NDC>
<NDC>
<NDCCode>0054-0100-22</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (0054-0100-22) </PackageDescription>
<NDC11Code>00054-0100-22</NDC11Code>
<ProductNDC>0054-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070709</StartMarketingDate>
<EndMarketingDate>20200820</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077262</ApplicationNumber>
<LabelerName>West-Ward Pharmaceuticals Corp.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070709</StartMarketingDatePackage>
<EndMarketingDatePackage>20200820</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0054-0100-31</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (0054-0100-31) </PackageDescription>
<NDC11Code>00054-0100-31</NDC11Code>
<ProductNDC>0054-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070709</StartMarketingDate>
<EndMarketingDate>20200820</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077262</ApplicationNumber>
<LabelerName>West-Ward Pharmaceuticals Corp.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150527</StartMarketingDatePackage>
<EndMarketingDatePackage>20200820</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0067-0100-06</NDCCode>
<PackageDescription>6 PACKET in 1 CARTON (0067-0100-06) / 1 POWDER, FOR SOLUTION in 1 PACKET</PackageDescription>
<NDC11Code>00067-0100-06</NDC11Code>
<ProductNDC>0067-0100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Theraflu Severe Cold Relief Daytime</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>500; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold: ominor aches and painsominor sore throat painoheadacheocough due to minor throat and bronchial irritation. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-0100-99</NDCCode>
<PackageDescription>1000 PACKET in 1 CONTAINER (0067-0100-99) / 1 POWDER, FOR SOLUTION in 1 PACKET</PackageDescription>
<NDC11Code>00067-0100-99</NDC11Code>
<ProductNDC>0067-0100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Theraflu Severe Cold Relief Daytime</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>500; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold: ominor aches and painsominor sore throat painoheadacheocough due to minor throat and bronchial irritation. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-0122-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (0067-0122-01) * 6 PACKET in 1 CARTON (0067-0100-06) / 1 POWDER, FOR SOLUTION in 1 PACKET * 6 PACKET in 1 CARTON (0067-0101-06) / 1 POWDER, FOR SOLUTION in 1 PACKET</PackageDescription>
<NDC11Code>00067-0122-01</NDC11Code>
<ProductNDC>0067-0122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Theraflu</ProprietaryName>
<ProprietaryNameSuffix>Severe Cold Relief Combo Pack</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0067-0123-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (0067-0123-01) * 6 PACKET in 1 CARTON (0067-0100-06) / 1 POWDER, FOR SOLUTION in 1 PACKET * 6 PACKET in 1 CARTON (0067-0101-06) / 1 POWDER, FOR SOLUTION in 1 PACKET</PackageDescription>
<NDC11Code>00067-0123-01</NDC11Code>
<ProductNDC>0067-0123</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Theraflu</ProprietaryName>
<ProprietaryNameSuffix>Severe Cold Relief Combo Pack</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0116-0100-05</NDCCode>
<PackageDescription>20000 g in 1 JUG (0116-0100-05)</PackageDescription>
<NDC11Code>00116-0100-05</NDC11Code>
<ProductNDC>0116-0100</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Chlorhexidine Gluconate 20% Solution</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>19850101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/20g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0116-0100-55</NDCCode>
<PackageDescription>213000 g in 1 DRUM (0116-0100-55) </PackageDescription>
<NDC11Code>00116-0100-55</NDC11Code>
<ProductNDC>0116-0100</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Chlorhexidine Gluconate 20% Solution</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>19850101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/20g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-29</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-85</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0116-0100-75</NDCCode>
<PackageDescription>1040000 g in 1 DRUM (0116-0100-75) </PackageDescription>
<NDC11Code>00116-0100-75</NDC11Code>
<ProductNDC>0116-0100</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Chlorhexidine Gluconate 20% Solution</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>19850101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/20g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-29</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-85</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0179-0100-44</NDCCode>
<PackageDescription>1440 TABLET, FILM COATED in 1 BOTTLE (0179-0100-44) </PackageDescription>
<NDC11Code>00179-0100-44</NDC11Code>
<ProductNDC>0179-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110912</StartMarketingDate>
<EndMarketingDate>20200131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077851</ApplicationNumber>
<LabelerName>KAISER FOUNDATION HOSPITALS</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110912</StartMarketingDatePackage>
<EndMarketingDatePackage>20200131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-0100-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-0100-10) </PackageDescription>
<NDC11Code>00268-0100-10</NDC11Code>
<ProductNDC>0268-0100</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Center-al - Acer Saccharum Pollen</ProprietaryName>
<NonProprietaryName>Acer Saccharum Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-0100-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (0268-0100-30) </PackageDescription>
<NDC11Code>00268-0100-30</NDC11Code>
<ProductNDC>0268-0100</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Center-al - Acer Saccharum Pollen</ProprietaryName>
<NonProprietaryName>Acer Saccharum Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.</IndicationAndUsage>
<Description>Center-Al® (Allergenic extracts, Alum Precipitated) is prepared from aqueous allergenic extracts by the formation of an aluminum hydroxide precipitated complex. It is supplied as a sterile suspension in multiple dose vials for subcutaneous injection. 0.4% Phenol is added as a preservative. This product is compounded and diluted on a PNU basis. Extracts containing Short Ragweed Pollen also bear a labeled potency declaration in terms of Antigen E content.</Description>
</NDC>
<NDC>
<NDCCode>0295-0100-52</NDCCode>
<PackageDescription>1 INHALANT in 1 INHALER (0295-0100-52) </PackageDescription>
<NDC11Code>00295-0100-52</NDC11Code>
<ProductNDC>0295-0100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benzedrex Nasal Decongestant</ProprietaryName>
<NonProprietaryName>Propylhexedrine</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20190121</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Denison Pharmaceuticals LLC</LabelerName>
<SubstanceName>PROPYLHEXEDRINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0316-0100-06</NDCCode>
<PackageDescription>178 mL in 1 BOTTLE (0316-0100-06) </PackageDescription>
<NDC11Code>00316-0100-06</NDC11Code>
<ProductNDC>0316-0100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ulcerease</ProprietaryName>
<NonProprietaryName>Phenol 0.6% Anesthetic Oral Rinse</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19770328</StartMarketingDate>
<EndMarketingDate>20250829</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>PHENOL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19770328</StartMarketingDatePackage>
<EndMarketingDatePackage>20250829</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief of occasional minor irritation, pain, sore mouth, sore throat, canker sores and teething.</IndicationAndUsage>
</NDC>
</NDCList>