{
"NDC": [
{
"NDCCode": "70163-0024-2",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (70163-0024-2) / 120 mL in 1 BOTTLE, GLASS (70163-0024-1) ",
"NDC11Code": "70163-0024-02",
"ProductNDC": "70163-0024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough And Mucus Night",
"NonProprietaryName": "Antimonium Tartaricum, Avena Sativa, Bryonia (alba), Chamomilla, Drosera (rotundifolia), Hepar Sulphuris Calcareum, Hydrastis Canadensis, Kali Bichromicum, Passiflora Incarnata, Pulsatilla (pratensis), Sambucus Nigra, Stannum Metallicum, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260202",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; AVENA SATIVA FLOWERING TOP; BRYONIA ALBA ROOT; MATRICARIA CHAMOMILLA WHOLE; DROSERA ROTUNDIFOLIA WHOLE; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA PRATENSIS WHOLE; SAMBUCUS NIGRA FLOWERING TOP; TIN; SULFUR",
"StrengthNumber": "6; 8; 6; 8; 6; 12; 5; 12; 6; 6; 3; 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",
"Status": "Active",
"LastUpdate": "2026-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260202",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve ■ chest congestion ■ hacking cough ■ thick mucus in chest, throat and nose*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0010-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (70163-0010-2) / 125 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (70163-0010-1) ",
"NDC11Code": "70163-0010-02",
"ProductNDC": "70163-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No More Monsters",
"NonProprietaryName": "Calcarea Carbonica, Kali Phosphoricum, Lycopodium Clavatum, Passiflora Incarnata, Gallicum Acidum",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20260310",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; DIBASIC POTASSIUM PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; PASSIFLORA INCARNATA FLOWERING TOP; GALLIC ACID MONOHYDRATE",
"StrengthNumber": "6; 6; 6; 4; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260310",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve ■ frightful dreams ■ sleeplessness ■ frequent waking*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0012-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70163-0012-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0012-1) ",
"NDC11Code": "70163-0012-02",
"ProductNDC": "70163-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nervefix Sciatica",
"NonProprietaryName": "Belladonna, Cimicifuga Racemosa, Gelsemium Sempervirens, Spigelia Anthelmia, Gnaphalium Polycephalum, Magnesia Phosphorica",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "ATROPA BELLADONNA; BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; SPIGELIA ANTHELMIA WHOLE; PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
"StrengthNumber": "6; 6; 6; 6; 6; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260203",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve. ■ sciatica pain ■ pain extending into legs ■ neuralgia ■ back pain. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone."
},
{
"NDCCode": "70163-0013-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70163-0013-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0013-1) ",
"NDC11Code": "70163-0013-02",
"ProductNDC": "70163-0013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Animal Hair And Dander",
"NonProprietaryName": "Adrenalinum, Allium Cepa, Arsenicum Iodatum, Cat (dander), Dog (dander), Euphrasia Officinalis, Histaminum Hydrochloricum, Sabadilla, Sheep Wool, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260410",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "EPINEPHRINE; ONION; ARSENIC TRIIODIDE; FELIS CATUS DANDER; CANIS LUPUS FAMILIARIS DANDER; EUPHRASIA STRICTA; HISTAMINE DIHYDROCHLORIDE; SCHOENOCAULON OFFICINALE SEED; SHEEP WOOL; SILICON DIOXIDE",
"StrengthNumber": "6; 6; 6; 12; 12; 6; 12; 6; 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",
"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], Cells, Epidermal [EXT], Dander [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Dander Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260410",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve allergy symptoms. ■ congestion ■itchy, watery eyes ■ sneezing ■ rashes*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0017-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (70163-0017-2) / 125 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (70163-0017-1) ",
"NDC11Code": "70163-0017-02",
"ProductNDC": "70163-0017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Peace And Quiet",
"NonProprietaryName": "Chamomilla, Ignatia Amara, Lycopodium Clavatum, Magnesium Muriatica, Passiflora Incarnata",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20260302",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "MATRICARIA CHAMOMILLA WHOLE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP",
"StrengthNumber": "4; 6; 6; 6; 4",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260302",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve ■ fussiness ■ oversensitivity ■ sleeplessness*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0018-2",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (70163-0018-2) / 30 mL in 1 BOTTLE, SPRAY (70163-0018-1) ",
"NDC11Code": "70163-0018-02",
"ProductNDC": "70163-0018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thyroid Support",
"NonProprietaryName": "Calcarea Carbonica, Calcarea Iodata, Causticum, Ferrum Iodatum, Fucus Vesiculosus, Kali Iodatum, Natrum Muriaticum, Thyroidinum (bovine)",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20260304",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM IODIDE; CAUSTICUM; FERROUS IODIDE; FUCUS VESICULOSUS; POTASSIUM IODIDE; SODIUM CHLORIDE; THYROID, BOVINE",
"StrengthNumber": "10; 6; 10; 10; 6; 6; 10; 6",
"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",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260304",
"SamplePackage": "N",
"IndicationAndUsage": "May help to provide temporary glandular support for symptoms of. ■ low energy ■ low metabolism ■ cold hands & feet ■ melancholy*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone."
},
{
"NDCCode": "70163-0019-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70163-0019-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0019-1) ",
"NDC11Code": "70163-0019-02",
"ProductNDC": "70163-0019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mold, Yeast And Dust",
"NonProprietaryName": "Adrenalinum, Arsenicum Iodatum, Aspergillus Flavus, Aspergillus Fumigatus, Aspergillus Glaucus, Aspergillus Nidulans, Aspergillus Niger, Candida Albicans, Dermatophagoides Farinae, Histaminum Hydrochloricum, Lycopodium Clavatum, Mucor Plumbeus, Natrum Sulphuricum, Penicillium Digitatum, Penicillium Roquefortii, Saccharomyces Cerevisiae, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260202",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "EPINEPHRINE; ARSENIC TRIIODIDE; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; EUROTIUM HERBARIORUM; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; DERMATOPHAGOIDES FARINAE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; MUCOR PLUMBEUS; SODIUM SULFATE; PENICILLIUM DIGITATUM; PENICILLIUM ROQUEFORTI; SACCHAROMYCES CEREVISIAE; SILICON DIOXIDE",
"StrengthNumber": "6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 6; 12; 6; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/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], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Antigens, Dermatophagoides [CS], Catecholamine [EPC], Catecholamines [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], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal 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 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], Insect Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260202",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve allergy symptoms. ■ congestion ■ headache ■ itchy, watery eyes ■ sneezing. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0020-2",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (70163-0020-2) / 24 mL in 1 BOTTLE, SPRAY (70163-0020-1) ",
"NDC11Code": "70163-0020-02",
"ProductNDC": "70163-0020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Nasal",
"NonProprietaryName": "Adrenalinum, Allium Cepa, Ambrosia Artemisiaefolia, Echinacea (angustifolia), Gelsemium Sempervirens, Kali Iodatum, Sanguinaria Canadensis, Sticta Pulmonaria",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20260514",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "EPINEPHRINE; ONION; AMBROSIA ARTEMISIIFOLIA WHOLE; ECHINACEA ANGUSTIFOLIA WHOLE; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE; SANGUINARIA CANADENSIS ROOT; LOBARIA PULMONARIA",
"StrengthNumber": "6; 6; 12; 6; 6; 9; 6; 6",
"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",
"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], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260514",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve allergy symptoms. ■ sinus pressure ■ sinus headache ■ congestion ■ runny nose ■ dry nasal passages ■ sneezing *. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0023-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70163-0023-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0023-1) ",
"NDC11Code": "70163-0023-02",
"ProductNDC": "70163-0023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Grass Pollen",
"NonProprietaryName": "Adrenalinum, Allium Cepa, Arsenicum Iodatum, Oats (avena Sativa), Brome Grass (bromus Inermis), Bermuda Grass (cynodon Dactylon), Orchard Grass (dactylis Glomerata), Euphrasia Officinalis, Meadow Grass (festuca Elatior Pratensis), Histaminum Hydrochloricum, Perennial Rye Grass (lolium Perenne), Timothy Grass (phleum Pratense), Sabadilla, Sanguinaria Canadensis, Rye Grass (secale Cereale), Johnson Grass (sorghum Halepense), Wheat Grass (triticum Aestivum), Corn (zea Mays)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260310",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "EPINEPHRINE; ONION; ARSENIC TRIIODIDE; AVENA SATIVA POLLEN; BROMUS INERMIS POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; EUPHRASIA STRICTA; LOLIUM PRATENSE POLLEN; HISTAMINE DIHYDROCHLORIDE; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; SCHOENOCAULON OFFICINALE SEED; SANGUINARIA CANADENSIS ROOT; SECALE CEREALE POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; ZEA MAYS POLLEN",
"StrengthNumber": "6; 6; 6; 12; 12; 12; 12; 6; 12; 12; 12; 12; 6; 6; 12; 12; 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",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [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], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased 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], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260310",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve allergy symptoms. ■ runny nose ■ congestion ■ headache ■ itchy, watery eyes ■ sneezing*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0025-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70163-0025-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0025-1) ",
"NDC11Code": "70163-0025-02",
"ProductNDC": "70163-0025",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida Yeast Care",
"NonProprietaryName": "Baptisia Tinctoria, Bryonia (alba), Candida Albicans, Candida Parapsilosis, Echinacea (angustifolia), Eupatorium Perfoliatum, Thuja Occidentalis, Viscum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "BAPTISIA TINCTORIA WHOLE; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "3; 3; 12; 12; 3; 6; 3; 3",
"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",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve. ■ symptoms of yeast infection ■ itching ■ burning ■ discharge ■ odor*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0029-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70163-0029-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0029-1) ",
"NDC11Code": "70163-0029-02",
"ProductNDC": "70163-0029",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tree Pollen",
"NonProprietaryName": "Acer Negundo, Acer Rubrum, Adrenalinum, Allium Cepa, Arsenicum Iodatum, Betula Nigra, Euphrasia Officinalis, Fraxinus Americana, Histaminum Hydrochloricum, Ligustrum Vulgare, Liquidambar Styraciflua, Morus Alba, Pinus Strobus, Populus Deltoides, Quercus Rubra, Sabadilla, Salix Nigra, Sanguinaria Canadensis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260304",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; EPINEPHRINE; ONION; ARSENIC TRIIODIDE; BETULA NIGRA POLLEN; EUPHRASIA STRICTA; FRAXINUS AMERICANA POLLEN; HISTAMINE DIHYDROCHLORIDE; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MORUS ALBA POLLEN; PINUS STROBUS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; SCHOENOCAULON OFFICINALE SEED; SALIX NIGRA POLLEN; SANGUINARIA CANADENSIS ROOT",
"StrengthNumber": "12; 12; 6; 6; 6; 12; 6; 12; 12; 12; 12; 12; 12; 12; 12; 6; 12; 6",
"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",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [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], 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], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260304",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve allergy symptoms. ■ congestion ■ headache ■ itchy, watery eyes ■ sneezing*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone."
},
{
"NDCCode": "70163-0030-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70163-0030-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0030-1) ",
"NDC11Code": "70163-0030-02",
"ProductNDC": "70163-0030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinufix",
"NonProprietaryName": "Thuja Occidentalis, Antimonium Tartaricum, Kali Bichromicum, Mercurius Iodatus Ruber, Spongia Tosta, Hepar Sulphuris Calcareum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260422",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG; ANTIMONY POTASSIUM TARTRATE; POTASSIUM DICHROMATE; MERCURIC IODIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; CALCIUM SULFIDE",
"StrengthNumber": "6; 6; 6; 12; 10; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260422",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve. ■ sinus symptoms ■ sinus headache ■ nasal congestion ■ sinus pressure ■ sneezing*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0031-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70163-0031-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0031-1) ",
"NDC11Code": "70163-0031-02",
"ProductNDC": "70163-0031",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pollen Hayfever",
"NonProprietaryName": "Adrenalinum, Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Iodatum, Mugwort Pollen (artemisia Vulgaris), Bellis Perennis, Brassica Spp, Chenopodium Album, Euphrasia Officinalis, Histaminum Hydrochloricum, Alfalfa Pollen (medicago Sativa), Phleum Pratense, Yellow Dock Pollen (rumex Crispus), Sabadilla, Silicea, Goldenrod Pollen (solidago Canadensis), Dandelion Pollen (taraxacum Officinale), Red Clover Pollen (trifolium Pratense), Xanthium Strumarium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260505",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "EPINEPHRINE; ONION; AMBROSIA ARTEMISIIFOLIA WHOLE; ARSENIC TRIIODIDE; ARTEMISIA VULGARIS POLLEN; BELLIS PERENNIS WHOLE; BRASSICA RAPA SUBSP. OLEIFERA POLLEN; CHENOPODIUM ALBUM POLLEN; EUPHRASIA STRICTA; HISTAMINE DIHYDROCHLORIDE; MEDICAGO SATIVA POLLEN; PHLEUM PRATENSE POLLEN; RUMEX CRISPUS POLLEN; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SOLIDAGO CANADENSIS POLLEN; TARAXACUM OFFICINALE POLLEN; TRIFOLIUM PRATENSE POLLEN; XANTHIUM STRUMARIUM POLLEN",
"StrengthNumber": "6; 6; 12; 6; 12; 12; 12; 12; 6; 12; 12; 12; 12; 6; 12; 12; 12; 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",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [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], 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 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], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260505",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve allergy symptoms. ■ runny nose ■ congestion ■ headache ■ itchy, watery eyes, ■ sneezing*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0033-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (70163-0033-2) / 125 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (70163-0033-1) ",
"NDC11Code": "70163-0033-02",
"ProductNDC": "70163-0033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "A Plus Attention",
"NonProprietaryName": "Baryta Carbonica, Calcarea Phosphorica, Silicea, Gelsemium Sempervirens, Nux Vomica, Sinapis Nigra",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20260324",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; SILICON DIOXIDE; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; BLACK MUSTARD SEED",
"StrengthNumber": "10; 10; 10; 12; 12; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260324",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve ■ poor concentration ■ overactive mind ■ restlessness*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0034-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70163-0034-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0034-1) ",
"NDC11Code": "70163-0034-02",
"ProductNDC": "70163-0034",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Adrenal Support",
"NonProprietaryName": "Adrenalinum, Argentum Nitricum, Berberis Vulgaris, Natrum Muriaticum, Oleum Morrhuae, Petroleum, Vanadium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260324",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "EPINEPHRINE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; SODIUM CHLORIDE; COD LIVER OIL; KEROSENE; VANADIUM",
"StrengthNumber": "6; 10; 6; 10; 12; 12; 10",
"StrengthUnit": "[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], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260324",
"SamplePackage": "N",
"IndicationAndUsage": "May help to provide temporary glandular support for symptoms of. ■ low energy ■ low metabolism ■ inflammation ■ stress. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone."
},
{
"NDCCode": "70163-0035-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70163-0035-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0035-1) ",
"NDC11Code": "70163-0035-02",
"ProductNDC": "70163-0035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Care",
"NonProprietaryName": "Adrenalinum, Ragweed, Pollen (ambrosia Artemisiaefolia), Apis Mellifica, Echinacea (angustifolia), Histaminum Hydrochloricum, Ledum Palustre, Lycopodium Clavatum, Natrum Muriaticum, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260323",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "EPINEPHRINE; AMBROSIA ARTEMISIIFOLIA POLLEN; APIS MELLIFERA; ECHINACEA ANGUSTIFOLIA WHOLE; HISTAMINE DIHYDROCHLORIDE; RHODODENDRON TOMENTOSUM LEAFY TWIG; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SULFUR",
"StrengthNumber": "6; 6; 6; 4; 12; 8; 6; 8; 6",
"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",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [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], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260323",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve allergy symptoms of ■ nasal and sinus congestion ■ runny nose ■ skin irritations ■ sneezing ■ watery eyes*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone."
},
{
"NDCCode": "70163-0036-2",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (70163-0036-2) / 120 mL in 1 BOTTLE, GLASS (70163-0036-1) ",
"NDC11Code": "70163-0036-02",
"ProductNDC": "70163-0036",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough And Mucus",
"NonProprietaryName": "Antimonium Tartaricum, Euphrasia Officinalis, Hepar Sulphuris Calcareum, Hydrastis Canadensis, Kali Bichromicum, Pulsatilla (pratensis), Stannum Metallicum, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260323",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; EUPHRASIA STRICTA; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; TIN; SULFUR",
"StrengthNumber": "6; 6; 12; 5; 12; 6; 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",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260323",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve ■ chest congestion ■ hacking cough ■ thick mucus in chest, throat and nose*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0039-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70163-0039-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0039-1) ",
"NDC11Code": "70163-0039-02",
"ProductNDC": "70163-0039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uti Care",
"NonProprietaryName": "Barosma (betulina), Dulcamara, Equisetum Hyemale, Terebinthina, Sarsaparilla (smilax Regelii) Triticum Repens",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260320",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "AGATHOSMA BETULINA LEAF; SOLANUM DULCAMARA TOP; EQUISETUM HYEMALE WHOLE; TURPENTINE OIL; SMILAX ORNATA ROOT; ELYMUS REPENS ROOT",
"StrengthNumber": "5; 3; 6; 4; 4; 4",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260320",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve. ■ bladder symptoms ■ urge to urinate ■ frequent urination ■ painful urination. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "70163-0040-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70163-0040-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0040-1) ",
"NDC11Code": "70163-0040-02",
"ProductNDC": "70163-0040",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu Relief",
"NonProprietaryName": "Aconitum Napellus, Allium Cepa, Echinacea (angustifolia), Euphrasia Officinalis, Gelsemium Sempervirens, Sanguinaria Canadensis, Sticta Pulmonaria",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260323",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "ACONITUM NAPELLUS WHOLE; ONION; ECHINACEA ANGUSTIFOLIA WHOLE; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; SANGUINARIA CANADENSIS ROOT; LOBARIA PULMONARIA",
"StrengthNumber": "3; 6; 3; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260323",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve. ■ congestion ■ cough ■ nausea ■ sneezing ■ runny nose ■ headache ■ body ache*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone."
},
{
"NDCCode": "70163-0047-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (70163-0047-2) / 120 TABLET in 1 BOTTLE, PLASTIC (70163-0047-1) ",
"NDC11Code": "70163-0047-02",
"ProductNDC": "70163-0047",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anxiety Relief",
"NonProprietaryName": "Aconitum Napellus, Argentum Nitricum, Arsenicum Album, Aurum Metallicum, Gelsemium Sempervirens, Hyoscyamus Niger, Ignatia Amara, Kali Carbonicum, Moschus, Natrum Muriaticum, Piper Methysticum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260415",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NaturalCare",
"SubstanceName": "ACONITUM NAPELLUS WHOLE; SILVER NITRATE; ARSENIC TRIOXIDE; GOLD; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; SODIUM CHLORIDE; PIPER METHYSTICUM ROOT",
"StrengthNumber": "9; 8; 9; 8; 8; 6; 6; 12; 12; 6; 7",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260415",
"SamplePackage": "N",
"IndicationAndUsage": "May help temporarily relieve ■ occasional minor anxiety ■ fear ■ anguish ■ stress and worry of everyday life ■ nervousness*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "0024-5747-02",
"PackageDescription": "2 SYRINGE in 1 CARTON (0024-5747-02) / 3 mL in 1 SYRINGE",
"NDC11Code": "00024-5747-02",
"ProductNDC": "0024-5747",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adlyxin",
"NonProprietaryName": "Lixisenatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20160727",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208471",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "LIXISENATIDE",
"StrengthNumber": "100",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160727",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5831-02",
"PackageDescription": "2 INJECTION in 1 CARTON (0024-5831-02)",
"NDC11Code": "00024-5831-02",
"ProductNDC": "0024-5831",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvi-q",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20121115",
"EndMarketingDate": "20161231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201739",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "0024-5833-02",
"PackageDescription": "2 INJECTION in 1 CARTON (0024-5833-02)",
"NDC11Code": "00024-5833-02",
"ProductNDC": "0024-5833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvi-q",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20121115",
"EndMarketingDate": "20161231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201739",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "0024-5862-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0024-5862-01) / 1.2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00024-5862-01",
"ProductNDC": "0024-5862",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mozobil",
"NonProprietaryName": "Plerixafor",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20130901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022311",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "PLERIXAFOR",
"StrengthNumber": "24",
"StrengthUnit": "mg/1.2mL",
"Pharm_Classes": "Hematopoietic Stem Cell Mobilizer [EPC], Increased Hematopoietic Stem Cell Mobilization [PE]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130901",
"SamplePackage": "N",
"IndicationAndUsage": "Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).",
"Description": "Mozobil (plerixafor) injection is a sterile, preservative-free, clear, colorless to pale-yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor. Each single-dose vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required. Plerixafor is a hematopoietic stem cell mobilizer with a chemical name 1,4-Bis((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzene. It has the molecular formula C28H54N8. The molecular weight of plerixafor is 502.79 g/mol. The structural formula is provided in Figure 1. Figure 1: Structural Formula. Plerixafor is a white to off-white crystalline solid. It is hygroscopic. Plerixafor has a typical melting point of 131.5°C. The partition coefficient of plerixafor between 1-octanol and pH 7 aqueous buffer is <0.1."
},
{
"NDCCode": "0024-5871-02",
"PackageDescription": "2 SYRINGE in 1 CARTON (0024-5871-02) / 3 mL in 1 SYRINGE (0024-5871-00) ",
"NDC11Code": "00024-5871-02",
"ProductNDC": "0024-5871",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Toujeo Max",
"NonProprietaryName": "Insulin Glargine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA206538",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "300",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180326",
"SamplePackage": "N",
"IndicationAndUsage": "TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.",
"Description": "Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4."
},
{
"NDCCode": "0024-5901-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5901-02) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5901-02",
"ProductNDC": "0024-5901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Praluent",
"NonProprietaryName": "Alirocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125559",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ALIROCUMAB",
"StrengthNumber": "75",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N",
"IndicationAndUsage": "PRALUENT® is indicated: 1 To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease., 2 As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C., 3 As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C., 4 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.",
"Description": "Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0."
},
{
"NDCCode": "0024-5902-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (0024-5902-02) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5902-02",
"ProductNDC": "0024-5902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Praluent",
"NonProprietaryName": "Alirocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125559",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ALIROCUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N",
"IndicationAndUsage": "PRALUENT® is indicated: 1 To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease., 2 As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C., 3 As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C., 4 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.",
"Description": "Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0."
},
{
"NDCCode": "0024-5903-02",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0024-5903-02) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5903-02",
"ProductNDC": "0024-5903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Praluent",
"NonProprietaryName": "Alirocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125559",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ALIROCUMAB",
"StrengthNumber": "75",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5904-02",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0024-5904-02) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5904-02",
"ProductNDC": "0024-5904",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Praluent",
"NonProprietaryName": "Alirocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125559",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ALIROCUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5908-01",
"PackageDescription": "2 SYRINGE in 1 PACKAGE (0024-5908-01) / 1.14 mL in 1 SYRINGE (0024-5908-00) ",
"NDC11Code": "00024-5908-01",
"ProductNDC": "0024-5908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kevzara",
"NonProprietaryName": "Sarilumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20170522",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761037",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "SARILUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/1.14mL",
"Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170522",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).",
"Description": "Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70163-0024-2</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (70163-0024-2) / 120 mL in 1 BOTTLE, GLASS (70163-0024-1) </PackageDescription>
<NDC11Code>70163-0024-02</NDC11Code>
<ProductNDC>70163-0024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cough And Mucus Night</ProprietaryName>
<NonProprietaryName>Antimonium Tartaricum, Avena Sativa, Bryonia (alba), Chamomilla, Drosera (rotundifolia), Hepar Sulphuris Calcareum, Hydrastis Canadensis, Kali Bichromicum, Passiflora Incarnata, Pulsatilla (pratensis), Sambucus Nigra, Stannum Metallicum, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; AVENA SATIVA FLOWERING TOP; BRYONIA ALBA ROOT; MATRICARIA CHAMOMILLA WHOLE; DROSERA ROTUNDIFOLIA WHOLE; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA PRATENSIS WHOLE; SAMBUCUS NIGRA FLOWERING TOP; TIN; SULFUR</SubstanceName>
<StrengthNumber>6; 8; 6; 8; 6; 12; 5; 12; 6; 6; 3; 12; 12</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</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve ■ chest congestion ■ hacking cough ■ thick mucus in chest, throat and nose*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0010-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (70163-0010-2) / 125 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (70163-0010-1) </PackageDescription>
<NDC11Code>70163-0010-02</NDC11Code>
<ProductNDC>70163-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No More Monsters</ProprietaryName>
<NonProprietaryName>Calcarea Carbonica, Kali Phosphoricum, Lycopodium Clavatum, Passiflora Incarnata, Gallicum Acidum</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260310</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; DIBASIC POTASSIUM PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; PASSIFLORA INCARNATA FLOWERING TOP; GALLIC ACID MONOHYDRATE</SubstanceName>
<StrengthNumber>6; 6; 6; 4; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve ■ frightful dreams ■ sleeplessness ■ frequent waking*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0012-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70163-0012-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0012-1) </PackageDescription>
<NDC11Code>70163-0012-02</NDC11Code>
<ProductNDC>70163-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nervefix Sciatica</ProprietaryName>
<NonProprietaryName>Belladonna, Cimicifuga Racemosa, Gelsemium Sempervirens, Spigelia Anthelmia, Gnaphalium Polycephalum, Magnesia Phosphorica</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>ATROPA BELLADONNA; BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; SPIGELIA ANTHELMIA WHOLE; PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve. ■ sciatica pain ■ pain extending into legs ■ neuralgia ■ back pain. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0013-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70163-0013-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0013-1) </PackageDescription>
<NDC11Code>70163-0013-02</NDC11Code>
<ProductNDC>70163-0013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Animal Hair And Dander</ProprietaryName>
<NonProprietaryName>Adrenalinum, Allium Cepa, Arsenicum Iodatum, Cat (dander), Dog (dander), Euphrasia Officinalis, Histaminum Hydrochloricum, Sabadilla, Sheep Wool, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260410</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>EPINEPHRINE; ONION; ARSENIC TRIIODIDE; FELIS CATUS DANDER; CANIS LUPUS FAMILIARIS DANDER; EUPHRASIA STRICTA; HISTAMINE DIHYDROCHLORIDE; SCHOENOCAULON OFFICINALE SEED; SHEEP WOOL; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>6; 6; 6; 12; 12; 6; 12; 6; 12; 12</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</StrengthUnit>
<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], Cells, Epidermal [EXT], Dander [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Dander Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve allergy symptoms. ■ congestion ■itchy, watery eyes ■ sneezing ■ rashes*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0017-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (70163-0017-2) / 125 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (70163-0017-1) </PackageDescription>
<NDC11Code>70163-0017-02</NDC11Code>
<ProductNDC>70163-0017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Peace And Quiet</ProprietaryName>
<NonProprietaryName>Chamomilla, Ignatia Amara, Lycopodium Clavatum, Magnesium Muriatica, Passiflora Incarnata</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260302</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>MATRICARIA CHAMOMILLA WHOLE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP</SubstanceName>
<StrengthNumber>4; 6; 6; 6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve ■ fussiness ■ oversensitivity ■ sleeplessness*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0018-2</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (70163-0018-2) / 30 mL in 1 BOTTLE, SPRAY (70163-0018-1) </PackageDescription>
<NDC11Code>70163-0018-02</NDC11Code>
<ProductNDC>70163-0018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thyroid Support</ProprietaryName>
<NonProprietaryName>Calcarea Carbonica, Calcarea Iodata, Causticum, Ferrum Iodatum, Fucus Vesiculosus, Kali Iodatum, Natrum Muriaticum, Thyroidinum (bovine)</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260304</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM IODIDE; CAUSTICUM; FERROUS IODIDE; FUCUS VESICULOSUS; POTASSIUM IODIDE; SODIUM CHLORIDE; THYROID, BOVINE</SubstanceName>
<StrengthNumber>10; 6; 10; 10; 6; 6; 10; 6</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</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help to provide temporary glandular support for symptoms of. ■ low energy ■ low metabolism ■ cold hands & feet ■ melancholy*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0019-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70163-0019-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0019-1) </PackageDescription>
<NDC11Code>70163-0019-02</NDC11Code>
<ProductNDC>70163-0019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mold, Yeast And Dust</ProprietaryName>
<NonProprietaryName>Adrenalinum, Arsenicum Iodatum, Aspergillus Flavus, Aspergillus Fumigatus, Aspergillus Glaucus, Aspergillus Nidulans, Aspergillus Niger, Candida Albicans, Dermatophagoides Farinae, Histaminum Hydrochloricum, Lycopodium Clavatum, Mucor Plumbeus, Natrum Sulphuricum, Penicillium Digitatum, Penicillium Roquefortii, Saccharomyces Cerevisiae, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>EPINEPHRINE; ARSENIC TRIIODIDE; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; EUROTIUM HERBARIORUM; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; DERMATOPHAGOIDES FARINAE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; MUCOR PLUMBEUS; SODIUM SULFATE; PENICILLIUM DIGITATUM; PENICILLIUM ROQUEFORTI; SACCHAROMYCES CEREVISIAE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 6; 12; 6; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/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</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Antigens, Dermatophagoides [CS], Catecholamine [EPC], Catecholamines [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], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal 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 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], Insect Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve allergy symptoms. ■ congestion ■ headache ■ itchy, watery eyes ■ sneezing. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0020-2</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (70163-0020-2) / 24 mL in 1 BOTTLE, SPRAY (70163-0020-1) </PackageDescription>
<NDC11Code>70163-0020-02</NDC11Code>
<ProductNDC>70163-0020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Nasal</ProprietaryName>
<NonProprietaryName>Adrenalinum, Allium Cepa, Ambrosia Artemisiaefolia, Echinacea (angustifolia), Gelsemium Sempervirens, Kali Iodatum, Sanguinaria Canadensis, Sticta Pulmonaria</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260514</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>EPINEPHRINE; ONION; AMBROSIA ARTEMISIIFOLIA WHOLE; ECHINACEA ANGUSTIFOLIA WHOLE; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE; SANGUINARIA CANADENSIS ROOT; LOBARIA PULMONARIA</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 9; 6; 6</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</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], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve allergy symptoms. ■ sinus pressure ■ sinus headache ■ congestion ■ runny nose ■ dry nasal passages ■ sneezing *. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0023-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70163-0023-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0023-1) </PackageDescription>
<NDC11Code>70163-0023-02</NDC11Code>
<ProductNDC>70163-0023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Grass Pollen</ProprietaryName>
<NonProprietaryName>Adrenalinum, Allium Cepa, Arsenicum Iodatum, Oats (avena Sativa), Brome Grass (bromus Inermis), Bermuda Grass (cynodon Dactylon), Orchard Grass (dactylis Glomerata), Euphrasia Officinalis, Meadow Grass (festuca Elatior Pratensis), Histaminum Hydrochloricum, Perennial Rye Grass (lolium Perenne), Timothy Grass (phleum Pratense), Sabadilla, Sanguinaria Canadensis, Rye Grass (secale Cereale), Johnson Grass (sorghum Halepense), Wheat Grass (triticum Aestivum), Corn (zea Mays)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260310</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>EPINEPHRINE; ONION; ARSENIC TRIIODIDE; AVENA SATIVA POLLEN; BROMUS INERMIS POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; EUPHRASIA STRICTA; LOLIUM PRATENSE POLLEN; HISTAMINE DIHYDROCHLORIDE; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; SCHOENOCAULON OFFICINALE SEED; SANGUINARIA CANADENSIS ROOT; SECALE CEREALE POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; ZEA MAYS POLLEN</SubstanceName>
<StrengthNumber>6; 6; 6; 12; 12; 12; 12; 6; 12; 12; 12; 12; 6; 6; 12; 12; 12; 12</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</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [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], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased 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], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve allergy symptoms. ■ runny nose ■ congestion ■ headache ■ itchy, watery eyes ■ sneezing*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0025-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70163-0025-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0025-1) </PackageDescription>
<NDC11Code>70163-0025-02</NDC11Code>
<ProductNDC>70163-0025</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida Yeast Care</ProprietaryName>
<NonProprietaryName>Baptisia Tinctoria, Bryonia (alba), Candida Albicans, Candida Parapsilosis, Echinacea (angustifolia), Eupatorium Perfoliatum, Thuja Occidentalis, Viscum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA WHOLE; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>3; 3; 12; 12; 3; 6; 3; 3</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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve. ■ symptoms of yeast infection ■ itching ■ burning ■ discharge ■ odor*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0029-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70163-0029-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0029-1) </PackageDescription>
<NDC11Code>70163-0029-02</NDC11Code>
<ProductNDC>70163-0029</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tree Pollen</ProprietaryName>
<NonProprietaryName>Acer Negundo, Acer Rubrum, Adrenalinum, Allium Cepa, Arsenicum Iodatum, Betula Nigra, Euphrasia Officinalis, Fraxinus Americana, Histaminum Hydrochloricum, Ligustrum Vulgare, Liquidambar Styraciflua, Morus Alba, Pinus Strobus, Populus Deltoides, Quercus Rubra, Sabadilla, Salix Nigra, Sanguinaria Canadensis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260304</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; EPINEPHRINE; ONION; ARSENIC TRIIODIDE; BETULA NIGRA POLLEN; EUPHRASIA STRICTA; FRAXINUS AMERICANA POLLEN; HISTAMINE DIHYDROCHLORIDE; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MORUS ALBA POLLEN; PINUS STROBUS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; SCHOENOCAULON OFFICINALE SEED; SALIX NIGRA POLLEN; SANGUINARIA CANADENSIS ROOT</SubstanceName>
<StrengthNumber>12; 12; 6; 6; 6; 12; 6; 12; 12; 12; 12; 12; 12; 12; 12; 6; 12; 6</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</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [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], 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], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve allergy symptoms. ■ congestion ■ headache ■ itchy, watery eyes ■ sneezing*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0030-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70163-0030-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0030-1) </PackageDescription>
<NDC11Code>70163-0030-02</NDC11Code>
<ProductNDC>70163-0030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinufix</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis, Antimonium Tartaricum, Kali Bichromicum, Mercurius Iodatus Ruber, Spongia Tosta, Hepar Sulphuris Calcareum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260422</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG; ANTIMONY POTASSIUM TARTRATE; POTASSIUM DICHROMATE; MERCURIC IODIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; CALCIUM SULFIDE</SubstanceName>
<StrengthNumber>6; 6; 6; 12; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve. ■ sinus symptoms ■ sinus headache ■ nasal congestion ■ sinus pressure ■ sneezing*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0031-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70163-0031-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0031-1) </PackageDescription>
<NDC11Code>70163-0031-02</NDC11Code>
<ProductNDC>70163-0031</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollen Hayfever</ProprietaryName>
<NonProprietaryName>Adrenalinum, Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Iodatum, Mugwort Pollen (artemisia Vulgaris), Bellis Perennis, Brassica Spp, Chenopodium Album, Euphrasia Officinalis, Histaminum Hydrochloricum, Alfalfa Pollen (medicago Sativa), Phleum Pratense, Yellow Dock Pollen (rumex Crispus), Sabadilla, Silicea, Goldenrod Pollen (solidago Canadensis), Dandelion Pollen (taraxacum Officinale), Red Clover Pollen (trifolium Pratense), Xanthium Strumarium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260505</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>EPINEPHRINE; ONION; AMBROSIA ARTEMISIIFOLIA WHOLE; ARSENIC TRIIODIDE; ARTEMISIA VULGARIS POLLEN; BELLIS PERENNIS WHOLE; BRASSICA RAPA SUBSP. OLEIFERA POLLEN; CHENOPODIUM ALBUM POLLEN; EUPHRASIA STRICTA; HISTAMINE DIHYDROCHLORIDE; MEDICAGO SATIVA POLLEN; PHLEUM PRATENSE POLLEN; RUMEX CRISPUS POLLEN; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SOLIDAGO CANADENSIS POLLEN; TARAXACUM OFFICINALE POLLEN; TRIFOLIUM PRATENSE POLLEN; XANTHIUM STRUMARIUM POLLEN</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 12; 12; 12; 12; 6; 12; 12; 12; 12; 6; 12; 12; 12; 12; 12</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</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [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], 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 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], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve allergy symptoms. ■ runny nose ■ congestion ■ headache ■ itchy, watery eyes, ■ sneezing*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0033-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (70163-0033-2) / 125 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (70163-0033-1) </PackageDescription>
<NDC11Code>70163-0033-02</NDC11Code>
<ProductNDC>70163-0033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>A Plus Attention</ProprietaryName>
<NonProprietaryName>Baryta Carbonica, Calcarea Phosphorica, Silicea, Gelsemium Sempervirens, Nux Vomica, Sinapis Nigra</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260324</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; SILICON DIOXIDE; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; BLACK MUSTARD SEED</SubstanceName>
<StrengthNumber>10; 10; 10; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve ■ poor concentration ■ overactive mind ■ restlessness*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0034-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70163-0034-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0034-1) </PackageDescription>
<NDC11Code>70163-0034-02</NDC11Code>
<ProductNDC>70163-0034</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Adrenal Support</ProprietaryName>
<NonProprietaryName>Adrenalinum, Argentum Nitricum, Berberis Vulgaris, Natrum Muriaticum, Oleum Morrhuae, Petroleum, Vanadium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260324</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>EPINEPHRINE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; SODIUM CHLORIDE; COD LIVER OIL; KEROSENE; VANADIUM</SubstanceName>
<StrengthNumber>6; 10; 6; 10; 12; 12; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help to provide temporary glandular support for symptoms of. ■ low energy ■ low metabolism ■ inflammation ■ stress. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0035-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70163-0035-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0035-1) </PackageDescription>
<NDC11Code>70163-0035-02</NDC11Code>
<ProductNDC>70163-0035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Care</ProprietaryName>
<NonProprietaryName>Adrenalinum, Ragweed, Pollen (ambrosia Artemisiaefolia), Apis Mellifica, Echinacea (angustifolia), Histaminum Hydrochloricum, Ledum Palustre, Lycopodium Clavatum, Natrum Muriaticum, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260323</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>EPINEPHRINE; AMBROSIA ARTEMISIIFOLIA POLLEN; APIS MELLIFERA; ECHINACEA ANGUSTIFOLIA WHOLE; HISTAMINE DIHYDROCHLORIDE; RHODODENDRON TOMENTOSUM LEAFY TWIG; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SULFUR</SubstanceName>
<StrengthNumber>6; 6; 6; 4; 12; 8; 6; 8; 6</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</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [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], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve allergy symptoms of ■ nasal and sinus congestion ■ runny nose ■ skin irritations ■ sneezing ■ watery eyes*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0036-2</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (70163-0036-2) / 120 mL in 1 BOTTLE, GLASS (70163-0036-1) </PackageDescription>
<NDC11Code>70163-0036-02</NDC11Code>
<ProductNDC>70163-0036</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cough And Mucus</ProprietaryName>
<NonProprietaryName>Antimonium Tartaricum, Euphrasia Officinalis, Hepar Sulphuris Calcareum, Hydrastis Canadensis, Kali Bichromicum, Pulsatilla (pratensis), Stannum Metallicum, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260323</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; EUPHRASIA STRICTA; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; TIN; SULFUR</SubstanceName>
<StrengthNumber>6; 6; 12; 5; 12; 6; 12; 12</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</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve ■ chest congestion ■ hacking cough ■ thick mucus in chest, throat and nose*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0039-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70163-0039-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0039-1) </PackageDescription>
<NDC11Code>70163-0039-02</NDC11Code>
<ProductNDC>70163-0039</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uti Care</ProprietaryName>
<NonProprietaryName>Barosma (betulina), Dulcamara, Equisetum Hyemale, Terebinthina, Sarsaparilla (smilax Regelii) Triticum Repens</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260320</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>AGATHOSMA BETULINA LEAF; SOLANUM DULCAMARA TOP; EQUISETUM HYEMALE WHOLE; TURPENTINE OIL; SMILAX ORNATA ROOT; ELYMUS REPENS ROOT</SubstanceName>
<StrengthNumber>5; 3; 6; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve. ■ bladder symptoms ■ urge to urinate ■ frequent urination ■ painful urination. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0040-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70163-0040-2) / 30 mL in 1 BOTTLE, DROPPER (70163-0040-1) </PackageDescription>
<NDC11Code>70163-0040-02</NDC11Code>
<ProductNDC>70163-0040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu Relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Allium Cepa, Echinacea (angustifolia), Euphrasia Officinalis, Gelsemium Sempervirens, Sanguinaria Canadensis, Sticta Pulmonaria</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260323</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>ACONITUM NAPELLUS WHOLE; ONION; ECHINACEA ANGUSTIFOLIA WHOLE; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; SANGUINARIA CANADENSIS ROOT; LOBARIA PULMONARIA</SubstanceName>
<StrengthNumber>3; 6; 3; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve. ■ congestion ■ cough ■ nausea ■ sneezing ■ runny nose ■ headache ■ body ache*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70163-0047-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (70163-0047-2) / 120 TABLET in 1 BOTTLE, PLASTIC (70163-0047-1) </PackageDescription>
<NDC11Code>70163-0047-02</NDC11Code>
<ProductNDC>70163-0047</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anxiety Relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Argentum Nitricum, Arsenicum Album, Aurum Metallicum, Gelsemium Sempervirens, Hyoscyamus Niger, Ignatia Amara, Kali Carbonicum, Moschus, Natrum Muriaticum, Piper Methysticum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NaturalCare</LabelerName>
<SubstanceName>ACONITUM NAPELLUS WHOLE; SILVER NITRATE; ARSENIC TRIOXIDE; GOLD; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; SODIUM CHLORIDE; PIPER METHYSTICUM ROOT</SubstanceName>
<StrengthNumber>9; 8; 9; 8; 8; 6; 6; 12; 12; 6; 7</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help temporarily relieve ■ occasional minor anxiety ■ fear ■ anguish ■ stress and worry of everyday life ■ nervousness*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0024-5747-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0024-5747-02) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5747-02</NDC11Code>
<ProductNDC>0024-5747</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adlyxin</ProprietaryName>
<NonProprietaryName>Lixisenatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20160727</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208471</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>LIXISENATIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5831-02</NDCCode>
<PackageDescription>2 INJECTION in 1 CARTON (0024-5831-02)</PackageDescription>
<NDC11Code>00024-5831-02</NDC11Code>
<ProductNDC>0024-5831</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvi-q</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20121115</StartMarketingDate>
<EndMarketingDate>20161231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201739</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0024-5833-02</NDCCode>
<PackageDescription>2 INJECTION in 1 CARTON (0024-5833-02)</PackageDescription>
<NDC11Code>00024-5833-02</NDC11Code>
<ProductNDC>0024-5833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvi-q</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20121115</StartMarketingDate>
<EndMarketingDate>20161231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201739</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0024-5862-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0024-5862-01) / 1.2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00024-5862-01</NDC11Code>
<ProductNDC>0024-5862</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mozobil</ProprietaryName>
<NonProprietaryName>Plerixafor</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20130901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022311</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>PLERIXAFOR</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>mg/1.2mL</StrengthUnit>
<Pharm_Classes>Hematopoietic Stem Cell Mobilizer [EPC], Increased Hematopoietic Stem Cell Mobilization [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).</IndicationAndUsage>
<Description>Mozobil (plerixafor) injection is a sterile, preservative-free, clear, colorless to pale-yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor. Each single-dose vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required. Plerixafor is a hematopoietic stem cell mobilizer with a chemical name 1,4-Bis((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzene. It has the molecular formula C28H54N8. The molecular weight of plerixafor is 502.79 g/mol. The structural formula is provided in Figure 1. Figure 1: Structural Formula. Plerixafor is a white to off-white crystalline solid. It is hygroscopic. Plerixafor has a typical melting point of 131.5°C. The partition coefficient of plerixafor between 1-octanol and pH 7 aqueous buffer is <0.1.</Description>
</NDC>
<NDC>
<NDCCode>0024-5871-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0024-5871-02) / 3 mL in 1 SYRINGE (0024-5871-00) </PackageDescription>
<NDC11Code>00024-5871-02</NDC11Code>
<ProductNDC>0024-5871</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Toujeo Max</ProprietaryName>
<NonProprietaryName>Insulin Glargine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150215</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA206538</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>0024-5901-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5901-02) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5901-02</NDC11Code>
<ProductNDC>0024-5901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRALUENT® is indicated: 1 To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease., 2 As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C., 3 As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C., 4 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.</IndicationAndUsage>
<Description>Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0024-5902-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (0024-5902-02) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5902-02</NDC11Code>
<ProductNDC>0024-5902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRALUENT® is indicated: 1 To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease., 2 As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C., 3 As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C., 4 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.</IndicationAndUsage>
<Description>Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0024-5903-02</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0024-5903-02) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5903-02</NDC11Code>
<ProductNDC>0024-5903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5904-02</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0024-5904-02) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5904-02</NDC11Code>
<ProductNDC>0024-5904</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5908-01</NDCCode>
<PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5908-01) / 1.14 mL in 1 SYRINGE (0024-5908-00) </PackageDescription>
<NDC11Code>00024-5908-01</NDC11Code>
<ProductNDC>0024-5908</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kevzara</ProprietaryName>
<NonProprietaryName>Sarilumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170522</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761037</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>SARILUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1.14mL</StrengthUnit>
<Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170522</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
<Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
</NDC>
</NDCList>