{
"NDC": [
{
"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": "70163-0010-2",
"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": "70163-0024-2",
"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": "70163-0025-2",
"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": "70163-0030-2",
"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": "10210-0029-2",
"PackageDescription": "3 TUBE in 1 BLISTER PACK (10210-0029-2) / 10 g in 1 TUBE",
"NDC11Code": "10210-0029-02",
"ProductNDC": "10210-0029",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carmex Daily Care Moisturizing Lip Balm Fresh Cherry Spf 15",
"NonProprietaryName": "Octinoxate, Oxybenzone",
"DosageFormName": "SALVE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Carma Laboratories, Inc.",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": "75; 40",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2023-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against sunburn and chapped lips. higher SPF gives more sunburn protection."
},
{
"NDCCode": "11822-0029-2",
"PackageDescription": "170 BLISTER PACK in 1 CARTON (11822-0029-2) / 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "11822-0029-02",
"ProductNDC": "11822-0029",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20160730",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076775",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160730",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "15631-0029-2",
"PackageDescription": "400 PELLET in 1 PACKAGE (15631-0029-2)",
"NDC11Code": "15631-0029-02",
"ProductNDC": "15631-0029",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ammonium Muriaticum",
"NonProprietaryName": "Ammonium Muriaticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150906",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "AMMONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "17856-0029-1",
"PackageDescription": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0029-1) > 10 mL in 1 CUP, UNIT-DOSE (17856-0029-2) ",
"NDC11Code": "17856-0029-01",
"ProductNDC": "17856-0029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20020605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075714",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220926",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Inactive Ingredients: alcohol free lemon lime flavor, citric acid anhydrous, FD&C Yellow No. 6, hypromellose, orange flavor, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose, vanillin, and xanthan gum. It may contain 10% citric acid solution or 10% sodium citrate solution to adjust pH between 3.0 and 5.0."
},
{
"NDCCode": "43596-0029-2",
"PackageDescription": "1 TUBE in 1 BOX (43596-0029-2) > 4 g in 1 TUBE (43596-0029-1)",
"NDC11Code": "43596-0029-02",
"ProductNDC": "43596-0029",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Hd Longwear Long-lasting High-definition Color Spf 20",
"ProprietaryNameSuffix": "Fucsia Delirio - Pink",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170127",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".068",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "43689-0029-2",
"PackageDescription": "51 g in 1 JAR (43689-0029-2) ",
"NDC11Code": "43689-0029-02",
"ProductNDC": "43689-0029",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain And Itch Relief",
"NonProprietaryName": "Daphne Mezereum Bark, Gelsemium Sempervirens Root",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170706",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Magni Group",
"SubstanceName": "DAPHNE MEZEREUM BARK; GELSEMIUM SEMPERVIRENS ROOT",
"StrengthNumber": "6; 6",
"StrengthUnit": "[hp_X]/51g; [hp_X]/51g",
"Status": "Deprecated",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170706",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of pain, itch, and minor skin irritation."
},
{
"NDCCode": "45932-0029-2",
"PackageDescription": "10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (45932-0029-2)",
"NDC11Code": "45932-0029-02",
"ProductNDC": "45932-0029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091377",
"LabelerName": "Xellia Pharmaceuticals, ApS",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC],Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by Streptococcus viridans or S. bovis. For endocarditis caused by enterococci (e.g.,E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection oftherapy. The parenteral form of Vancomycin Hydrochloride for Injection, USP may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infection.",
"Description": "Vancomycin Hydrochloride for Injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE.Vancomycin Hydrochloride for Injection, USP is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. Vancomycin hydrochloride has the following structural formula. C66H75Cl2N9O24.HCl 1485.73."
},
{
"NDCCode": "47632-0029-2",
"PackageDescription": "690 L in 1 CYLINDER (47632-0029-2) ",
"NDC11Code": "47632-0029-02",
"ProductNDC": "47632-0029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19881215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205767",
"LabelerName": "O.E. Meyer Company",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2024-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19881215",
"SamplePackage": "N"
},
{
"NDCCode": "49288-0029-1",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0029-1)",
"NDC11Code": "49288-0029-01",
"ProductNDC": "49288-0029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alfalfa Pollen",
"NonProprietaryName": "Alfalfa Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "MEDICAGO SATIVA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49288-0029-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0029-2)",
"NDC11Code": "49288-0029-02",
"ProductNDC": "49288-0029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alfalfa Pollen",
"NonProprietaryName": "Alfalfa Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "MEDICAGO SATIVA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>70163-0010-2</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>70163-0024-2</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>70163-0025-2</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>70163-0030-2</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>10210-0029-2</NDCCode>
<PackageDescription>3 TUBE in 1 BLISTER PACK (10210-0029-2) / 10 g in 1 TUBE</PackageDescription>
<NDC11Code>10210-0029-02</NDC11Code>
<ProductNDC>10210-0029</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carmex Daily Care Moisturizing Lip Balm Fresh Cherry Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Oxybenzone</NonProprietaryName>
<DosageFormName>SALVE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Carma Laboratories, Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>75; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against sunburn and chapped lips. higher SPF gives more sunburn protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0029-2</NDCCode>
<PackageDescription>170 BLISTER PACK in 1 CARTON (11822-0029-2) / 1 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11822-0029-02</NDC11Code>
<ProductNDC>11822-0029</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160730</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076775</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160730</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0029-2</NDCCode>
<PackageDescription>400 PELLET in 1 PACKAGE (15631-0029-2)</PackageDescription>
<NDC11Code>15631-0029-02</NDC11Code>
<ProductNDC>15631-0029</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ammonium Muriaticum</ProprietaryName>
<NonProprietaryName>Ammonium Muriaticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150906</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>AMMONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17856-0029-1</NDCCode>
<PackageDescription>72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0029-1) > 10 mL in 1 CUP, UNIT-DOSE (17856-0029-2) </PackageDescription>
<NDC11Code>17856-0029-01</NDC11Code>
<ProductNDC>17856-0029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075714</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).</IndicationAndUsage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Inactive Ingredients: alcohol free lemon lime flavor, citric acid anhydrous, FD&C Yellow No. 6, hypromellose, orange flavor, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose, vanillin, and xanthan gum. It may contain 10% citric acid solution or 10% sodium citrate solution to adjust pH between 3.0 and 5.0.</Description>
</NDC>
<NDC>
<NDCCode>43596-0029-2</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (43596-0029-2) > 4 g in 1 TUBE (43596-0029-1)</PackageDescription>
<NDC11Code>43596-0029-02</NDC11Code>
<ProductNDC>43596-0029</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Hd Longwear Long-lasting High-definition Color Spf 20</ProprietaryName>
<ProprietaryNameSuffix>Fucsia Delirio - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170127</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.068</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43689-0029-2</NDCCode>
<PackageDescription>51 g in 1 JAR (43689-0029-2) </PackageDescription>
<NDC11Code>43689-0029-02</NDC11Code>
<ProductNDC>43689-0029</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain And Itch Relief</ProprietaryName>
<NonProprietaryName>Daphne Mezereum Bark, Gelsemium Sempervirens Root</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170706</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Magni Group</LabelerName>
<SubstanceName>DAPHNE MEZEREUM BARK; GELSEMIUM SEMPERVIRENS ROOT</SubstanceName>
<StrengthNumber>6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/51g; [hp_X]/51g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of pain, itch, and minor skin irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45932-0029-2</NDCCode>
<PackageDescription>10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (45932-0029-2)</PackageDescription>
<NDC11Code>45932-0029-02</NDC11Code>
<ProductNDC>45932-0029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091377</ApplicationNumber>
<LabelerName>Xellia Pharmaceuticals, ApS</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC],Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by Streptococcus viridans or S. bovis. For endocarditis caused by enterococci (e.g.,E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection oftherapy. The parenteral form of Vancomycin Hydrochloride for Injection, USP may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infection.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE.Vancomycin Hydrochloride for Injection, USP is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. Vancomycin hydrochloride has the following structural formula. C66H75Cl2N9O24.HCl 1485.73.</Description>
</NDC>
<NDC>
<NDCCode>47632-0029-2</NDCCode>
<PackageDescription>690 L in 1 CYLINDER (47632-0029-2) </PackageDescription>
<NDC11Code>47632-0029-02</NDC11Code>
<ProductNDC>47632-0029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19881215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205767</ApplicationNumber>
<LabelerName>O.E. Meyer Company</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49288-0029-1</NDCCode>
<PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0029-1)</PackageDescription>
<NDC11Code>49288-0029-01</NDC11Code>
<ProductNDC>49288-0029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alfalfa Pollen</ProprietaryName>
<NonProprietaryName>Alfalfa Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>MEDICAGO SATIVA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0029-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0029-2)</PackageDescription>
<NDC11Code>49288-0029-02</NDC11Code>
<ProductNDC>49288-0029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alfalfa Pollen</ProprietaryName>
<NonProprietaryName>Alfalfa Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>MEDICAGO SATIVA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
</NDCList>