{
"NDC": [
{
"NDCCode": "57955-1602-6",
"PackageDescription": "473 mL in 1 BOTTLE (57955-1602-6) ",
"NDC11Code": "57955-1602-06",
"ProductNDC": "57955-1602",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aquaflora Phase Ii",
"NonProprietaryName": "Candida Albicans",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180403",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc",
"SubstanceName": "CANDIDA ALBICANS",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/473mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180403",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of Candida albicans overgrowth symptoms, such as: 1 reactions on skin, 2 thick, dry, and cracked tongue, 3 bad breath, 4 dry lips and mouth, 5 constipation, 6 eczema."
},
{
"NDCCode": "57955-1601-6",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (57955-1601-6) ",
"NDC11Code": "57955-1601-06",
"ProductNDC": "57955-1601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aquaflora Phase I",
"NonProprietaryName": "Candida Albicans",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180320",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc",
"SubstanceName": "CANDIDA ALBICANS",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/473mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180320",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of Candida albicans overgrowt symptoms, such as: 1 reactions on skin, 2 thick, dry, and cracked tongue, 3 bad breath, 4 dry lips and mouth, 5 constipation, 6 eczema."
},
{
"NDCCode": "57955-1603-6",
"PackageDescription": "473 mL in 1 BOTTLE (57955-1603-6) ",
"NDC11Code": "57955-1603-06",
"ProductNDC": "57955-1603",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aqua Flora High Potency",
"NonProprietaryName": "Allium Sativum 6c, Candida Albicans 100c.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180214",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc",
"SubstanceName": "GARLIC; ALOE; CANDIDA ALBICANS",
"StrengthNumber": "6; 6; 100",
"StrengthUnit": "[hp_C]/473mL; [hp_C]/473mL; [hp_C]/473mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180214",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of Candida albicans overgrowth symptoms, such as: 1 reactions on skin, 2 thick, dry, and cracked tongue, 3 bad breath, 4 dry lips and mouth, 5 constipation, 6 eczema, 7 impatience, 8 emotional sensitivity."
},
{
"NDCCode": "57955-4020-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-4020-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-4020-01",
"ProductNDC": "57955-4020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Irritable Bowelcare",
"NonProprietaryName": "Aloe Socotrina, Carbo Vegetabilis, Chamomilla, Cinchona Officinalis, Collinsonia Canadensis, Colocynthis, Croton Tiglium, Gelsemium Sempervirens, Gratiola Officinalis, Nux Vomica,phosphoricum Acidum, Podophyllum Peltatum And Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110213",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALOE; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; GELSEMIUM SEMPERVIRENS ROOT; GRATIOLA OFFICINALIS; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; mL/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57955-4022-1",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (57955-4022-1) > 29.6 mL in 1 BOTTLE, PUMP",
"NDC11Code": "57955-4022-01",
"ProductNDC": "57955-4022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heartburncare",
"NonProprietaryName": "Abies Nigra, Condurango, Conium Maculatum, Iris Versicolor, Magnesia Carbonica, Robinia Pseudoacacia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120213",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "PICEA MARIANA RESIN; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; IRIS VERSICOLOR ROOT; MAGNESIUM CARBONATE; ROBINIA PSEUDOACACIA BARK",
"StrengthNumber": "10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: : 1 acid reflux, 2 burping, 3 heartburn, 4 sour stomach, 5 indigestion, 6 stomach spasms, 7 nausea, 8 stomach gas and bloating, 9 pain in esophagus."
},
{
"NDCCode": "57955-4043-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-4043-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-4043-01",
"ProductNDC": "57955-4043",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergycare",
"NonProprietaryName": "Llium Cepa, Ambrosia Artemisiaefolia, Arum Triphyllum, Arundo Mauritanica, Cortisone Aceticum, Euphrasia Officinalis, Galphimia Glauca, Histaminum Hydrochloricum, Kali Muriaticum, Natrum Muriaticum, Rna, Sabadilla And Wyethia Helenioides",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120511",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ONION; AMBROSIA ARTEMISIIFOLIA; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; WYETHIA HELENIOIDES ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57955-4199-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-4199-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-4199-01",
"ProductNDC": "57955-4199",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Multi-strain Flucare",
"NonProprietaryName": "Anas Barbariae, Hepatis Et Cordis Extractum, Baptisia Tinctoria, Bryonia, Cinchona Officinalis, Dulcamara, Echinacea Purpurea, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Influenzinum, Phytolacca Decandra, Rhus Toxicodendron, Sarcolacticum Acidum, Sulphur, Wyethia Helenioides, Zincum Aceticum, Zincum Muriaticum, Zincum Oxydatum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; WYETHIA HELENIOIDES ROOT; ZINC ACETATE ANHYDROUS; ZINC CHLORIDE; ZINC OXIDE",
"StrengthNumber": "35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_C]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of flu symptoms such as: : 1 fever, 2 chills, 3 night sweats, 4 nausea , 5 vomiting, 6 headache, 7 sneezing, 8 runny nose, 9 nasal congestion, 10 sore throat, 11 swollen tonsils, 12 cough, 13 diarrhea, 14 body aches, 15 fatigue."
},
{
"NDCCode": "57955-7019-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-7019-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-7019-01",
"ProductNDC": "57955-7019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Constipation Symptom Formula",
"NonProprietaryName": "Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130220",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms of constipation: 1 irregularity, 2 hard, dry stools, 3 great straining, 4 rumbling and bloated bowels, 5 mucus in stools, 6 associated headache."
},
{
"NDCCode": "57955-7020-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-7020-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-7020-01",
"ProductNDC": "57955-7020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diarrhea Symptom Formula",
"NonProprietaryName": "Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Croton Tiglium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130220",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms of diarrhea: 1 loose and watery stools, 2 cramps, 3 gas and bloating, 4 mucus in stools, 5 jelly-like stool, 6 sudden evacuation, 7 intestinal gurgling, 8 involuntary stools, 9 diarrhea caused by certain foods or emotional excitement."
},
{
"NDCCode": "57955-7023-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-7023-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-7023-01",
"ProductNDC": "57955-7023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hemorrhoid Symptom Formula",
"NonProprietaryName": "Aesculus Hippocastanum, Aloe Socotrina, Collinsonia Canadensis, Hamamelis Virginiana, Muriaticum Acidum, Nux Vomica, Paeonia Officinalis, Ratanhia, Sepia, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130218",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "HORSE CHESTNUT; ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT; SEPIA OFFICINALIS JUICE; SULFUR",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary releif of hemorrhold symptoms: 1 burning or aching in anus, 2 rectal pain and itching, 3 backache, 4 constipation, 5 blind or protruding hemorrhoids."
},
{
"NDCCode": "57955-7024-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-7024-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-7024-01",
"ProductNDC": "57955-7024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Indigestion Symptom Formula",
"NonProprietaryName": "Antimonium Crudum, Argentum Nitricum, Carbo Vegetabilis, Chelidonium Majus, Cinchona Officinalis, Graphites, Hydrastis Canadensis, Ipecacuanha, Kali Carbonicum, Lycopodium Clavatum, Nux Vomica, Pulsatilla",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130215",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ANTIMONY TRISULFIDE; SILVER NITRATE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms following food or drink consumption: 1 gas, 2 bloating, 3 belching, 4 nausea, 5 intestinal distress, 6 hiccups, 7 flatulence, 8 sleepiness."
},
{
"NDCCode": "57955-7145-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-7145-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-7145-01",
"ProductNDC": "57955-7145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Cough Symptom Formula",
"NonProprietaryName": "Aconitum Napellus, Bromium, Coccus Cacti, Corallium Rubrum, Cuprum Metallicum, Drosera, Hepar Sulphuris Calcareum, Iodium, Mephitis Mephitica And Spongia Tosta",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130211",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ACONITUM NAPELLUS; BROMINE; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; COPPER; DROSERA ROTUNDIFOLIA; CALCIUM SULFIDE; IODINE; MEPHITIS MEPHITIS ANAL GLAND FLUID; SPONGIA OFFICINALIS SKELETON, ROASTED",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for relief of minor cough symptoms from the common cold or inhaled irritants: 1 cough with mucus, 2 dry cough, 3 rapid, barking cough, 4 wheezing cough."
},
{
"NDCCode": "57955-7225-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-7225-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-7225-01",
"ProductNDC": "57955-7225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stye Symptom Formula",
"NonProprietaryName": "Apis Mellifica, Calcarea Picrata, Graphites, Hepar Sulphuris Calcareum, Juglans Regia, Lycopodium Clavatum, Pulsatilla, Silicea, Staphysagria, Sulfur, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "APIS MELLIFERA; CALCIUM PICRATE; GRAPHITE; CALCIUM SULFIDE; JUGLANS REGIA WHOLE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief from symptoms of styes or hordeolums: 1 swollen eyelids, 2 eyelid discomfort, 3 redness, 4 sensitivity to touch, 5 inflammation, 6 itching, 7 stinging."
},
{
"NDCCode": "57955-7295-2",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-7295-2) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-7295-02",
"ProductNDC": "57955-7295",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ear Ringing Symptom Formula",
"NonProprietaryName": "Arnica Montana, Calcarea Carbonica, Chenopodium Anthelminticum, Chininum Salicylicum, Cimicifuga Racemosa, Coffea Tosta, Kali Iodatum, Kalmia Latifolia, Magnesia Carbonica, Manganum Aceticum, Manganum Carbonicum, Mercurius Vivus, Natrum Salicylicum, Salicylicum Acidum, Thiosinaminum, Thyroidinum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131209",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; QUININE SALICYLATE; BLACK COHOSH; COFFEA ARABICA SEED, ROASTED; POTASSIUM IODIDE; KALMIA LATIFOLIA LEAF; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; MANGANESE CARBONATE; MERCURY; SODIUM SALICYLATE; SALICYLIC ACID; ALLYLTHIOUREA; THYROID, UNSPECIFIED",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptomic relief of ear sounds: 1 buzzing, roaring, ringing, and whistling, 2 sensitivity to noise."
},
{
"NDCCode": "57955-8058-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-8058-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-8058-01",
"ProductNDC": "57955-8058",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gallbladder Symptom Formula",
"NonProprietaryName": "Berberis Vulgaris, Bryonia Alba, Carduus Marianus, Chelidonium Majus, Cholesterinum, Cinchona Officinalis, Colocynthis, Dioscorea Villosa, Lycopodium Clavatum And Natrum Sulphuricum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130220",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of minor gallbladder symptoms: 1 indigestion, 2 bloating, 3 gas, 4 bitter taste in mouth, 5 abdominal discomforts after eating."
},
{
"NDCCode": "57955-8300-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-8300-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-8300-01",
"ProductNDC": "57955-8300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Food Intolerances",
"NonProprietaryName": "Aethusa Cynapium, Calcarea Carbonica, Cucurbita Pepo, Semen, Gambogia, Histaminum Hydrochloricum, Hydrastis Canadensis, Lycopodium Clavatum, Natrum Carbonicum, Nitricum Acidum, Nux Vomica, Ovi Gallinae Pellicula, Phosphorus, Pulsatilla, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131104",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AETHUSA CYNAPIUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PUMPKIN SEED; GAMBOGE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; EGG SHELL MEMBRANE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms associated with food intolerances and sensitivities: 1 headache, 2 irritability, 3 stomach cramps and indigestion, 4 nausea, 5 gas, heartburn and bloating, 6 constipation, 7 diarrhea, 8 sensitivities to meat, fat, salt, dairy, starches and vegetables."
},
{
"NDCCode": "57955-8310-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-8310-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-8310-01",
"ProductNDC": "57955-8310",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pet Hair And Dander Allergies",
"NonProprietaryName": "Aralia Racemosa, Arsenicum Album, Histaminum Hydrochloricum, Nux Vomica, Oleum Animale, Phosphorus, Silicea, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131112",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; HISTAMINE DIHYDROCHLORIDE; STRYCHNOS NUX-VOMICA SEED; CERVUS ELAPHUS HORN OIL; PHOSPHORUS; SILICON DIOXIDE; SULFUR",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of minor allergy symptoms from pet hair, feathers and dander: skin irritations itchy, watery eyes sneezing, runny nose tickling cough hoarseness congestion."
},
{
"NDCCode": "57955-8315-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-8315-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-8315-01",
"ProductNDC": "57955-8315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Midwest Regional Allergies",
"NonProprietaryName": "Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium Cepa, Ambrosia Artemisiaefolia, Cichorium Intybus, Conium Maculatum, Cortisone Aceticum, Euphrasia Officinalis, Fagopyrum Esculentum, Galphimia Glauca, Hedera Helix, Histaminum Hydrochloricum, Kali Muriaticum, Mucosa Nasalis Suis, Natrum Muriaticum, Rna, Rumex Crispus, Sabadilla, Secale Cornutum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131104",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; AMBROSIA ARTEMISIIFOLIA; CHICORY ROOT; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; CLAVICEPS PURPUREA SCLEROTIUM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of allergy symptoms commonly experienced in IA, IL, IN, KS, MI, MN, MO, ND, NE, OH, SD, WI: 1 itchy, watery eyes, 2 runny nose, 3 sneezing, 4 sore throat, 5 sinus congestion, 6 cough, 7 stuffy nose, 8 fatigue, 9 itchy, irritated skin, 10 hoarseness, 11 headache."
},
{
"NDCCode": "57955-8325-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-8325-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-8325-01",
"ProductNDC": "57955-8325",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Northeast Regional Allergies",
"NonProprietaryName": "Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agraphis Nutans, Allium Cepa, Collinsonia Canadensis, Cortisone Aceticum, Euphrasia Officinalis, Galphimia Glauca, Histaminum Hydrochloricum, Kali Muriaticum, Mucosa Nasalis Suis, Natrum Muriaticum, Rna, Rumex Crispus, Sabadilla, Salvia Officinalis, Tanacetum Vulgare, Trifolium Pratense, Vinca Minor",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131104",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; HYACINTHOIDES NON-SCRIPTA; ONION; COLLINSONIA CANADENSIS ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; SAGE; TANACETUM VULGARE TOP; TRIFOLIUM PRATENSE FLOWER; VINCA MINOR",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of allergy symptoms commonly experienced in CT, MA, ME, NH, NJ, NY, PA, RI, VT: 1 itchy, watery eyes, 2 runny nose, 3 sneezing, 4 sore throat , 5 sinus congestion, 6 cough, 7 stuffy nose , 8 fatigue, 9 itchy, irritated skin, 10 hoarseness, 11 headache."
},
{
"NDCCode": "57955-8330-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-8330-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-8330-01",
"ProductNDC": "57955-8330",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pacific Regional Allergies",
"NonProprietaryName": "Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Alfalfa, Allium Cepa, Bellis Perennis, Conium Maculatum, Cortisone Aceticum, Equisetum Hyemale, Euphrasia Officinalis, Fagopyrum Esculentum, Galphimia Glauca, Histaminum Hydrochloricum, Kali Muriaticum, Millefolium, Mucosa Nasalis Suis, Natrum Muriaticum, Prunus Spinosa, Rna, Sabadilla, Solidago Virgaurea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131126",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ALFALFA; ONION; BELLIS PERENNIS; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EQUISETUM HYEMALE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; ACHILLEA MILLEFOLIUM; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PRUNUS SPINOSA FLOWER BUD; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of allergy symptoms commonly experienced in CA, OR, WA: 1 itchy, watery eyes, 2 runny nose, 3 sneezing, 4 sore throat, 5 sinus congestion, 6 cough, 7 stuffy nose, 8 fatigue, 9 itchy, irritated skin, 10 hoarseness, 11 headache."
},
{
"NDCCode": "57955-8345-1",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (57955-8345-1) > 29.6 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "57955-8345-01",
"ProductNDC": "57955-8345",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Southeast Regional Allergies",
"NonProprietaryName": "Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium Cepa, Alnus Serrulata, Carduus Benedictus, Cichorium Intybus, Cortisone Aceticum, Dolichos Pruriens, Euphrasia Officinalis, Galphimia Glauca, Histaminum Hydrochloricum, Juglans Cinerea, Kali Muriaticum, Mucosa Nasalis Suis, Nasturtium Aquaticum, Natrum Muriaticum, Rna, Rhus Toxicodendron, Sabadilla, Sassafras Officinale",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; ALNUS SERRULATA BARK; CENTAUREA BENEDICTA; CHICORY ROOT; CORTISONE ACETATE; MUCUNA PRURIENS FRUIT TRICHOME; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; NASTURTIUM OFFICINALE; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SASSAFRAS ALBIDUM ROOT BARK",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of allergy symptoms commonly experienced in AL, AR, DC, DE, FL, GA, KY, LA, MD, MS, NC, SC, TN, VA, WV: 1 itchy, watery eyes, 2 runny nose, 3 sneezing, 4 sore throat, 5 sinus congestion, 6 cough, 7 stuffy nose, 8 fatigue, 9 itchy, irritated skin, 10 hoarseness, 11 headache."
},
{
"NDCCode": "22840-1602-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-1602-2) ",
"NDC11Code": "22840-1602-02",
"ProductNDC": "22840-1602",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Alternaria Alternata",
"NonProprietaryName": "Alternaria Alternata",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "ALTERNARIA ALTERNATA",
"StrengthNumber": ".05",
"StrengthUnit": "g/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": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).",
"Description": "Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen."
},
{
"NDCCode": "22840-1602-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-1602-4) ",
"NDC11Code": "22840-1602-04",
"ProductNDC": "22840-1602",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Alternaria Alternata",
"NonProprietaryName": "Alternaria Alternata",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "ALTERNARIA ALTERNATA",
"StrengthNumber": ".05",
"StrengthUnit": "g/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": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).",
"Description": "Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen."
},
{
"NDCCode": "41167-1602-2",
"PackageDescription": "1 BOTTLE in 1 CARTON (41167-1602-2) / 85 g in 1 BOTTLE",
"NDC11Code": "41167-1602-02",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flexall Pain Relieving",
"NonProprietaryName": "Menthol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "19970101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Chattem, Inc.",
"SubstanceName": "MENTHOL",
"StrengthNumber": ".16",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2024-02-17",
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"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor pain associated with: 1 arthritis, 2 simple backache, 3 muscle strains, 4 sprains , 5 bruises, 6 cramps."
},
{
"NDCCode": "50090-1602-0",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (50090-1602-0) ",
"NDC11Code": "50090-1602-00",
"ProductNDC": "50090-1602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefaclor",
"NonProprietaryName": "Cefaclor",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065146",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CEFACLOR",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
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"IndicationAndUsage": "Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsule and other antibacterial drugs, Cefaclor Capsule 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 of therapy.",
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},
{
"NDCCode": "50090-1602-2",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (50090-1602-2) ",
"NDC11Code": "50090-1602-02",
"ProductNDC": "50090-1602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefaclor",
"NonProprietaryName": "Cefaclor",
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"RouteName": "ORAL",
"StartMarketingDate": "20080731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065146",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CEFACLOR",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2024-02-02",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150106",
"SamplePackage": "N",
"IndicationAndUsage": "Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsule and other antibacterial drugs, Cefaclor Capsule 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 of therapy.",
"Description": "Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN3O4SH2O and the molecular weight is 385.82. Each 250-mg capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) of anhydrous cefaclor and inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc. The 250 mg capsule shell contains gelatin, titanium dioxide, FD & C Blue No. 1, FD & C Red No. 3, and imprinting ink components: shellac, strong ammonia solution, potassium hydroxide, black iron oxide, .dehydrated alcohol, isopropyl alcohol, butyl alcohol and propylene glycol. Each 500-mg capsule contains cefaclor monohydrate equivalent to 500 mg (1.36 mmol) of anhydrous cefaclor and inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc. The 500 mg capsule shell contains gelatin, titanium dioxide, FD & C Blue No. 1, FD & C Red No. 3, FD & C Yellow No. 6, FD & C Red No. 40, and imprinting ink components: shellac, strong ammonia solution, titanium dioxide, FD & C Blue No. 1 aluminum lake, dehydrated alcohol, isopropyl alcohol, butyl alcohol and propylene glycol."
},
{
"NDCCode": "59469-313-10",
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"NDC11Code": "59469-0313-10",
"ProductNDC": "59469-313",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Opsonat",
"NonProprietaryName": "Silver Nitrate, Sulfuric Acid, Bellis Perennis, Lytta Vesicatoria, Gratiola Officinalis, Goldenseal, Lachesis Muta Venom, And Glechoma Hederacea Flowering Top",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20190624",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel GmbH",
"SubstanceName": "SILVER NITRATE; SULFURIC ACID; BELLIS PERENNIS WHOLE; LYTTA VESICATORIA; GRATIOLA OFFICINALIS WHOLE; GOLDENSEAL; LACHESIS MUTA VENOM; GLECHOMA HEDERACEA FLOWERING TOP",
"StrengthNumber": "6; 6; 1; 4; 4; 5; 8; 1602",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; mg/100mL",
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"LastUpdate": "2023-01-14",
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"IndicationAndUsage": "For relief of minor mucous membrane inflammation, such as the mouth. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
},
{
"NDCCode": "59469-313-40",
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"ProductTypeName": "HUMAN OTC DRUG",
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"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; mg/100mL",
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{
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"ProductNDC": "60681-1602",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pleo Leptu",
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"RouteName": "RECTAL",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sanum Kehlbeck GmbH & Co. KG",
"SubstanceName": "PROPIONIBACTERIUM AVIDUM",
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"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For temporary relief of cramped or aching muscles."
},
{
"NDCCode": "67046-1602-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-1602-3) ",
"NDC11Code": "67046-1602-03",
"ProductNDC": "67046-1602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abacavir",
"NonProprietaryName": "Abacavir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091560",
"LabelerName": "Coupler LLC",
"SubstanceName": "ABACAVIR SULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A1 Inhibitors [MoA], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-21",
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"StartMarketingDatePackage": "20210401",
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"IndicationAndUsage": "Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.",
"Description": "Abacavir sulfate, USP is a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate, USP is (1S,4R)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate, USP is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2H2SO4 and a molecular weight of 670.74 daltons. It has the following structural formula. Abacavir sulfate, USP is a white to off-white powder. Soluble in water, slightly soluble in methanol. It has an octanol per water (pH 3.3) partition coefficient (log P) of approximately 1 by UV-spectrometry at 25°C. Abacavir tablets, USP are for oral administration. Each tablet contains abacavir sulfate, USP equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The tablets are coated with opadry yellow which contains hypromellose, titanium dioxide, triacetin, iron oxide yellow, polysorbate 80. In vivo,abacavir sulfate, USP dissociates to its free base, abacavir. All dosages for abacavir sulfate, USP are expressed in terms of abacavir."
}
]
}
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<IndicationAndUsage>for temporary relief of Candida albicans overgrowth symptoms, such as: 1 reactions on skin, 2 thick, dry, and cracked tongue, 3 bad breath, 4 dry lips and mouth, 5 constipation, 6 eczema.</IndicationAndUsage>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aquaflora Phase I</ProprietaryName>
<NonProprietaryName>Candida Albicans</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180320</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc</LabelerName>
<SubstanceName>CANDIDA ALBICANS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/473mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of Candida albicans overgrowt symptoms, such as: 1 reactions on skin, 2 thick, dry, and cracked tongue, 3 bad breath, 4 dry lips and mouth, 5 constipation, 6 eczema.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-1603-6</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (57955-1603-6) </PackageDescription>
<NDC11Code>57955-1603-06</NDC11Code>
<ProductNDC>57955-1603</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aqua Flora High Potency</ProprietaryName>
<NonProprietaryName>Allium Sativum 6c, Candida Albicans 100c.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180214</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc</LabelerName>
<SubstanceName>GARLIC; ALOE; CANDIDA ALBICANS</SubstanceName>
<StrengthNumber>6; 6; 100</StrengthNumber>
<StrengthUnit>[hp_C]/473mL; [hp_C]/473mL; [hp_C]/473mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of Candida albicans overgrowth symptoms, such as: 1 reactions on skin, 2 thick, dry, and cracked tongue, 3 bad breath, 4 dry lips and mouth, 5 constipation, 6 eczema, 7 impatience, 8 emotional sensitivity.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-4020-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-4020-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-4020-01</NDC11Code>
<ProductNDC>57955-4020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Irritable Bowelcare</ProprietaryName>
<NonProprietaryName>Aloe Socotrina, Carbo Vegetabilis, Chamomilla, Cinchona Officinalis, Collinsonia Canadensis, Colocynthis, Croton Tiglium, Gelsemium Sempervirens, Gratiola Officinalis, Nux Vomica,phosphoricum Acidum, Podophyllum Peltatum And Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110213</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALOE; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; GELSEMIUM SEMPERVIRENS ROOT; GRATIOLA OFFICINALIS; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; mL/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57955-4022-1</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (57955-4022-1) > 29.6 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>57955-4022-01</NDC11Code>
<ProductNDC>57955-4022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heartburncare</ProprietaryName>
<NonProprietaryName>Abies Nigra, Condurango, Conium Maculatum, Iris Versicolor, Magnesia Carbonica, Robinia Pseudoacacia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120213</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>PICEA MARIANA RESIN; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; IRIS VERSICOLOR ROOT; MAGNESIUM CARBONATE; ROBINIA PSEUDOACACIA BARK</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: : 1 acid reflux, 2 burping, 3 heartburn, 4 sour stomach, 5 indigestion, 6 stomach spasms, 7 nausea, 8 stomach gas and bloating, 9 pain in esophagus.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-4043-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-4043-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-4043-01</NDC11Code>
<ProductNDC>57955-4043</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergycare</ProprietaryName>
<NonProprietaryName>Llium Cepa, Ambrosia Artemisiaefolia, Arum Triphyllum, Arundo Mauritanica, Cortisone Aceticum, Euphrasia Officinalis, Galphimia Glauca, Histaminum Hydrochloricum, Kali Muriaticum, Natrum Muriaticum, Rna, Sabadilla And Wyethia Helenioides</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120511</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ONION; AMBROSIA ARTEMISIIFOLIA; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; WYETHIA HELENIOIDES ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57955-4199-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-4199-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-4199-01</NDC11Code>
<ProductNDC>57955-4199</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Multi-strain Flucare</ProprietaryName>
<NonProprietaryName>Anas Barbariae, Hepatis Et Cordis Extractum, Baptisia Tinctoria, Bryonia, Cinchona Officinalis, Dulcamara, Echinacea Purpurea, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Influenzinum, Phytolacca Decandra, Rhus Toxicodendron, Sarcolacticum Acidum, Sulphur, Wyethia Helenioides, Zincum Aceticum, Zincum Muriaticum, Zincum Oxydatum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120327</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; WYETHIA HELENIOIDES ROOT; ZINC ACETATE ANHYDROUS; ZINC CHLORIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_C]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of flu symptoms such as: : 1 fever, 2 chills, 3 night sweats, 4 nausea , 5 vomiting, 6 headache, 7 sneezing, 8 runny nose, 9 nasal congestion, 10 sore throat, 11 swollen tonsils, 12 cough, 13 diarrhea, 14 body aches, 15 fatigue.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7019-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-7019-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-7019-01</NDC11Code>
<ProductNDC>57955-7019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Constipation Symptom Formula</ProprietaryName>
<NonProprietaryName>Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms of constipation: 1 irregularity, 2 hard, dry stools, 3 great straining, 4 rumbling and bloated bowels, 5 mucus in stools, 6 associated headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7020-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-7020-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-7020-01</NDC11Code>
<ProductNDC>57955-7020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diarrhea Symptom Formula</ProprietaryName>
<NonProprietaryName>Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Croton Tiglium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms of diarrhea: 1 loose and watery stools, 2 cramps, 3 gas and bloating, 4 mucus in stools, 5 jelly-like stool, 6 sudden evacuation, 7 intestinal gurgling, 8 involuntary stools, 9 diarrhea caused by certain foods or emotional excitement.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7023-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-7023-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-7023-01</NDC11Code>
<ProductNDC>57955-7023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hemorrhoid Symptom Formula</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Aloe Socotrina, Collinsonia Canadensis, Hamamelis Virginiana, Muriaticum Acidum, Nux Vomica, Paeonia Officinalis, Ratanhia, Sepia, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130218</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>HORSE CHESTNUT; ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT; SEPIA OFFICINALIS JUICE; SULFUR</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary releif of hemorrhold symptoms: 1 burning or aching in anus, 2 rectal pain and itching, 3 backache, 4 constipation, 5 blind or protruding hemorrhoids.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7024-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-7024-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-7024-01</NDC11Code>
<ProductNDC>57955-7024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Indigestion Symptom Formula</ProprietaryName>
<NonProprietaryName>Antimonium Crudum, Argentum Nitricum, Carbo Vegetabilis, Chelidonium Majus, Cinchona Officinalis, Graphites, Hydrastis Canadensis, Ipecacuanha, Kali Carbonicum, Lycopodium Clavatum, Nux Vomica, Pulsatilla</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; SILVER NITRATE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms following food or drink consumption: 1 gas, 2 bloating, 3 belching, 4 nausea, 5 intestinal distress, 6 hiccups, 7 flatulence, 8 sleepiness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7145-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-7145-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-7145-01</NDC11Code>
<ProductNDC>57955-7145</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Cough Symptom Formula</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Bromium, Coccus Cacti, Corallium Rubrum, Cuprum Metallicum, Drosera, Hepar Sulphuris Calcareum, Iodium, Mephitis Mephitica And Spongia Tosta</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130211</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; BROMINE; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; COPPER; DROSERA ROTUNDIFOLIA; CALCIUM SULFIDE; IODINE; MEPHITIS MEPHITIS ANAL GLAND FLUID; SPONGIA OFFICINALIS SKELETON, ROASTED</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for relief of minor cough symptoms from the common cold or inhaled irritants: 1 cough with mucus, 2 dry cough, 3 rapid, barking cough, 4 wheezing cough.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7225-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-7225-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-7225-01</NDC11Code>
<ProductNDC>57955-7225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stye Symptom Formula</ProprietaryName>
<NonProprietaryName>Apis Mellifica, Calcarea Picrata, Graphites, Hepar Sulphuris Calcareum, Juglans Regia, Lycopodium Clavatum, Pulsatilla, Silicea, Staphysagria, Sulfur, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; CALCIUM PICRATE; GRAPHITE; CALCIUM SULFIDE; JUGLANS REGIA WHOLE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief from symptoms of styes or hordeolums: 1 swollen eyelids, 2 eyelid discomfort, 3 redness, 4 sensitivity to touch, 5 inflammation, 6 itching, 7 stinging.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7295-2</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-7295-2) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-7295-02</NDC11Code>
<ProductNDC>57955-7295</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ear Ringing Symptom Formula</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calcarea Carbonica, Chenopodium Anthelminticum, Chininum Salicylicum, Cimicifuga Racemosa, Coffea Tosta, Kali Iodatum, Kalmia Latifolia, Magnesia Carbonica, Manganum Aceticum, Manganum Carbonicum, Mercurius Vivus, Natrum Salicylicum, Salicylicum Acidum, Thiosinaminum, Thyroidinum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131209</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; QUININE SALICYLATE; BLACK COHOSH; COFFEA ARABICA SEED, ROASTED; POTASSIUM IODIDE; KALMIA LATIFOLIA LEAF; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; MANGANESE CARBONATE; MERCURY; SODIUM SALICYLATE; SALICYLIC ACID; ALLYLTHIOUREA; THYROID, UNSPECIFIED</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptomic relief of ear sounds: 1 buzzing, roaring, ringing, and whistling, 2 sensitivity to noise.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-8058-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-8058-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-8058-01</NDC11Code>
<ProductNDC>57955-8058</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gallbladder Symptom Formula</ProprietaryName>
<NonProprietaryName>Berberis Vulgaris, Bryonia Alba, Carduus Marianus, Chelidonium Majus, Cholesterinum, Cinchona Officinalis, Colocynthis, Dioscorea Villosa, Lycopodium Clavatum And Natrum Sulphuricum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of minor gallbladder symptoms: 1 indigestion, 2 bloating, 3 gas, 4 bitter taste in mouth, 5 abdominal discomforts after eating.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-8300-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-8300-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-8300-01</NDC11Code>
<ProductNDC>57955-8300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Food Intolerances</ProprietaryName>
<NonProprietaryName>Aethusa Cynapium, Calcarea Carbonica, Cucurbita Pepo, Semen, Gambogia, Histaminum Hydrochloricum, Hydrastis Canadensis, Lycopodium Clavatum, Natrum Carbonicum, Nitricum Acidum, Nux Vomica, Ovi Gallinae Pellicula, Phosphorus, Pulsatilla, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AETHUSA CYNAPIUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PUMPKIN SEED; GAMBOGE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; EGG SHELL MEMBRANE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms associated with food intolerances and sensitivities: 1 headache, 2 irritability, 3 stomach cramps and indigestion, 4 nausea, 5 gas, heartburn and bloating, 6 constipation, 7 diarrhea, 8 sensitivities to meat, fat, salt, dairy, starches and vegetables.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-8310-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-8310-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-8310-01</NDC11Code>
<ProductNDC>57955-8310</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pet Hair And Dander Allergies</ProprietaryName>
<NonProprietaryName>Aralia Racemosa, Arsenicum Album, Histaminum Hydrochloricum, Nux Vomica, Oleum Animale, Phosphorus, Silicea, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131112</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; HISTAMINE DIHYDROCHLORIDE; STRYCHNOS NUX-VOMICA SEED; CERVUS ELAPHUS HORN OIL; PHOSPHORUS; SILICON DIOXIDE; SULFUR</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of minor allergy symptoms from pet hair, feathers and dander: skin irritations itchy, watery eyes sneezing, runny nose tickling cough hoarseness congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-8315-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-8315-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-8315-01</NDC11Code>
<ProductNDC>57955-8315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Midwest Regional Allergies</ProprietaryName>
<NonProprietaryName>Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium Cepa, Ambrosia Artemisiaefolia, Cichorium Intybus, Conium Maculatum, Cortisone Aceticum, Euphrasia Officinalis, Fagopyrum Esculentum, Galphimia Glauca, Hedera Helix, Histaminum Hydrochloricum, Kali Muriaticum, Mucosa Nasalis Suis, Natrum Muriaticum, Rna, Rumex Crispus, Sabadilla, Secale Cornutum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; AMBROSIA ARTEMISIIFOLIA; CHICORY ROOT; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; CLAVICEPS PURPUREA SCLEROTIUM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of allergy symptoms commonly experienced in IA, IL, IN, KS, MI, MN, MO, ND, NE, OH, SD, WI: 1 itchy, watery eyes, 2 runny nose, 3 sneezing, 4 sore throat, 5 sinus congestion, 6 cough, 7 stuffy nose, 8 fatigue, 9 itchy, irritated skin, 10 hoarseness, 11 headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-8325-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-8325-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-8325-01</NDC11Code>
<ProductNDC>57955-8325</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Northeast Regional Allergies</ProprietaryName>
<NonProprietaryName>Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agraphis Nutans, Allium Cepa, Collinsonia Canadensis, Cortisone Aceticum, Euphrasia Officinalis, Galphimia Glauca, Histaminum Hydrochloricum, Kali Muriaticum, Mucosa Nasalis Suis, Natrum Muriaticum, Rna, Rumex Crispus, Sabadilla, Salvia Officinalis, Tanacetum Vulgare, Trifolium Pratense, Vinca Minor</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; HYACINTHOIDES NON-SCRIPTA; ONION; COLLINSONIA CANADENSIS ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; SAGE; TANACETUM VULGARE TOP; TRIFOLIUM PRATENSE FLOWER; VINCA MINOR</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of allergy symptoms commonly experienced in CT, MA, ME, NH, NJ, NY, PA, RI, VT: 1 itchy, watery eyes, 2 runny nose, 3 sneezing, 4 sore throat , 5 sinus congestion, 6 cough, 7 stuffy nose , 8 fatigue, 9 itchy, irritated skin, 10 hoarseness, 11 headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-8330-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-8330-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-8330-01</NDC11Code>
<ProductNDC>57955-8330</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pacific Regional Allergies</ProprietaryName>
<NonProprietaryName>Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Alfalfa, Allium Cepa, Bellis Perennis, Conium Maculatum, Cortisone Aceticum, Equisetum Hyemale, Euphrasia Officinalis, Fagopyrum Esculentum, Galphimia Glauca, Histaminum Hydrochloricum, Kali Muriaticum, Millefolium, Mucosa Nasalis Suis, Natrum Muriaticum, Prunus Spinosa, Rna, Sabadilla, Solidago Virgaurea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131126</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ALFALFA; ONION; BELLIS PERENNIS; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EQUISETUM HYEMALE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; ACHILLEA MILLEFOLIUM; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PRUNUS SPINOSA FLOWER BUD; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of allergy symptoms commonly experienced in CA, OR, WA: 1 itchy, watery eyes, 2 runny nose, 3 sneezing, 4 sore throat, 5 sinus congestion, 6 cough, 7 stuffy nose, 8 fatigue, 9 itchy, irritated skin, 10 hoarseness, 11 headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-8345-1</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-8345-1) > 29.6 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>57955-8345-01</NDC11Code>
<ProductNDC>57955-8345</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Southeast Regional Allergies</ProprietaryName>
<NonProprietaryName>Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium Cepa, Alnus Serrulata, Carduus Benedictus, Cichorium Intybus, Cortisone Aceticum, Dolichos Pruriens, Euphrasia Officinalis, Galphimia Glauca, Histaminum Hydrochloricum, Juglans Cinerea, Kali Muriaticum, Mucosa Nasalis Suis, Nasturtium Aquaticum, Natrum Muriaticum, Rna, Rhus Toxicodendron, Sabadilla, Sassafras Officinale</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131031</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; ALNUS SERRULATA BARK; CENTAUREA BENEDICTA; CHICORY ROOT; CORTISONE ACETATE; MUCUNA PRURIENS FRUIT TRICHOME; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; NASTURTIUM OFFICINALE; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SASSAFRAS ALBIDUM ROOT BARK</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of allergy symptoms commonly experienced in AL, AR, DC, DE, FL, GA, KY, LA, MD, MS, NC, SC, TN, VA, WV: 1 itchy, watery eyes, 2 runny nose, 3 sneezing, 4 sore throat, 5 sinus congestion, 6 cough, 7 stuffy nose, 8 fatigue, 9 itchy, irritated skin, 10 hoarseness, 11 headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>22840-1602-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-1602-2) </PackageDescription>
<NDC11Code>22840-1602-02</NDC11Code>
<ProductNDC>22840-1602</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Alternaria Alternata</ProprietaryName>
<NonProprietaryName>Alternaria Alternata</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/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>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen.</Description>
</NDC>
<NDC>
<NDCCode>22840-1602-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-1602-4) </PackageDescription>
<NDC11Code>22840-1602-04</NDC11Code>
<ProductNDC>22840-1602</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Alternaria Alternata</ProprietaryName>
<NonProprietaryName>Alternaria Alternata</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/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>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen.</Description>
</NDC>
<NDC>
<NDCCode>41167-1602-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41167-1602-2) / 85 g in 1 BOTTLE</PackageDescription>
<NDC11Code>41167-1602-02</NDC11Code>
<ProductNDC>41167-1602</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flexall Pain Relieving</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19970101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Chattem, Inc.</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>.16</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor pain associated with: 1 arthritis, 2 simple backache, 3 muscle strains, 4 sprains , 5 bruises, 6 cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-1602-0</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (50090-1602-0) </PackageDescription>
<NDC11Code>50090-1602-00</NDC11Code>
<ProductNDC>50090-1602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefaclor</ProprietaryName>
<NonProprietaryName>Cefaclor</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065146</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CEFACLOR</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsule and other antibacterial drugs, Cefaclor Capsule 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 of therapy.</IndicationAndUsage>
<Description>Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN3O4SH2O and the molecular weight is 385.82. Each 250-mg capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) of anhydrous cefaclor and inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc. The 250 mg capsule shell contains gelatin, titanium dioxide, FD & C Blue No. 1, FD & C Red No. 3, and imprinting ink components: shellac, strong ammonia solution, potassium hydroxide, black iron oxide, .dehydrated alcohol, isopropyl alcohol, butyl alcohol and propylene glycol. Each 500-mg capsule contains cefaclor monohydrate equivalent to 500 mg (1.36 mmol) of anhydrous cefaclor and inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc. The 500 mg capsule shell contains gelatin, titanium dioxide, FD & C Blue No. 1, FD & C Red No. 3, FD & C Yellow No. 6, FD & C Red No. 40, and imprinting ink components: shellac, strong ammonia solution, titanium dioxide, FD & C Blue No. 1 aluminum lake, dehydrated alcohol, isopropyl alcohol, butyl alcohol and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>50090-1602-2</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (50090-1602-2) </PackageDescription>
<NDC11Code>50090-1602-02</NDC11Code>
<ProductNDC>50090-1602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefaclor</ProprietaryName>
<NonProprietaryName>Cefaclor</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065146</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CEFACLOR</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsule and other antibacterial drugs, Cefaclor Capsule 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 of therapy.</IndicationAndUsage>
<Description>Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN3O4SH2O and the molecular weight is 385.82. Each 250-mg capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) of anhydrous cefaclor and inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc. The 250 mg capsule shell contains gelatin, titanium dioxide, FD & C Blue No. 1, FD & C Red No. 3, and imprinting ink components: shellac, strong ammonia solution, potassium hydroxide, black iron oxide, .dehydrated alcohol, isopropyl alcohol, butyl alcohol and propylene glycol. Each 500-mg capsule contains cefaclor monohydrate equivalent to 500 mg (1.36 mmol) of anhydrous cefaclor and inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc. The 500 mg capsule shell contains gelatin, titanium dioxide, FD & C Blue No. 1, FD & C Red No. 3, FD & C Yellow No. 6, FD & C Red No. 40, and imprinting ink components: shellac, strong ammonia solution, titanium dioxide, FD & C Blue No. 1 aluminum lake, dehydrated alcohol, isopropyl alcohol, butyl alcohol and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>59469-313-10</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-313-10) > 50 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0313-10</NDC11Code>
<ProductNDC>59469-313</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Opsonat</ProprietaryName>
<NonProprietaryName>Silver Nitrate, Sulfuric Acid, Bellis Perennis, Lytta Vesicatoria, Gratiola Officinalis, Goldenseal, Lachesis Muta Venom, And Glechoma Hederacea Flowering Top</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190624</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>SILVER NITRATE; SULFURIC ACID; BELLIS PERENNIS WHOLE; LYTTA VESICATORIA; GRATIOLA OFFICINALIS WHOLE; GOLDENSEAL; LACHESIS MUTA VENOM; GLECHOMA HEDERACEA FLOWERING TOP</SubstanceName>
<StrengthNumber>6; 6; 1; 4; 4; 5; 8; 1602</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of minor mucous membrane inflammation, such as the mouth. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59469-313-40</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-313-40) > 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0313-40</NDC11Code>
<ProductNDC>59469-313</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Opsonat</ProprietaryName>
<NonProprietaryName>Silver Nitrate, Sulfuric Acid, Bellis Perennis, Lytta Vesicatoria, Gratiola Officinalis, Goldenseal, Lachesis Muta Venom, And Glechoma Hederacea Flowering Top</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190624</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>SILVER NITRATE; SULFURIC ACID; BELLIS PERENNIS WHOLE; LYTTA VESICATORIA; GRATIOLA OFFICINALIS WHOLE; GOLDENSEAL; LACHESIS MUTA VENOM; GLECHOMA HEDERACEA FLOWERING TOP</SubstanceName>
<StrengthNumber>6; 6; 1; 4; 4; 5; 8; 1602</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of minor mucous membrane inflammation, such as the mouth. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60681-1602-1</NDCCode>
<PackageDescription>1 DOSE PACK in 1 CARTON (60681-1602-1) > 10 SUPPOSITORY in 1 DOSE PACK</PackageDescription>
<NDC11Code>60681-1602-01</NDC11Code>
<ProductNDC>60681-1602</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pleo Leptu</ProprietaryName>
<NonProprietaryName>Propionibacterium Avidum</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>19960319</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sanum Kehlbeck GmbH & Co. KG</LabelerName>
<SubstanceName>PROPIONIBACTERIUM AVIDUM</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[HP_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For temporary relief of cramped or aching muscles.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67046-1602-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-1602-3) </PackageDescription>
<NDC11Code>67046-1602-03</NDC11Code>
<ProductNDC>67046-1602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abacavir</ProprietaryName>
<NonProprietaryName>Abacavir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091560</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>ABACAVIR SULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A1 Inhibitors [MoA], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.</IndicationAndUsage>
<Description>Abacavir sulfate, USP is a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate, USP is (1S,4R)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate, USP is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2H2SO4 and a molecular weight of 670.74 daltons. It has the following structural formula. Abacavir sulfate, USP is a white to off-white powder. Soluble in water, slightly soluble in methanol. It has an octanol per water (pH 3.3) partition coefficient (log P) of approximately 1 by UV-spectrometry at 25°C. Abacavir tablets, USP are for oral administration. Each tablet contains abacavir sulfate, USP equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The tablets are coated with opadry yellow which contains hypromellose, titanium dioxide, triacetin, iron oxide yellow, polysorbate 80. In vivo,abacavir sulfate, USP dissociates to its free base, abacavir. All dosages for abacavir sulfate, USP are expressed in terms of abacavir.</Description>
</NDC>
</NDCList>