{
"NDC": [
{
"NDCCode": "68428-748-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-748-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-748-14)",
"NDC11Code": "68428-0748-29",
"ProductNDC": "68428-748",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Painful Urination",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Berberis Vulgaris Root Bark - Turpentine Oil - Lycopodium Clavatum Spore",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK; TURPENTINE OIL; LYCOPODIUM CLAVATUM SPORE",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications:. BERBER VULG Burning pains. TEREBINTHINA Frequent urging. LYCOPODIUM Hot urine."
},
{
"NDCCode": "68428-718-29",
"PackageDescription": "56 g in 1 TUBE (68428-718-29) ",
"NDC11Code": "68428-0718-29",
"ProductNDC": "68428-718",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Bruises And Bumps",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/56g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130315",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. ARNICA Bruising."
},
{
"NDCCode": "68428-719-29",
"PackageDescription": "56 g in 1 TUBE (68428-719-29) ",
"NDC11Code": "68428-0719-29",
"ProductNDC": "68428-719",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Cuts And Scrapes",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Calendula Officinalis Flowering Top",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/56g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130315",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. CALENDULA Promotes healing."
},
{
"NDCCode": "68428-720-29",
"PackageDescription": "56 g in 1 TUBE (68428-720-29) ",
"NDC11Code": "68428-0720-29",
"ProductNDC": "68428-720",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Minor Arthritic Pain",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Arnica Montana - Rhus Toxicodendron - Ruta Graveolens",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARNICA MONTANA; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "3; 3; 3",
"StrengthUnit": "[hp_X]/56g; [hp_X]/56g; [hp_X]/56g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130315",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. ARNICA MONTANA Bruises. RHUS TOXICODENDRON Better motion. RUTA GRAVEOLENS Bruised feeling."
},
{
"NDCCode": "68428-721-29",
"PackageDescription": "56 g in 1 TUBE (68428-721-29) ",
"NDC11Code": "68428-0721-29",
"ProductNDC": "68428-721",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Scars",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Thiosinaminum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ALLYLTHIOUREA",
"StrengthNumber": "2",
"StrengthUnit": "[hp_X]/56g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130315",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. THIOSINAMINUM Scarring."
},
{
"NDCCode": "68428-722-29",
"PackageDescription": "56 g in 1 TUBE (68428-722-29) ",
"NDC11Code": "68428-0722-29",
"ProductNDC": "68428-722",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Warts And Tired Feet",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130315",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/56g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130315",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. THUJA OCCIDENTALIS Warts."
},
{
"NDCCode": "68428-725-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-725-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-725-14) ",
"NDC11Code": "68428-0725-29",
"ProductNDC": "68428-725",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Poison Ivy",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Toxicodendron Pubescens Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130228",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160419",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. RHUS TOX Better motion."
},
{
"NDCCode": "68428-726-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-726-29) > 28 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "68428-0726-29",
"ProductNDC": "68428-726",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Insomnia",
"NonProprietaryName": "Matricaria Recutita - Arabica Coffee Bean - Hyoscyamus Niger - Strychnos Ignatii Seed - Strychnos Nux-vomica Seed -passiflora Incarnata Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARABICA COFFEE BEAN; HYOSCYAMUS NIGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130301",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. CHAMOMILLA Irritability. COFFEA CRUDA Sleeplessness. HYOSCYAMUS Twitching. IGNATIA Sadness. NUX VOMICA Vomiting. PASSIFLORA Insomnia."
},
{
"NDCCode": "68428-728-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-728-29) > 28 g in 1 BOTTLE, PLASTIC (68428-728-14) ",
"NDC11Code": "68428-0728-29",
"ProductNDC": "68428-728",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Minor Arthritic Pain",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Apis Mellifera, Black Cohosh, Calcium Fluoride, Sodium Phosphate, Dibasic, Heptahydrate, Toxicodendron Pubescens Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130228",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "APIS MELLIFERA; BLACK COHOSH; CALCIUM FLUORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130228",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. APIS MEL Stiffness. CALC FLUOR Enlargement of joints. CIMICIFUGA Aching. NAT PHOS Pain in knees. RHUS TOX Minor arthritic pain."
},
{
"NDCCode": "68428-730-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-730-29) > 28 g in 1 BOTTLE, PLASTIC (68428-730-14) ",
"NDC11Code": "68428-0730-29",
"ProductNDC": "68428-730",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Sinus Congestion",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Oyster Shell Calcium Carbonate, Crude - Goldenseal - Potassium Dichromate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130228",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130228",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. CALC CARB - OVERWORK. HYDRASTIS - SINUSES. KALI BIC - SINUSES."
},
{
"NDCCode": "68428-731-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-731-29) > 28 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "68428-0731-29",
"ProductNDC": "68428-731",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Be Gone Smoking",
"NonProprietaryName": "Dieffenbachia Seguine - Daphne Odora Bark - Strychnos Nux-vomica Seed - Plantago Major - Delphinium Staphisagria Seed - Tobacco Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; PLANTAGO MAJOR; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF",
"StrengthNumber": "6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130301",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. CALADIUM Motion sickness. DAPHNE Bad breath. NUX VOM Vomiting. PLANTAGO Earache. STAPHYSAG Anger. TABACUM Sea sickness."
},
{
"NDCCode": "68428-745-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-745-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-745-14)",
"NDC11Code": "68428-0745-29",
"ProductNDC": "68428-745",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Diarrhea",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Arsenic Trioxide - Cupric Arsenite - Veratrum Album Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARSENIC TRIOXIDE; CUPRIC ARSENITE; VERATRUM ALBUM ROOT",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications:. Arsenicum alb 6c –small, offensive stool*. Cuprum ars 6c –watery stool*. Veratrum alb 6c –large stool*. ■ Cramps* ■ Vomiting* ■ Spasmodic pains*. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "68428-746-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (68428-746-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-746-14)",
"NDC11Code": "68428-0746-29",
"ProductNDC": "68428-746",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Flatulence",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Ferula Assa-foetida Resin, Strychnos Ignatii Seed, Nutmeg",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FERULA ASSA-FOETIDA RESIN; NUTMEG; STRYCHNOS IGNATII SEED",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. Asafoetida 6c –offensive odor*. Ignatia 6c –much flatulence*. Nux mosch 6c –indigestion/bloating*. ■ Bloating* ■ Gas* ■ Sour stomach* ■ Heartburn*. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "68428-747-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-747-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-747-14)",
"NDC11Code": "68428-0747-29",
"ProductNDC": "68428-747",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Congested Headache",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Calcium Fluoride - Ferrosoferric Phosphate - Sodium Phosphate, Dibasic, Heptahydrate - Sodium Chloride",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. Calc fluor 6c –cracking noise*. Ferrum phos 6c –worse motion*. Nat phos 6c –throbbing headache*. Nat mur 6c –blinding headache*. ■ Weakness* ■ Dizziness* ■ Stress-related*. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "68428-749-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (68428-749-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-749-14)",
"NDC11Code": "68428-0749-29",
"ProductNDC": "68428-749",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Skin Irritation",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Arsenic Trioxide - Calcium Sulfate Anhydrous - Sodium Phosphate, Dibasic, Heptahydrate - Silicon Dioxide",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications:. ARSENICUM ALB Scaley, red, dry. CALC SULPH Slow healing. NAT PHOS Smooth, red, shining. SILICEA Boils, waxy, painful scars."
},
{
"NDCCode": "68428-862-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (68428-862-29) > 12000 PELLET in 1 BOTTLE, PLASTIC (68428-862-14)",
"NDC11Code": "68428-0862-29",
"ProductNDC": "68428-862",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Teething",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Tribasic Calcium Phosphate - Matricaria Chamomilla - Arabica Coffee Bean",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARABICA COFFEE BEAN; MATRICARIA CHAMOMILLA; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications:. Calc phos 6c –troubled teething*. Chamomilla 6c –distressed teething*. Coffea cruda 6c –sensitive teething*. ■ Irritability ■ Restlessness ■ Sleeplessness. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "68428-997-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (68428-997-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-997-14)",
"NDC11Code": "68428-0997-29",
"ProductNDC": "68428-997",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Hangover",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Activated Charcoal, Arabica Coffee Bean, Ipecac, Strychnos Nux-vomica Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160513",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ACTIVATED CHARCOAL; ARABICA COFFEE BEAN; IPECAC; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. Carbo veg 6c –effects of alcohol*. Coffea cruda 6c –headache*. Ipecac 6c –nausea*. Nux vom 6c –over-indulgence*. ■ Nausea* ■ Loss of appetite* ■ Headache*. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "68428-998-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (68428-998-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-998-14)",
"NDC11Code": "68428-0998-29",
"ProductNDC": "68428-998",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Stings",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Apis Mellifera, Arabica Coffee Bean, Ipecac, Strychnos Nux-vomica Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160513",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "APIS MELLIFERA; HYPERICUM PERFORATUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; URTICA URENS",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. Apis mel 30c –stinging pains*. Hypericum 30c –insect bites*. Ledum 30c –insect bites*. Urtica ur 30c –bee stings*. ■ Insect bites ■ Bee stings ■ Mosquito bites. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "68428-999-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 PACKAGE (68428-999-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-999-14)",
"NDC11Code": "68428-0999-29",
"ProductNDC": "68428-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whp Be Gone Stress",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Helianthemum Nummularium Flower, Impatiens Glandulifera Flower, Olea Europaea Flower, Ornithogalum Umbellatum Flowering Top, Prunus Cerasifera Flower",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160513",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER",
"StrengthNumber": "5; 5; 5; 5; 5",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications. Helianthemum num, flos 5x (Rock Rose) –acute anxiety*. Impatiens glan, flos 5x (Impatiens) –impatience*. Olea eur, flos 5x (Olive) –mental fatigue*. Ornithogalum umbellatum, flos 5x (Star of Bethlehem) –after effects of shock*. Prunus cera, flos 5x (Cherry Plum) –desperation. ■ Fear and worrying ■ Impatience ■ Feeling overwhelmed ■ Stage fright. *These statements have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "67877-748-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (67877-748-01) ",
"NDC11Code": "67877-0748-01",
"ProductNDC": "67877-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214753",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210313",
"SamplePackage": "N",
"IndicationAndUsage": " Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1). o Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). Sirolimus tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Sirolimus tablets are also available as a tan, round-shaped tablet containing 0.5 mg sirolimus, as a white, round-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige round-shaped tablet containing 2 mg sirolimus. The inactive ingredients in sirolimus tablets include edetate disodium, poloxamer 188, sucrose, Hypromellose, vitamin E, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, glyceryl behenate.The 0.5 mg strength also contains polyethylene glycol and the 1 mg and the 2 mg contains polyvinyl alcohol, talc, titanium dioxide, sodium lauryl sulphate, glyceryl monocaprylocaprate, yellow iron oxide, black iron oxide, red iron oxide. Also 2 mg additionally contains FD & C Yellow # 6 and lake pigment D & C Yellow # 10."
},
{
"NDCCode": "67877-748-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (67877-748-05) ",
"NDC11Code": "67877-0748-05",
"ProductNDC": "67877-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214753",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210313",
"SamplePackage": "N",
"IndicationAndUsage": " Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1). o Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). Sirolimus tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Sirolimus tablets are also available as a tan, round-shaped tablet containing 0.5 mg sirolimus, as a white, round-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige round-shaped tablet containing 2 mg sirolimus. The inactive ingredients in sirolimus tablets include edetate disodium, poloxamer 188, sucrose, Hypromellose, vitamin E, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, glyceryl behenate.The 0.5 mg strength also contains polyethylene glycol and the 1 mg and the 2 mg contains polyvinyl alcohol, talc, titanium dioxide, sodium lauryl sulphate, glyceryl monocaprylocaprate, yellow iron oxide, black iron oxide, red iron oxide. Also 2 mg additionally contains FD & C Yellow # 6 and lake pigment D & C Yellow # 10."
},
{
"NDCCode": "67877-748-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (67877-748-30) ",
"NDC11Code": "67877-0748-30",
"ProductNDC": "67877-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214753",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210313",
"SamplePackage": "N",
"IndicationAndUsage": " Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1). o Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). Sirolimus tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Sirolimus tablets are also available as a tan, round-shaped tablet containing 0.5 mg sirolimus, as a white, round-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige round-shaped tablet containing 2 mg sirolimus. The inactive ingredients in sirolimus tablets include edetate disodium, poloxamer 188, sucrose, Hypromellose, vitamin E, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, glyceryl behenate.The 0.5 mg strength also contains polyethylene glycol and the 1 mg and the 2 mg contains polyvinyl alcohol, talc, titanium dioxide, sodium lauryl sulphate, glyceryl monocaprylocaprate, yellow iron oxide, black iron oxide, red iron oxide. Also 2 mg additionally contains FD & C Yellow # 6 and lake pigment D & C Yellow # 10."
},
{
"NDCCode": "67877-748-38",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (67877-748-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-748-33) ",
"NDC11Code": "67877-0748-38",
"ProductNDC": "67877-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214753",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210313",
"SamplePackage": "N",
"IndicationAndUsage": " Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1). o Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). Sirolimus tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Sirolimus tablets are also available as a tan, round-shaped tablet containing 0.5 mg sirolimus, as a white, round-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige round-shaped tablet containing 2 mg sirolimus. The inactive ingredients in sirolimus tablets include edetate disodium, poloxamer 188, sucrose, Hypromellose, vitamin E, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, glyceryl behenate.The 0.5 mg strength also contains polyethylene glycol and the 1 mg and the 2 mg contains polyvinyl alcohol, talc, titanium dioxide, sodium lauryl sulphate, glyceryl monocaprylocaprate, yellow iron oxide, black iron oxide, red iron oxide. Also 2 mg additionally contains FD & C Yellow # 6 and lake pigment D & C Yellow # 10."
},
{
"NDCCode": "71205-748-07",
"PackageDescription": "7 CAPSULE in 1 BOTTLE (71205-748-07) ",
"NDC11Code": "71205-0748-07",
"ProductNDC": "71205-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078938",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230119",
"SamplePackage": "N",
"IndicationAndUsage": "Tamsulosin hydrochloride is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1).",
"Description": "Tamsulosin hydrochloride, USP is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride, USP is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white to almost white powder that melts at approximately 227° to 228°C. It is slightly soluble in water, freely soluble in formic acid. The molecular formula of tamsulosin hydrochloride is C20H28N2O5SHCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule, USP* for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer dispersion, talc, triethyl citrate, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No 10, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. * Meets USP Dissolution Test 6."
},
{
"NDCCode": "71205-748-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (71205-748-14) ",
"NDC11Code": "71205-0748-14",
"ProductNDC": "71205-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078938",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230119",
"SamplePackage": "N",
"IndicationAndUsage": "Tamsulosin hydrochloride is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1).",
"Description": "Tamsulosin hydrochloride, USP is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride, USP is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white to almost white powder that melts at approximately 227° to 228°C. It is slightly soluble in water, freely soluble in formic acid. The molecular formula of tamsulosin hydrochloride is C20H28N2O5SHCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule, USP* for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer dispersion, talc, triethyl citrate, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No 10, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. * Meets USP Dissolution Test 6."
},
{
"NDCCode": "71205-748-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (71205-748-30) ",
"NDC11Code": "71205-0748-30",
"ProductNDC": "71205-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078938",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230119",
"SamplePackage": "N",
"IndicationAndUsage": "Tamsulosin hydrochloride is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1).",
"Description": "Tamsulosin hydrochloride, USP is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride, USP is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white to almost white powder that melts at approximately 227° to 228°C. It is slightly soluble in water, freely soluble in formic acid. The molecular formula of tamsulosin hydrochloride is C20H28N2O5SHCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule, USP* for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer dispersion, talc, triethyl citrate, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No 10, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. * Meets USP Dissolution Test 6."
},
{
"NDCCode": "71205-748-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71205-748-60) ",
"NDC11Code": "71205-0748-60",
"ProductNDC": "71205-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078938",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230119",
"SamplePackage": "N",
"IndicationAndUsage": "Tamsulosin hydrochloride is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1).",
"Description": "Tamsulosin hydrochloride, USP is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride, USP is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white to almost white powder that melts at approximately 227° to 228°C. It is slightly soluble in water, freely soluble in formic acid. The molecular formula of tamsulosin hydrochloride is C20H28N2O5SHCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule, USP* for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer dispersion, talc, triethyl citrate, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No 10, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. * Meets USP Dissolution Test 6."
},
{
"NDCCode": "71205-748-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71205-748-90) ",
"NDC11Code": "71205-0748-90",
"ProductNDC": "71205-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078938",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230119",
"SamplePackage": "N",
"IndicationAndUsage": "Tamsulosin hydrochloride is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1).",
"Description": "Tamsulosin hydrochloride, USP is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride, USP is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white to almost white powder that melts at approximately 227° to 228°C. It is slightly soluble in water, freely soluble in formic acid. The molecular formula of tamsulosin hydrochloride is C20H28N2O5SHCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule, USP* for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer dispersion, talc, triethyl citrate, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No 10, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. * Meets USP Dissolution Test 6."
},
{
"NDCCode": "68428-018-14",
"PackageDescription": "28 g in 1 BOTTLE, PLASTIC (68428-018-14) ",
"NDC11Code": "68428-0018-14",
"ProductNDC": "68428-018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colds And Cough",
"NonProprietaryName": "Aconitum Napellus - Bryonia Alba Root - Sanguinaria Canadensis Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100402",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ACONITUM NAPELLUS; BRYONIA ALBA ROOT; SANGUINARIA CANADENSIS ROOT",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Status": "Deprecated",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100402",
"SamplePackage": "N"
},
{
"NDCCode": "68428-332-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-332-05) ",
"NDC11Code": "68428-0332-05",
"ProductNDC": "68428-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coffea Tosta",
"NonProprietaryName": "Coffea Arabica Seed, Roasted",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "COFFEA ARABICA SEED, ROASTED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68428-748-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-748-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-748-14)</PackageDescription>
<NDC11Code>68428-0748-29</NDC11Code>
<ProductNDC>68428-748</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Painful Urination</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Berberis Vulgaris Root Bark - Turpentine Oil - Lycopodium Clavatum Spore</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK; TURPENTINE OIL; LYCOPODIUM CLAVATUM SPORE</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications:. BERBER VULG Burning pains. TEREBINTHINA Frequent urging. LYCOPODIUM Hot urine.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-718-29</NDCCode>
<PackageDescription>56 g in 1 TUBE (68428-718-29) </PackageDescription>
<NDC11Code>68428-0718-29</NDC11Code>
<ProductNDC>68428-718</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Bruises And Bumps</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Arnica Montana</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/56g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. ARNICA Bruising.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-719-29</NDCCode>
<PackageDescription>56 g in 1 TUBE (68428-719-29) </PackageDescription>
<NDC11Code>68428-0719-29</NDC11Code>
<ProductNDC>68428-719</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Cuts And Scrapes</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Calendula Officinalis Flowering Top</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/56g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. CALENDULA Promotes healing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-720-29</NDCCode>
<PackageDescription>56 g in 1 TUBE (68428-720-29) </PackageDescription>
<NDC11Code>68428-0720-29</NDC11Code>
<ProductNDC>68428-720</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Minor Arthritic Pain</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Arnica Montana - Rhus Toxicodendron - Ruta Graveolens</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARNICA MONTANA; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/56g; [hp_X]/56g; [hp_X]/56g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. ARNICA MONTANA Bruises. RHUS TOXICODENDRON Better motion. RUTA GRAVEOLENS Bruised feeling.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-721-29</NDCCode>
<PackageDescription>56 g in 1 TUBE (68428-721-29) </PackageDescription>
<NDC11Code>68428-0721-29</NDC11Code>
<ProductNDC>68428-721</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Scars</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Thiosinaminum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ALLYLTHIOUREA</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>[hp_X]/56g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. THIOSINAMINUM Scarring.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-722-29</NDCCode>
<PackageDescription>56 g in 1 TUBE (68428-722-29) </PackageDescription>
<NDC11Code>68428-0722-29</NDC11Code>
<ProductNDC>68428-722</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Warts And Tired Feet</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/56g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. THUJA OCCIDENTALIS Warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-725-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-725-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-725-14) </PackageDescription>
<NDC11Code>68428-0725-29</NDC11Code>
<ProductNDC>68428-725</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Poison Ivy</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Toxicodendron Pubescens Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130228</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. RHUS TOX Better motion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-726-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-726-29) > 28 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>68428-0726-29</NDC11Code>
<ProductNDC>68428-726</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Insomnia</ProprietaryName>
<NonProprietaryName>Matricaria Recutita - Arabica Coffee Bean - Hyoscyamus Niger - Strychnos Ignatii Seed - Strychnos Nux-vomica Seed -passiflora Incarnata Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN; HYOSCYAMUS NIGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. CHAMOMILLA Irritability. COFFEA CRUDA Sleeplessness. HYOSCYAMUS Twitching. IGNATIA Sadness. NUX VOMICA Vomiting. PASSIFLORA Insomnia.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-728-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-728-29) > 28 g in 1 BOTTLE, PLASTIC (68428-728-14) </PackageDescription>
<NDC11Code>68428-0728-29</NDC11Code>
<ProductNDC>68428-728</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Minor Arthritic Pain</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Apis Mellifera, Black Cohosh, Calcium Fluoride, Sodium Phosphate, Dibasic, Heptahydrate, Toxicodendron Pubescens Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130228</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>APIS MELLIFERA; BLACK COHOSH; CALCIUM FLUORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. APIS MEL Stiffness. CALC FLUOR Enlargement of joints. CIMICIFUGA Aching. NAT PHOS Pain in knees. RHUS TOX Minor arthritic pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-730-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-730-29) > 28 g in 1 BOTTLE, PLASTIC (68428-730-14) </PackageDescription>
<NDC11Code>68428-0730-29</NDC11Code>
<ProductNDC>68428-730</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Sinus Congestion</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Oyster Shell Calcium Carbonate, Crude - Goldenseal - Potassium Dichromate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130228</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. CALC CARB - OVERWORK. HYDRASTIS - SINUSES. KALI BIC - SINUSES.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-731-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-731-29) > 28 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>68428-0731-29</NDC11Code>
<ProductNDC>68428-731</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Be Gone Smoking</ProprietaryName>
<NonProprietaryName>Dieffenbachia Seguine - Daphne Odora Bark - Strychnos Nux-vomica Seed - Plantago Major - Delphinium Staphisagria Seed - Tobacco Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; PLANTAGO MAJOR; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. CALADIUM Motion sickness. DAPHNE Bad breath. NUX VOM Vomiting. PLANTAGO Earache. STAPHYSAG Anger. TABACUM Sea sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-745-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-745-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-745-14)</PackageDescription>
<NDC11Code>68428-0745-29</NDC11Code>
<ProductNDC>68428-745</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Diarrhea</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Arsenic Trioxide - Cupric Arsenite - Veratrum Album Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; CUPRIC ARSENITE; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications:. Arsenicum alb 6c –small, offensive stool*. Cuprum ars 6c –watery stool*. Veratrum alb 6c –large stool*. ■ Cramps* ■ Vomiting* ■ Spasmodic pains*. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-746-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (68428-746-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-746-14)</PackageDescription>
<NDC11Code>68428-0746-29</NDC11Code>
<ProductNDC>68428-746</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Flatulence</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Ferula Assa-foetida Resin, Strychnos Ignatii Seed, Nutmeg</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FERULA ASSA-FOETIDA RESIN; NUTMEG; STRYCHNOS IGNATII SEED</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. Asafoetida 6c –offensive odor*. Ignatia 6c –much flatulence*. Nux mosch 6c –indigestion/bloating*. ■ Bloating* ■ Gas* ■ Sour stomach* ■ Heartburn*. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-747-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-747-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-747-14)</PackageDescription>
<NDC11Code>68428-0747-29</NDC11Code>
<ProductNDC>68428-747</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Congested Headache</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Fluoride - Ferrosoferric Phosphate - Sodium Phosphate, Dibasic, Heptahydrate - Sodium Chloride</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. Calc fluor 6c –cracking noise*. Ferrum phos 6c –worse motion*. Nat phos 6c –throbbing headache*. Nat mur 6c –blinding headache*. ■ Weakness* ■ Dizziness* ■ Stress-related*. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-749-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (68428-749-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-749-14)</PackageDescription>
<NDC11Code>68428-0749-29</NDC11Code>
<ProductNDC>68428-749</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Skin Irritation</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Arsenic Trioxide - Calcium Sulfate Anhydrous - Sodium Phosphate, Dibasic, Heptahydrate - Silicon Dioxide</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications:. ARSENICUM ALB Scaley, red, dry. CALC SULPH Slow healing. NAT PHOS Smooth, red, shining. SILICEA Boils, waxy, painful scars.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-862-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (68428-862-29) > 12000 PELLET in 1 BOTTLE, PLASTIC (68428-862-14)</PackageDescription>
<NDC11Code>68428-0862-29</NDC11Code>
<ProductNDC>68428-862</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Teething</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Tribasic Calcium Phosphate - Matricaria Chamomilla - Arabica Coffee Bean</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN; MATRICARIA CHAMOMILLA; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications:. Calc phos 6c –troubled teething*. Chamomilla 6c –distressed teething*. Coffea cruda 6c –sensitive teething*. ■ Irritability ■ Restlessness ■ Sleeplessness. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-997-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (68428-997-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-997-14)</PackageDescription>
<NDC11Code>68428-0997-29</NDC11Code>
<ProductNDC>68428-997</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Hangover</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Activated Charcoal, Arabica Coffee Bean, Ipecac, Strychnos Nux-vomica Seed</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160513</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; ARABICA COFFEE BEAN; IPECAC; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. Carbo veg 6c –effects of alcohol*. Coffea cruda 6c –headache*. Ipecac 6c –nausea*. Nux vom 6c –over-indulgence*. ■ Nausea* ■ Loss of appetite* ■ Headache*. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-998-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (68428-998-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-998-14)</PackageDescription>
<NDC11Code>68428-0998-29</NDC11Code>
<ProductNDC>68428-998</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Stings</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Apis Mellifera, Arabica Coffee Bean, Ipecac, Strychnos Nux-vomica Seed</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160513</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>APIS MELLIFERA; HYPERICUM PERFORATUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; URTICA URENS</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. Apis mel 30c –stinging pains*. Hypericum 30c –insect bites*. Ledum 30c –insect bites*. Urtica ur 30c –bee stings*. ■ Insect bites ■ Bee stings ■ Mosquito bites. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-999-29</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (68428-999-29) > 300 PELLET in 1 BOTTLE, PLASTIC (68428-999-14)</PackageDescription>
<NDC11Code>68428-0999-29</NDC11Code>
<ProductNDC>68428-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whp Be Gone Stress</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Helianthemum Nummularium Flower, Impatiens Glandulifera Flower, Olea Europaea Flower, Ornithogalum Umbellatum Flowering Top, Prunus Cerasifera Flower</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160513</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER</SubstanceName>
<StrengthNumber>5; 5; 5; 5; 5</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. Helianthemum num, flos 5x (Rock Rose) –acute anxiety*. Impatiens glan, flos 5x (Impatiens) –impatience*. Olea eur, flos 5x (Olive) –mental fatigue*. Ornithogalum umbellatum, flos 5x (Star of Bethlehem) –after effects of shock*. Prunus cera, flos 5x (Cherry Plum) –desperation. ■ Fear and worrying ■ Impatience ■ Feeling overwhelmed ■ Stage fright. *These statements have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67877-748-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (67877-748-01) </PackageDescription>
<NDC11Code>67877-0748-01</NDC11Code>
<ProductNDC>67877-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sirolimus</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214753</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1). o Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). Sirolimus tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Sirolimus tablets are also available as a tan, round-shaped tablet containing 0.5 mg sirolimus, as a white, round-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige round-shaped tablet containing 2 mg sirolimus. The inactive ingredients in sirolimus tablets include edetate disodium, poloxamer 188, sucrose, Hypromellose, vitamin E, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, glyceryl behenate.The 0.5 mg strength also contains polyethylene glycol and the 1 mg and the 2 mg contains polyvinyl alcohol, talc, titanium dioxide, sodium lauryl sulphate, glyceryl monocaprylocaprate, yellow iron oxide, black iron oxide, red iron oxide. Also 2 mg additionally contains FD & C Yellow # 6 and lake pigment D & C Yellow # 10.</Description>
</NDC>
<NDC>
<NDCCode>67877-748-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (67877-748-05) </PackageDescription>
<NDC11Code>67877-0748-05</NDC11Code>
<ProductNDC>67877-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sirolimus</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214753</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1). o Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). Sirolimus tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Sirolimus tablets are also available as a tan, round-shaped tablet containing 0.5 mg sirolimus, as a white, round-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige round-shaped tablet containing 2 mg sirolimus. The inactive ingredients in sirolimus tablets include edetate disodium, poloxamer 188, sucrose, Hypromellose, vitamin E, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, glyceryl behenate.The 0.5 mg strength also contains polyethylene glycol and the 1 mg and the 2 mg contains polyvinyl alcohol, talc, titanium dioxide, sodium lauryl sulphate, glyceryl monocaprylocaprate, yellow iron oxide, black iron oxide, red iron oxide. Also 2 mg additionally contains FD & C Yellow # 6 and lake pigment D & C Yellow # 10.</Description>
</NDC>
<NDC>
<NDCCode>67877-748-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (67877-748-30) </PackageDescription>
<NDC11Code>67877-0748-30</NDC11Code>
<ProductNDC>67877-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sirolimus</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214753</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1). o Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). Sirolimus tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Sirolimus tablets are also available as a tan, round-shaped tablet containing 0.5 mg sirolimus, as a white, round-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige round-shaped tablet containing 2 mg sirolimus. The inactive ingredients in sirolimus tablets include edetate disodium, poloxamer 188, sucrose, Hypromellose, vitamin E, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, glyceryl behenate.The 0.5 mg strength also contains polyethylene glycol and the 1 mg and the 2 mg contains polyvinyl alcohol, talc, titanium dioxide, sodium lauryl sulphate, glyceryl monocaprylocaprate, yellow iron oxide, black iron oxide, red iron oxide. Also 2 mg additionally contains FD & C Yellow # 6 and lake pigment D & C Yellow # 10.</Description>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1). o Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). Sirolimus tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Sirolimus tablets are also available as a tan, round-shaped tablet containing 0.5 mg sirolimus, as a white, round-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige round-shaped tablet containing 2 mg sirolimus. The inactive ingredients in sirolimus tablets include edetate disodium, poloxamer 188, sucrose, Hypromellose, vitamin E, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, glyceryl behenate.The 0.5 mg strength also contains polyethylene glycol and the 1 mg and the 2 mg contains polyvinyl alcohol, talc, titanium dioxide, sodium lauryl sulphate, glyceryl monocaprylocaprate, yellow iron oxide, black iron oxide, red iron oxide. Also 2 mg additionally contains FD & C Yellow # 6 and lake pigment D & C Yellow # 10.</Description>
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<ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Proficient Rx LP</LabelerName>
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<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamsulosin hydrochloride is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1).</IndicationAndUsage>
<Description>Tamsulosin hydrochloride, USP is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride, USP is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white to almost white powder that melts at approximately 227° to 228°C. It is slightly soluble in water, freely soluble in formic acid. The molecular formula of tamsulosin hydrochloride is C20H28N2O5SHCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule, USP* for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer dispersion, talc, triethyl citrate, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No 10, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. * Meets USP Dissolution Test 6.</Description>
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<PackageDescription>14 CAPSULE in 1 BOTTLE (71205-748-14) </PackageDescription>
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<ProductNDC>71205-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078938</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamsulosin hydrochloride is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1).</IndicationAndUsage>
<Description>Tamsulosin hydrochloride, USP is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride, USP is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white to almost white powder that melts at approximately 227° to 228°C. It is slightly soluble in water, freely soluble in formic acid. The molecular formula of tamsulosin hydrochloride is C20H28N2O5SHCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule, USP* for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer dispersion, talc, triethyl citrate, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No 10, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. * Meets USP Dissolution Test 6.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamsulosin hydrochloride is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1).</IndicationAndUsage>
<Description>Tamsulosin hydrochloride, USP is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride, USP is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white to almost white powder that melts at approximately 227° to 228°C. It is slightly soluble in water, freely soluble in formic acid. The molecular formula of tamsulosin hydrochloride is C20H28N2O5SHCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule, USP* for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer dispersion, talc, triethyl citrate, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No 10, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. * Meets USP Dissolution Test 6.</Description>
</NDC>
<NDC>
<NDCCode>71205-748-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71205-748-60) </PackageDescription>
<NDC11Code>71205-0748-60</NDC11Code>
<ProductNDC>71205-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078938</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamsulosin hydrochloride is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1).</IndicationAndUsage>
<Description>Tamsulosin hydrochloride, USP is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride, USP is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white to almost white powder that melts at approximately 227° to 228°C. It is slightly soluble in water, freely soluble in formic acid. The molecular formula of tamsulosin hydrochloride is C20H28N2O5SHCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule, USP* for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer dispersion, talc, triethyl citrate, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No 10, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. * Meets USP Dissolution Test 6.</Description>
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<ProductNDC>71205-748</ProductNDC>
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<NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078938</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
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<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamsulosin hydrochloride is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1).</IndicationAndUsage>
<Description>Tamsulosin hydrochloride, USP is an antagonist of alpha1A adrenoceptors in the prostate. Tamsulosin hydrochloride, USP is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white to almost white powder that melts at approximately 227° to 228°C. It is slightly soluble in water, freely soluble in formic acid. The molecular formula of tamsulosin hydrochloride is C20H28N2O5SHCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule, USP* for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer dispersion, talc, triethyl citrate, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No 10, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. * Meets USP Dissolution Test 6.</Description>
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<Status>Deprecated</Status>
<LastUpdate>2023-09-29</LastUpdate>
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<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<ProprietaryName>Coffea Tosta</ProprietaryName>
<NonProprietaryName>Coffea Arabica Seed, Roasted</NonProprietaryName>
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<StartMarketingDate>20100203</StartMarketingDate>
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<SubstanceName>COFFEA ARABICA SEED, ROASTED</SubstanceName>
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<LastUpdate>2020-12-29</LastUpdate>
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<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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