{
"NDC": [
{
"NDCCode": "77008-5714-1",
"PackageDescription": "1 g in 1 PACKAGE (77008-5714-1) ",
"NDC11Code": "77008-5714-01",
"ProductNDC": "77008-5714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hankki Ssog Pre-biome Shake (detox And Diet, Body Change)",
"NonProprietaryName": "Dietary Fiber, Cellulose Fiber, Probiotic",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240224",
"EndMarketingDate": "20250223",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BIOHERB Co., Ltd.",
"SubstanceName": "COTTON FIBER; LACTIC ACID; PEA FIBER",
"StrengthNumber": "5; 10; 5",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Acidifying Activity [MoA], Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Fiber Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240224",
"EndMarketingDatePackage": "20250223",
"SamplePackage": "N",
"IndicationAndUsage": "Fluids metabolism smooth. Blood metabolism smooth. Reducing body fat. Elimination of waste in blood. Remove swelling. Acquiring gastrointestinal satisfaction. Reducing food intake."
},
{
"NDCCode": "77008-0230-2",
"PackageDescription": "5 g in 1 POUCH (77008-0230-2) ",
"NDC11Code": "77008-0230-02",
"ProductNDC": "77008-0230",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ari S-liner",
"NonProprietaryName": "Garcinia Cambogia Extract Pwd",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BIOHERB Co., Ltd.",
"SubstanceName": "GARCINIA CAMBOGIA FRUIT",
"StrengthNumber": ".34",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200101",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "77008-0570-2",
"PackageDescription": "30 g in 1 DOSE PACK (77008-0570-2) ",
"NDC11Code": "77008-0570-02",
"ProductNDC": "77008-0570",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ari Moms Care",
"NonProprietaryName": "Asian Ginseng, Angelica Dahurica Root, Orange, Licorice",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20200101",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BIOHERB Co,, Ltd.",
"SubstanceName": "ASIAN GINSENG; ANGELICA DAHURICA ROOT; ORANGE; LICORICE",
"StrengthNumber": "1.2; .8; .8; .4",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200101",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "77008-0870-1",
"PackageDescription": "1 g in 1 PACKAGE (77008-0870-1) ",
"NDC11Code": "77008-0870-01",
"ProductNDC": "77008-0870",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Beverhill Hair Tonic",
"NonProprietaryName": "Undaria Pinnatifida Extract, Camellia Sinensis Leaf Extract, Morus Alba Bark Extract, Pinus Densiflora Leaf Extract, Artemisia Vulgaris Extract, Sesamum Indicum Seed Extract, Sodium Benzoate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250101",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BIOHERB Co., Ltd.",
"SubstanceName": "ALCOHOL; ARTEMISIA VULGARIS WHOLE; CAMELLIA SINENSIS WHOLE; MORUS ALBA BARK; PINUS DENSIFLORA LEAF; SESAMUM INDICUM WHOLE; SODIUM BENZOATE; UNDARIA PINNATIFIDA",
"StrengthNumber": "20; 1.793; 2.608; 1.793; 1.793; 1.793; .0815; 2.608",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250101",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Fluids metabolism smooth. Blood metabolism smooth. Reducing body fat. Elimination of waste in blood. Remove swelling. Acquiring gastrointestinal satisfaction. Reducing food intake."
},
{
"NDCCode": "77008-1530-1",
"PackageDescription": "30 g in 1 POUCH (77008-1530-1) ",
"NDC11Code": "77008-1530-01",
"ProductNDC": "77008-1530",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Super Cell Two",
"NonProprietaryName": "Mannitol, Modified Corn Starch",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20220326",
"EndMarketingDate": "20230325",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BIOHERB Co., Ltd.",
"SubstanceName": "MANNITOL; MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)",
"StrengthNumber": "2; 20",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-03-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220326",
"EndMarketingDatePackage": "20230325",
"SamplePackage": "N"
},
{
"NDCCode": "77008-1536-4",
"PackageDescription": "100 g in 1 PACKAGE (77008-1536-4) ",
"NDC11Code": "77008-1536-04",
"ProductNDC": "77008-1536",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salana 153 (blood Circulation, Cytothesis, Thrombolysis, Immunity Boost, An Antitumor, Antiinflammatory, Regulatory Action, Inhibitory Action, Exocytosis)",
"NonProprietaryName": "Norugung Dew Mushroom",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260520",
"EndMarketingDate": "20270519",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BIOHERB Co., Ltd.",
"SubstanceName": "SHIITAKE MUSHROOM",
"StrengthNumber": "15",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20260520",
"EndMarketingDatePackage": "20270519",
"SamplePackage": "N",
"IndicationAndUsage": "Blood circulation improvement. Thrombolysis. Promote cell restoration. Immunity boost. An anti tumor. Antiinflammatory."
},
{
"NDCCode": "77008-2298-1",
"PackageDescription": "1 g in 1 PACKAGE (77008-2298-1) ",
"NDC11Code": "77008-2298-01",
"ProductNDC": "77008-2298",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Manna Dd Tea (detox And Diet Tea)",
"NonProprietaryName": "Allium Hookeri",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20250224",
"EndMarketingDate": "20260223",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BIOHERB Co., Ltd.",
"SubstanceName": "ALLIUM HOOKERI WHOLE",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250224",
"EndMarketingDatePackage": "20260223",
"SamplePackage": "N",
"IndicationAndUsage": "Fluids metabolism smooth. Blood metabolism smooth. Reducing body fat. Elimination of waste in blood. Remove swelling. Acquiring gastrointestinal satisfaction. Reducing food intake."
},
{
"NDCCode": "77008-3194-3",
"PackageDescription": "120 g in 1 PACKAGE (77008-3194-3) ",
"NDC11Code": "77008-3194-03",
"ProductNDC": "77008-3194",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Beverhill Micro-biome Scalp Cooling Essence (prevention Of Hair Loss, Trouble Scalp Treatment, Treatment Of Itching)",
"NonProprietaryName": "Undaria Pinnatifida Extract, Camellia Sinensis Leaf Extract, Morus Alba Bark Extract, Pinus Densiflora Leaf Extract, Artemisia Vulgaris Extract, Sesamum Indicum Seed Extract, Sodium Benzoate",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240328",
"EndMarketingDate": "20250327",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BIOHERB Co., Ltd.",
"SubstanceName": "ALCOHOL; ARTEMISIA VULGARIS WHOLE; CAMELLIA SINENSIS WHOLE; MORUS ALBA BARK; PINUS DENSIFLORA LEAF; SESAMUM INDICUM WHOLE; SODIUM BENZOATE; UNDARIA PINNATIFIDA",
"StrengthNumber": "20; 1.793; 2.608; 1.793; 1.793; 1.793; .0815; 2.608",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240328",
"EndMarketingDatePackage": "20250327",
"SamplePackage": "N",
"IndicationAndUsage": "Fluids metabolism smooth. Blood metabolism smooth. Reducing body fat. Elimination of waste in blood. Remove swelling. Acquiring gastrointestinal satisfaction. Reducing food intake."
},
{
"NDCCode": "77008-4285-1",
"PackageDescription": "24 g in 1 PACKAGE (77008-4285-1) ",
"NDC11Code": "77008-4285-01",
"ProductNDC": "77008-4285",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chi. Joa (anti-inflammatory Effect, Antibacterial Effect, Stomatitis Improvement, Plaque Removal)",
"NonProprietaryName": "Sea Salt, Bamboo Salt, Lactobacillus Powder",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230711",
"EndMarketingDate": "20240710",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BIOHERB Co., Ltd.",
"SubstanceName": "CINNAMON; LEVOMENTHOL; MENTHOL; MYRRH; PEAR; PEPPERMINT; SEA SALT; SILICON DIOXIDE; SORBITOL; XYLITOL",
"StrengthNumber": "1; 1; 1; 1; 1; 1; 47; 1; 1; 1",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Food Additives [CS], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230711",
"EndMarketingDatePackage": "20240710",
"SamplePackage": "N",
"IndicationAndUsage": "Fluids metabolism smooth. Blood metabolism smooth. Reducing body fat. Elimination of waste in blood. Remove swelling. Acquiring gastrointestinal satisfaction. Reducing food intake."
},
{
"NDCCode": "77008-5712-1",
"PackageDescription": "1 g in 1 PACKAGE (77008-5712-1) ",
"NDC11Code": "77008-5712-01",
"ProductNDC": "77008-5712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hankki Ssog Pre-biome Shake (detox And Diet Shake)",
"NonProprietaryName": "Dietary Fiber, Cellulose Fiber, Probiotic",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250224",
"EndMarketingDate": "20260225",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BIOHERB Co., Ltd.",
"SubstanceName": "COTTON FIBER; LACTIC ACID; PEA FIBER",
"StrengthNumber": "5; 10; 5",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Acidifying Activity [MoA], Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Fiber Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250224",
"EndMarketingDatePackage": "20260225",
"SamplePackage": "N",
"IndicationAndUsage": "Fluids metabolism smooth. Blood metabolism smooth. Reducing body fat. Elimination of waste in blood. Remove swelling. Acquiring gastrointestinal satisfaction. Reducing food intake."
},
{
"NDCCode": "77008-6751-1",
"PackageDescription": "1 g in 1 PACKAGE (77008-6751-1) ",
"NDC11Code": "77008-6751-01",
"ProductNDC": "77008-6751",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gaezoa Cream",
"NonProprietaryName": "Poterium Officinale Root Extract, Camellia Sinensis Leaf, Elaeagnus Glabra Extract",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251230",
"EndMarketingDate": "20261229",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BIOHERB Co., Ltd.",
"SubstanceName": "CAMELLIA SINENSIS LEAF; HYALURONIC ACID; GLYCERIN",
"StrengthNumber": "3.2; .64; 16",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20251230",
"EndMarketingDatePackage": "20261229",
"SamplePackage": "N",
"IndicationAndUsage": "Take an appropriate amount and apply evenly to the needed areas as often as necessary."
},
{
"NDCCode": "77008-8112-3",
"PackageDescription": "1500 g in 1 PACKAGE (77008-8112-3) ",
"NDC11Code": "77008-8112-03",
"ProductNDC": "77008-8112",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nina Water (rich Anions)",
"NonProprietaryName": "Water",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260101",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BIOHERB Co., Ltd.",
"SubstanceName": "OXYGEN",
"StrengthNumber": ".0029",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20260101",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Mixed drink."
},
{
"NDCCode": "0591-5714-00",
"PackageDescription": "57100 TABLET in 1 BAG (0591-5714-00) ",
"NDC11Code": "00591-5714-00",
"ProductNDC": "0591-5714",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Amoxapine",
"DosageFormName": "TABLET",
"StartMarketingDate": "19920828",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "AMOXAPINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "28-AUG-92"
},
{
"NDCCode": "0591-5714-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0591-5714-01) ",
"NDC11Code": "00591-5714-01",
"ProductNDC": "0591-5714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxapine",
"NonProprietaryName": "Amoxapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072691",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "AMOXAPINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920828",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxapine is indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions. It is indicated for depression accompanied by anxiety or agitation.",
"Description": "Amoxapine, USP is an antidepressant of the dibenzoxazepine class, chemically distinct from the dibenzazepines, dibenzocycloheptenes, and dibenzoxepines. It is designated chemically as 2-Chloro-11-(1-piperazinyl)dibenz[b,f][1,4]oxazepine. The structural formula is represented below. C17H16CIN3O M.W. 313.78. Amoxapine is supplied for oral administration as 25 mg, 50 mg, 100 mg and 150 mg tablets. Amoxapine tablets USP, 25 mg, 50 mg, 100 mg and 150 mg contain: dibasic calcium phosphate, magnesium stearate, pregelatinized (corn) starch, and stearic acid. Amoxapine tablets USP, 50 mg and 150 mg also contain: FD&C Yellow No. 6 Aluminum Lake. Amoxapine tablets USP, 100 mg also contain: FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "0591-5714-77",
"PackageDescription": "68568 TABLET in 1 CONTAINER (0591-5714-77) ",
"NDC11Code": "00591-5714-77",
"ProductNDC": "0591-5714",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Amoxapine",
"DosageFormName": "TABLET",
"StartMarketingDate": "19920828",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "AMOXAPINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-03-07",
"StartMarketingDatePackage": "31-JUL-24",
"EndMarketingDatePackage": "30-JUN-27"
},
{
"NDCCode": "22840-5714-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-5714-2) ",
"NDC11Code": "22840-5714-02",
"ProductNDC": "22840-5714",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Celery",
"NonProprietaryName": "Apium Graveolens Var. Dulce",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "CELERY",
"StrengthNumber": ".025",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for: 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "22840-5714-5",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (22840-5714-5) ",
"NDC11Code": "22840-5714-05",
"ProductNDC": "22840-5714",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Celery",
"NonProprietaryName": "Apium Graveolens Var. Dulce",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "CELERY",
"StrengthNumber": ".025",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for: 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "62670-5714-0",
"PackageDescription": "29 mL in 1 BOTTLE (62670-5714-0) ",
"NDC11Code": "62670-5714-00",
"ProductNDC": "62670-5714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Flannel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191206",
"EndMarketingDate": "20200606",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191206",
"EndMarketingDatePackage": "20200606",
"SamplePackage": "N"
},
{
"NDCCode": "62670-5714-1",
"PackageDescription": "73 mL in 1 BOTTLE (62670-5714-1) ",
"NDC11Code": "62670-5714-01",
"ProductNDC": "62670-5714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Flannel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191206",
"EndMarketingDate": "20200606",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191206",
"EndMarketingDatePackage": "20200606",
"SamplePackage": "N"
},
{
"NDCCode": "62670-5714-3",
"PackageDescription": "236 mL in 1 BOTTLE, PUMP (62670-5714-3) ",
"NDC11Code": "62670-5714-03",
"ProductNDC": "62670-5714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Flannel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191206",
"EndMarketingDate": "20200606",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191206",
"EndMarketingDatePackage": "20200606",
"SamplePackage": "N"
},
{
"NDCCode": "64542-001-01",
"PackageDescription": "70 PATCH in 1 CANISTER (64542-001-01) > 3.5714 mL in 1 PATCH",
"NDC11Code": "64542-0001-01",
"ProductNDC": "64542-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutron Ni Defense Alcohol Sanitary Wipes",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "State Industrial Products Corporation",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer. Effective in killing harmful bacteria and germs to provide antiseptic cleansing. For use when soap and water are not available."
},
{
"NDCCode": "64542-002-01",
"PackageDescription": "70 PATCH in 1 CANISTER (64542-002-01) > 3.5714 mL in 1 PATCH",
"NDC11Code": "64542-0002-01",
"ProductNDC": "64542-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "State Quick Defense Alcohol Sanitary Wipes",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "State Industrial Products Corporation",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer. Effective in killing harmful bacteria and germs to provide antiseptic cleansing. For use when soap and water are not available."
},
{
"NDCCode": "22840-0222-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0222-2) ",
"NDC11Code": "22840-0222-02",
"ProductNDC": "22840-0222",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "7 Standardized Grass Pollen Mix",
"NonProprietaryName": "Poa Pratensis, Festuca Elatior, Dactylis Glomerata, Lolium Perenne, Agrositis Alba, Anthoxanthum Odoratum, And Phleum Pratense",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19680915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101837",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM PERENNE POLLEN; LOLIUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN",
"StrengthNumber": "1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714",
"StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19680915",
"SamplePackage": "N",
"IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
"Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "22840-0222-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0222-4) ",
"NDC11Code": "22840-0222-04",
"ProductNDC": "22840-0222",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "7 Standardized Grass Pollen Mix",
"NonProprietaryName": "Poa Pratensis, Festuca Elatior, Dactylis Glomerata, Lolium Perenne, Agrositis Alba, Anthoxanthum Odoratum, And Phleum Pratense",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19680915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101837",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM PERENNE POLLEN; LOLIUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN",
"StrengthNumber": "1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714",
"StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19680915",
"SamplePackage": "N",
"IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
"Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "22840-0222-5",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (22840-0222-5) ",
"NDC11Code": "22840-0222-05",
"ProductNDC": "22840-0222",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "7 Standardized Grass Pollen Mix",
"NonProprietaryName": "Poa Pratensis, Festuca Elatior, Dactylis Glomerata, Lolium Perenne, Agrositis Alba, Anthoxanthum Odoratum, And Phleum Pratense",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19680915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101837",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM PERENNE POLLEN; LOLIUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN",
"StrengthNumber": "1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714",
"StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19680915",
"SamplePackage": "N",
"IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
"Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "22840-9458-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-9458-4) ",
"NDC11Code": "22840-9458-04",
"ProductNDC": "22840-9458",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Eastern 7 Tree Pollen Mix",
"NonProprietaryName": "Ulmus Americana, Fagus Grandifolia, Populus Deltoides, Quercus Rubra, Betula Nigra, Carya Ovata And Fraxinus Americana",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "ULMUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; CARYA OVATA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA NIGRA POLLEN",
"StrengthNumber": "5714.2857; 5714.2857; 5714.2857; 5714.2857; 5714.2857; 5714.2857; 5714.2857",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "0002-0013-03",
"PackageDescription": "3 mL in 1 VIAL, MULTI-DOSE (0002-0013-03) ",
"NDC11Code": "00002-0013-03",
"ProductNDC": "0002-0013",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "19830627",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Status": "Unfinished",
"LastUpdate": "2022-03-05",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "04-DEC-09"
},
{
"NDCCode": "0002-0013-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0002-0013-10) ",
"NDC11Code": "00002-0013-10",
"ProductNDC": "0002-0013",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "19830627",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Status": "Unfinished",
"LastUpdate": "2022-03-05",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "27-JUN-83"
},
{
"NDCCode": "0002-0095-00",
"PackageDescription": "3 mL in 1 SYRINGE (0002-0095-00) ",
"NDC11Code": "00002-0095-00",
"ProductNDC": "0002-0095",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20151229",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "500",
"StrengthUnit": "[iU]/mL",
"Status": "Unfinished",
"LastUpdate": "2022-03-05",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "29-DEC-15"
},
{
"NDCCode": "0002-0096-00",
"PackageDescription": "20 mL in 1 VIAL, MULTI-DOSE (0002-0096-00) ",
"NDC11Code": "00002-0096-00",
"ProductNDC": "0002-0096",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "19940331",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "500",
"StrengthUnit": "[iU]/mL",
"Status": "Unfinished",
"LastUpdate": "2022-03-05",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "06-JAN-97"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>77008-5714-1</NDCCode>
<PackageDescription>1 g in 1 PACKAGE (77008-5714-1) </PackageDescription>
<NDC11Code>77008-5714-01</NDC11Code>
<ProductNDC>77008-5714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hankki Ssog Pre-biome Shake (detox And Diet, Body Change)</ProprietaryName>
<NonProprietaryName>Dietary Fiber, Cellulose Fiber, Probiotic</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240224</StartMarketingDate>
<EndMarketingDate>20250223</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BIOHERB Co., Ltd.</LabelerName>
<SubstanceName>COTTON FIBER; LACTIC ACID; PEA FIBER</SubstanceName>
<StrengthNumber>5; 10; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Fiber Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240224</StartMarketingDatePackage>
<EndMarketingDatePackage>20250223</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluids metabolism smooth. Blood metabolism smooth. Reducing body fat. Elimination of waste in blood. Remove swelling. Acquiring gastrointestinal satisfaction. Reducing food intake.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77008-0230-2</NDCCode>
<PackageDescription>5 g in 1 POUCH (77008-0230-2) </PackageDescription>
<NDC11Code>77008-0230-02</NDC11Code>
<ProductNDC>77008-0230</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ari S-liner</ProprietaryName>
<NonProprietaryName>Garcinia Cambogia Extract Pwd</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BIOHERB Co., Ltd.</LabelerName>
<SubstanceName>GARCINIA CAMBOGIA FRUIT</SubstanceName>
<StrengthNumber>.34</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>77008-0570-2</NDCCode>
<PackageDescription>30 g in 1 DOSE PACK (77008-0570-2) </PackageDescription>
<NDC11Code>77008-0570-02</NDC11Code>
<ProductNDC>77008-0570</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ari Moms Care</ProprietaryName>
<NonProprietaryName>Asian Ginseng, Angelica Dahurica Root, Orange, Licorice</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BIOHERB Co,, Ltd.</LabelerName>
<SubstanceName>ASIAN GINSENG; ANGELICA DAHURICA ROOT; ORANGE; LICORICE</SubstanceName>
<StrengthNumber>1.2; .8; .8; .4</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>77008-0870-1</NDCCode>
<PackageDescription>1 g in 1 PACKAGE (77008-0870-1) </PackageDescription>
<NDC11Code>77008-0870-01</NDC11Code>
<ProductNDC>77008-0870</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Beverhill Hair Tonic</ProprietaryName>
<NonProprietaryName>Undaria Pinnatifida Extract, Camellia Sinensis Leaf Extract, Morus Alba Bark Extract, Pinus Densiflora Leaf Extract, Artemisia Vulgaris Extract, Sesamum Indicum Seed Extract, Sodium Benzoate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BIOHERB Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL; ARTEMISIA VULGARIS WHOLE; CAMELLIA SINENSIS WHOLE; MORUS ALBA BARK; PINUS DENSIFLORA LEAF; SESAMUM INDICUM WHOLE; SODIUM BENZOATE; UNDARIA PINNATIFIDA</SubstanceName>
<StrengthNumber>20; 1.793; 2.608; 1.793; 1.793; 1.793; .0815; 2.608</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluids metabolism smooth. Blood metabolism smooth. Reducing body fat. Elimination of waste in blood. Remove swelling. Acquiring gastrointestinal satisfaction. Reducing food intake.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77008-1530-1</NDCCode>
<PackageDescription>30 g in 1 POUCH (77008-1530-1) </PackageDescription>
<NDC11Code>77008-1530-01</NDC11Code>
<ProductNDC>77008-1530</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Super Cell Two</ProprietaryName>
<NonProprietaryName>Mannitol, Modified Corn Starch</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220326</StartMarketingDate>
<EndMarketingDate>20230325</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BIOHERB Co., Ltd.</LabelerName>
<SubstanceName>MANNITOL; MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)</SubstanceName>
<StrengthNumber>2; 20</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220326</StartMarketingDatePackage>
<EndMarketingDatePackage>20230325</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>77008-1536-4</NDCCode>
<PackageDescription>100 g in 1 PACKAGE (77008-1536-4) </PackageDescription>
<NDC11Code>77008-1536-04</NDC11Code>
<ProductNDC>77008-1536</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salana 153 (blood Circulation, Cytothesis, Thrombolysis, Immunity Boost, An Antitumor, Antiinflammatory, Regulatory Action, Inhibitory Action, Exocytosis)</ProprietaryName>
<NonProprietaryName>Norugung Dew Mushroom</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260520</StartMarketingDate>
<EndMarketingDate>20270519</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BIOHERB Co., Ltd.</LabelerName>
<SubstanceName>SHIITAKE MUSHROOM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20260520</StartMarketingDatePackage>
<EndMarketingDatePackage>20270519</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Blood circulation improvement. Thrombolysis. Promote cell restoration. Immunity boost. An anti tumor. Antiinflammatory.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77008-2298-1</NDCCode>
<PackageDescription>1 g in 1 PACKAGE (77008-2298-1) </PackageDescription>
<NDC11Code>77008-2298-01</NDC11Code>
<ProductNDC>77008-2298</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Manna Dd Tea (detox And Diet Tea)</ProprietaryName>
<NonProprietaryName>Allium Hookeri</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250224</StartMarketingDate>
<EndMarketingDate>20260223</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BIOHERB Co., Ltd.</LabelerName>
<SubstanceName>ALLIUM HOOKERI WHOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250224</StartMarketingDatePackage>
<EndMarketingDatePackage>20260223</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluids metabolism smooth. Blood metabolism smooth. Reducing body fat. Elimination of waste in blood. Remove swelling. Acquiring gastrointestinal satisfaction. Reducing food intake.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77008-3194-3</NDCCode>
<PackageDescription>120 g in 1 PACKAGE (77008-3194-3) </PackageDescription>
<NDC11Code>77008-3194-03</NDC11Code>
<ProductNDC>77008-3194</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Beverhill Micro-biome Scalp Cooling Essence (prevention Of Hair Loss, Trouble Scalp Treatment, Treatment Of Itching)</ProprietaryName>
<NonProprietaryName>Undaria Pinnatifida Extract, Camellia Sinensis Leaf Extract, Morus Alba Bark Extract, Pinus Densiflora Leaf Extract, Artemisia Vulgaris Extract, Sesamum Indicum Seed Extract, Sodium Benzoate</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240328</StartMarketingDate>
<EndMarketingDate>20250327</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BIOHERB Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL; ARTEMISIA VULGARIS WHOLE; CAMELLIA SINENSIS WHOLE; MORUS ALBA BARK; PINUS DENSIFLORA LEAF; SESAMUM INDICUM WHOLE; SODIUM BENZOATE; UNDARIA PINNATIFIDA</SubstanceName>
<StrengthNumber>20; 1.793; 2.608; 1.793; 1.793; 1.793; .0815; 2.608</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240328</StartMarketingDatePackage>
<EndMarketingDatePackage>20250327</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluids metabolism smooth. Blood metabolism smooth. Reducing body fat. Elimination of waste in blood. Remove swelling. Acquiring gastrointestinal satisfaction. Reducing food intake.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77008-4285-1</NDCCode>
<PackageDescription>24 g in 1 PACKAGE (77008-4285-1) </PackageDescription>
<NDC11Code>77008-4285-01</NDC11Code>
<ProductNDC>77008-4285</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chi. Joa (anti-inflammatory Effect, Antibacterial Effect, Stomatitis Improvement, Plaque Removal)</ProprietaryName>
<NonProprietaryName>Sea Salt, Bamboo Salt, Lactobacillus Powder</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230711</StartMarketingDate>
<EndMarketingDate>20240710</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BIOHERB Co., Ltd.</LabelerName>
<SubstanceName>CINNAMON; LEVOMENTHOL; MENTHOL; MYRRH; PEAR; PEPPERMINT; SEA SALT; SILICON DIOXIDE; SORBITOL; XYLITOL</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 1; 1; 47; 1; 1; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Food Additives [CS], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230711</StartMarketingDatePackage>
<EndMarketingDatePackage>20240710</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluids metabolism smooth. Blood metabolism smooth. Reducing body fat. Elimination of waste in blood. Remove swelling. Acquiring gastrointestinal satisfaction. Reducing food intake.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77008-5712-1</NDCCode>
<PackageDescription>1 g in 1 PACKAGE (77008-5712-1) </PackageDescription>
<NDC11Code>77008-5712-01</NDC11Code>
<ProductNDC>77008-5712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hankki Ssog Pre-biome Shake (detox And Diet Shake)</ProprietaryName>
<NonProprietaryName>Dietary Fiber, Cellulose Fiber, Probiotic</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250224</StartMarketingDate>
<EndMarketingDate>20260225</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BIOHERB Co., Ltd.</LabelerName>
<SubstanceName>COTTON FIBER; LACTIC ACID; PEA FIBER</SubstanceName>
<StrengthNumber>5; 10; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Fiber Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250224</StartMarketingDatePackage>
<EndMarketingDatePackage>20260225</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluids metabolism smooth. Blood metabolism smooth. Reducing body fat. Elimination of waste in blood. Remove swelling. Acquiring gastrointestinal satisfaction. Reducing food intake.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77008-6751-1</NDCCode>
<PackageDescription>1 g in 1 PACKAGE (77008-6751-1) </PackageDescription>
<NDC11Code>77008-6751-01</NDC11Code>
<ProductNDC>77008-6751</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gaezoa Cream</ProprietaryName>
<NonProprietaryName>Poterium Officinale Root Extract, Camellia Sinensis Leaf, Elaeagnus Glabra Extract</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251230</StartMarketingDate>
<EndMarketingDate>20261229</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BIOHERB Co., Ltd.</LabelerName>
<SubstanceName>CAMELLIA SINENSIS LEAF; HYALURONIC ACID; GLYCERIN</SubstanceName>
<StrengthNumber>3.2; .64; 16</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20251230</StartMarketingDatePackage>
<EndMarketingDatePackage>20261229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Take an appropriate amount and apply evenly to the needed areas as often as necessary.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77008-8112-3</NDCCode>
<PackageDescription>1500 g in 1 PACKAGE (77008-8112-3) </PackageDescription>
<NDC11Code>77008-8112-03</NDC11Code>
<ProductNDC>77008-8112</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nina Water (rich Anions)</ProprietaryName>
<NonProprietaryName>Water</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BIOHERB Co., Ltd.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>.0029</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mixed drink.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0591-5714-00</NDCCode>
<PackageDescription>57100 TABLET in 1 BAG (0591-5714-00) </PackageDescription>
<NDC11Code>00591-5714-00</NDC11Code>
<ProductNDC>0591-5714</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Amoxapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>19920828</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>AMOXAPINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>28-AUG-92</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0591-5714-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0591-5714-01) </PackageDescription>
<NDC11Code>00591-5714-01</NDC11Code>
<ProductNDC>0591-5714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxapine</ProprietaryName>
<NonProprietaryName>Amoxapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072691</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>AMOXAPINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxapine is indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions. It is indicated for depression accompanied by anxiety or agitation.</IndicationAndUsage>
<Description>Amoxapine, USP is an antidepressant of the dibenzoxazepine class, chemically distinct from the dibenzazepines, dibenzocycloheptenes, and dibenzoxepines. It is designated chemically as 2-Chloro-11-(1-piperazinyl)dibenz[b,f][1,4]oxazepine. The structural formula is represented below. C17H16CIN3O M.W. 313.78. Amoxapine is supplied for oral administration as 25 mg, 50 mg, 100 mg and 150 mg tablets. Amoxapine tablets USP, 25 mg, 50 mg, 100 mg and 150 mg contain: dibasic calcium phosphate, magnesium stearate, pregelatinized (corn) starch, and stearic acid. Amoxapine tablets USP, 50 mg and 150 mg also contain: FD&C Yellow No. 6 Aluminum Lake. Amoxapine tablets USP, 100 mg also contain: FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0591-5714-77</NDCCode>
<PackageDescription>68568 TABLET in 1 CONTAINER (0591-5714-77) </PackageDescription>
<NDC11Code>00591-5714-77</NDC11Code>
<ProductNDC>0591-5714</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Amoxapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>19920828</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>AMOXAPINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-07</LastUpdate>
<StartMarketingDatePackage>31-JUL-24</StartMarketingDatePackage>
<EndMarketingDatePackage>30-JUN-27</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>22840-5714-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-5714-2) </PackageDescription>
<NDC11Code>22840-5714-02</NDC11Code>
<ProductNDC>22840-5714</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Celery</ProprietaryName>
<NonProprietaryName>Apium Graveolens Var. Dulce</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>CELERY</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for: 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>22840-5714-5</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (22840-5714-5) </PackageDescription>
<NDC11Code>22840-5714-05</NDC11Code>
<ProductNDC>22840-5714</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Celery</ProprietaryName>
<NonProprietaryName>Apium Graveolens Var. Dulce</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>CELERY</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for: 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>62670-5714-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-5714-0) </PackageDescription>
<NDC11Code>62670-5714-00</NDC11Code>
<ProductNDC>62670-5714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Flannel</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191206</StartMarketingDate>
<EndMarketingDate>20200606</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191206</StartMarketingDatePackage>
<EndMarketingDatePackage>20200606</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62670-5714-1</NDCCode>
<PackageDescription>73 mL in 1 BOTTLE (62670-5714-1) </PackageDescription>
<NDC11Code>62670-5714-01</NDC11Code>
<ProductNDC>62670-5714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Flannel</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191206</StartMarketingDate>
<EndMarketingDate>20200606</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191206</StartMarketingDatePackage>
<EndMarketingDatePackage>20200606</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62670-5714-3</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PUMP (62670-5714-3) </PackageDescription>
<NDC11Code>62670-5714-03</NDC11Code>
<ProductNDC>62670-5714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Flannel</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191206</StartMarketingDate>
<EndMarketingDate>20200606</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191206</StartMarketingDatePackage>
<EndMarketingDatePackage>20200606</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64542-001-01</NDCCode>
<PackageDescription>70 PATCH in 1 CANISTER (64542-001-01) > 3.5714 mL in 1 PATCH</PackageDescription>
<NDC11Code>64542-0001-01</NDC11Code>
<ProductNDC>64542-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutron Ni Defense Alcohol Sanitary Wipes</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>State Industrial Products Corporation</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer. Effective in killing harmful bacteria and germs to provide antiseptic cleansing. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64542-002-01</NDCCode>
<PackageDescription>70 PATCH in 1 CANISTER (64542-002-01) > 3.5714 mL in 1 PATCH</PackageDescription>
<NDC11Code>64542-0002-01</NDC11Code>
<ProductNDC>64542-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>State Quick Defense Alcohol Sanitary Wipes</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>State Industrial Products Corporation</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer. Effective in killing harmful bacteria and germs to provide antiseptic cleansing. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>22840-0222-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-0222-2) </PackageDescription>
<NDC11Code>22840-0222-02</NDC11Code>
<ProductNDC>22840-0222</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>7 Standardized Grass Pollen Mix</ProprietaryName>
<NonProprietaryName>Poa Pratensis, Festuca Elatior, Dactylis Glomerata, Lolium Perenne, Agrositis Alba, Anthoxanthum Odoratum, And Phleum Pratense</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19680915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101837</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM PERENNE POLLEN; LOLIUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
<StrengthNumber>1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714</StrengthNumber>
<StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19680915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
<Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>22840-0222-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0222-4) </PackageDescription>
<NDC11Code>22840-0222-04</NDC11Code>
<ProductNDC>22840-0222</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>7 Standardized Grass Pollen Mix</ProprietaryName>
<NonProprietaryName>Poa Pratensis, Festuca Elatior, Dactylis Glomerata, Lolium Perenne, Agrositis Alba, Anthoxanthum Odoratum, And Phleum Pratense</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19680915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101837</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM PERENNE POLLEN; LOLIUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
<StrengthNumber>1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714</StrengthNumber>
<StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19680915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
<Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>22840-0222-5</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (22840-0222-5) </PackageDescription>
<NDC11Code>22840-0222-05</NDC11Code>
<ProductNDC>22840-0222</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>7 Standardized Grass Pollen Mix</ProprietaryName>
<NonProprietaryName>Poa Pratensis, Festuca Elatior, Dactylis Glomerata, Lolium Perenne, Agrositis Alba, Anthoxanthum Odoratum, And Phleum Pratense</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19680915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101837</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM PERENNE POLLEN; LOLIUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
<StrengthNumber>1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714</StrengthNumber>
<StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19680915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
<Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>22840-9458-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-9458-4) </PackageDescription>
<NDC11Code>22840-9458-04</NDC11Code>
<ProductNDC>22840-9458</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Eastern 7 Tree Pollen Mix</ProprietaryName>
<NonProprietaryName>Ulmus Americana, Fagus Grandifolia, Populus Deltoides, Quercus Rubra, Betula Nigra, Carya Ovata And Fraxinus Americana</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>ULMUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; CARYA OVATA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA NIGRA POLLEN</SubstanceName>
<StrengthNumber>5714.2857; 5714.2857; 5714.2857; 5714.2857; 5714.2857; 5714.2857; 5714.2857</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>0002-0013-03</NDCCode>
<PackageDescription>3 mL in 1 VIAL, MULTI-DOSE (0002-0013-03) </PackageDescription>
<NDC11Code>00002-0013-03</NDC11Code>
<ProductNDC>0002-0013</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>19830627</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-03-05</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-DEC-09</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0002-0013-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0002-0013-10) </PackageDescription>
<NDC11Code>00002-0013-10</NDC11Code>
<ProductNDC>0002-0013</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>19830627</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-03-05</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-JUN-83</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0002-0095-00</NDCCode>
<PackageDescription>3 mL in 1 SYRINGE (0002-0095-00) </PackageDescription>
<NDC11Code>00002-0095-00</NDC11Code>
<ProductNDC>0002-0095</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20151229</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-03-05</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-DEC-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0002-0096-00</NDCCode>
<PackageDescription>20 mL in 1 VIAL, MULTI-DOSE (0002-0096-00) </PackageDescription>
<NDC11Code>00002-0096-00</NDC11Code>
<ProductNDC>0002-0096</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>19940331</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-03-05</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-JAN-97</StartMarketingDatePackage>
</NDC>
</NDCList>