{
"NDC": [
{
"NDCCode": "57955-2311-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-2311-2)",
"NDC11Code": "57955-2311-02",
"ProductNDC": "57955-2311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calloused",
"NonProprietaryName": "Allium Sativum, Anacardium Orientale, Calendula Officinalis, Capsicum Annuum, Ceanothus Americanus, Chamomilla, Chelidonium Majus, Conium Maculatum, Kali Carbonicum, Lobelia Cardinalis, Mancinella, Myristica Sebifera, Pinus Sylvestris, Flos, Stigmata Maidis, Sepia, Taraxacum Officinale, Thea Sinensis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "GARLIC; SEMECARPUS ANACARDIUM JUICE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; CEANOTHUS AMERICANUS LEAF; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; POTASSIUM CARBONATE; LOBELIA CARDINALIS; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; VIROLA SEBIFERA RESIN; PINUS SYLVESTRIS FLOWERING TOP; CORN SILK; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; GREEN TEA LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: hard-heartedness, fear of losing control. indifference, coldness toward others."
},
{
"NDCCode": "0548-2311-00",
"PackageDescription": "1 SYRINGE in 1 CARTON (0548-2311-00) / 2.24 mL in 1 SYRINGE",
"NDC11Code": "00548-2311-00",
"ProductNDC": "0548-2311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriparatide",
"NonProprietaryName": "Teriparatide",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213641",
"LabelerName": "Amphastar Pharmaceuticals, Inc.",
"SubstanceName": "TERIPARATIDE",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251222",
"SamplePackage": "N",
"IndicationAndUsage": "Teriparatide injection is indicated: 1 For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Teriparatide injection reduces the risk of vertebral and nonvertebral fractures., 2 To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy., 3 For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.",
"Description": "Teriparatide injection is a synthetic parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide is C181H291N55O51S2 and molecular weight is 4117.8 daltons. Its amino acid sequence is shown below. Teriparatide is manufactured using synthetic technology. Teriparatide injection is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each delivery device (pen) is filled with volume to allow delivery of 2.24 mL. Each mL contains 250 mcg of teriparatide (as a free base), 0.41 mg of glacial acetic acid, 0.1 mg of sodium acetate (anhydrous), 45.4 mg of mannitol, 3 mg of Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the pH to 4. Each prefilled delivery device (pen) delivers 20 mcg of teriparatide per dose for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times."
},
{
"NDCCode": "15631-2311-2",
"PackageDescription": "1 CONTAINER in 1 CONTAINER (15631-2311-2) > 200 g in 1 CONTAINER",
"NDC11Code": "15631-2311-02",
"ProductNDC": "15631-2311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cantharis",
"NonProprietaryName": "Cantharis",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160330",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "LYTTA VESICATORIA",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "22840-2311-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-2311-2) ",
"NDC11Code": "22840-2311-02",
"ProductNDC": "22840-2311",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Common Sagebrush",
"NonProprietaryName": "Artemisia Tridentata",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "ARTEMISIA TRIDENTATA POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"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": "36987-2311-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2311-2)",
"NDC11Code": "36987-2311-02",
"ProductNDC": "36987-2311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Couch Quack Grass",
"NonProprietaryName": "Couch Quack Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ELYMUS REPENS POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2311-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-2311-2) ",
"NDC11Code": "37662-2311-02",
"ProductNDC": "37662-2311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thiosinaminum",
"NonProprietaryName": "Thiosinaminum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230111",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "ALLYLTHIOUREA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230111",
"SamplePackage": "N"
},
{
"NDCCode": "55714-2311-2",
"PackageDescription": "57 g in 1 BOTTLE, GLASS (55714-2311-2)",
"NDC11Code": "55714-2311-02",
"ProductNDC": "55714-2311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dust - Mold - Dander",
"NonProprietaryName": "Felis Catus Skin, Canis Lupus Familiaris Skin, Ortcyolagus Cuniculus Skin, Equus Caballus Skin, Serinus Canaria Feather, Gallus Gallus Feather, Anas Platyrhynchos Feather, Anser Anser Feather, Melopsittacus Undulatus Feather, Phasianus Colchicus Feather, Meleagris Gallopavo Feather, Felis Catus Hair, Human Dander, Canis Lupus Familiaris Hair, Equus Caballus Hair, Oryctolagus Cuniculus Hair, Human Hair, Human Skin, Sheep Wool, Bos Taurus Hair, Capra Hircus Hair, Cavia Porcellus Hair",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "FELIS CATUS SKIN; CANIS LUPUS FAMILIARIS SKIN; ORYCTOLAGUS CUNICULUS SKIN; EQUUS CABALLUS SKIN; SERINUS CANARIA FEATHER; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; MELOPSITTACUS UNDULATUS FEATHER; PHASIANUS COLCHICUS FEATHER; MELEAGRIS GALLOPAVO FEATHER; FELIS CATUS HAIR; HUMAN DANDER; CANIS LUPUS FAMILIARIS HAIR; EQUUS CABALLUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; HUMAN HAIR; HUMAN SKIN; SHEEP WOOL; BOS TAURUS HAIR; CAPRA HIRCUS HAIR; CAVIA PORCELLUS HAIR; MESOCRICETUS AURATUS HAIR; WHEAT GLUTEN; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM HERBARUM; HOUSE DUST; CANDIDA ALBICANS; HISTAMINE DIHYDROCHLORIDE; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BLATTA ORIENTALIS; BROMINE; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Formulated for associated symptoms such as labored breathing, congestion, sneezing, runny nose, watery eyes and skin irritations."
},
{
"NDCCode": "65044-2311-2",
"PackageDescription": "10 mL in 1 VIAL (65044-2311-2) ",
"NDC11Code": "65044-2311-02",
"ProductNDC": "65044-2311",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Pollens - Weeds And Garden Plants, Ragweed. Western Ambrosia Psilostachya",
"NonProprietaryName": "Ragweed. Western Ambrosia Psilostachya",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19410419",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103888",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "AMBROSIA PSILOSTACHYA POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19410419",
"SamplePackage": "N",
"IndicationAndUsage": "NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.",
"Description": "Non-standardized allergenic extracts are labeled “No U.S. Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution. Product concentrations vary based on the source. Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents: casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements. Acetone and ether may be used as drying and de-fatting agents. Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas."
},
{
"NDCCode": "67296-2311-2",
"PackageDescription": "15 TABLET in 1 BOTTLE (67296-2311-2) ",
"NDC11Code": "67296-2311-02",
"ProductNDC": "67296-2311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240507",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217566",
"LabelerName": "Redpharm Drug",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240507",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride tablets are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride tablets USP, is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form. Dicyclomine hydrochloride tablets USP, for oral use contain 20 mg dicyclomine hydrochloride USP. Dicyclomine hydrochloride 20 mg tablets also contain inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue #1, hypromellose, lactose monohydrate, sodium starch glycolate, and stearic acid. Dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid,2-(diethylamino) ethyl ester, hydrochloride with a molecular formula of C 19H 35NO 2HCl and the following structural formula:. Dicyclomine hydrochloride occurs as a fine, white, crystalline powder. It is soluble in water, freely soluble in alcohol and in chloroform and very slightly soluble in ether."
},
{
"NDCCode": "71335-2311-2",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (71335-2311-2) ",
"NDC11Code": "71335-2311-02",
"ProductNDC": "71335-2311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prazosin Hydrochloride",
"NonProprietaryName": "Prazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215697",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PRAZOSIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231221",
"SamplePackage": "N",
"IndicationAndUsage": "Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C19H21N5O4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0480-2311-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-2311-56) ",
"NDC11Code": "00480-2311-56",
"ProductNDC": "0480-2311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240116",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205885",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240116",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
"Description": "Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as oval-shaped film-coated tablets for oral administration. Each tablet contains 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sodium lauryl sulfate. The film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, talc, titanium dioxide, triacetin, and yellow iron oxide."
},
{
"NDCCode": "22840-2311-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-2311-4) ",
"NDC11Code": "22840-2311-04",
"ProductNDC": "22840-2311",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Common Sagebrush",
"NonProprietaryName": "Artemisia Tridentata",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "ARTEMISIA TRIDENTATA POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"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": "57955-0001-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0001-2)",
"NDC11Code": "57955-0001-02",
"ProductNDC": "57955-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eating Disorders",
"NonProprietaryName": "Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc",
"SubstanceName": "ANTIMONY TRISULFIDE; CINCHONA OFFICINALIS BARK; IRON; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for a natural aid for relief of: nausea, vomiting, loss of appetite, digestive tract disturbances and emotional sensitivity that may be associated with eating disorders."
},
{
"NDCCode": "57955-0002-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0002-2)",
"NDC11Code": "57955-0002-02",
"ProductNDC": "57955-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Birth Ease",
"NonProprietaryName": "Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: Muscular pains, stinging pain, tenderness over abdomen, vaginal dryness and heat, tender nipples, spasmodic labor pains, restlessness, extreme backache."
},
{
"NDCCode": "57955-0003-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0003-2)",
"NDC11Code": "57955-0003-02",
"ProductNDC": "57955-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Breast Cyst And Discomforts",
"NonProprietaryName": "Aconitum Napellus, Bellis Perennis, Bromium, Bryonia, Chamomilla, Conium Maculatum, Iodium, Phellandrium Aquaticum, Phytolacca Decandra, Scrophularia Nodosa, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ACONITUM NAPELLUS; BELLIS PERENNIS; BROMINE; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CONIUM MACULATUM FLOWERING TOP; IODINE; OENANTHE AQUATICA FRUIT; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: inflammation, tenderness, lumpiness, hardness, soreness, cracked or irritated nipples from nursing, shrinking breasts following nursing."
},
{
"NDCCode": "57955-0004-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0004-2)",
"NDC11Code": "57955-0004-02",
"ProductNDC": "57955-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menstrual Cramps And Irregularities",
"NonProprietaryName": "Cactus Grandiflorus, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Colocynthis, Ipecacuanha, Magnesia Phosphorica, Sepia, Viburnum Opulus, Xanthoxylum Fraxineum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "SELENICEREUS GRANDIFLORUS STEM; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; VIBURNUM OPULUS BARK; ZANTHOXYLUM AMERICANUM BARK",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: cramps, aches and pains, Abdominal bloating, heavy or gushing menstruation, backache, menstrual headache, irregular periods, lack of menstrual flow."
},
{
"NDCCode": "57955-0005-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0005-2)",
"NDC11Code": "57955-0005-02",
"ProductNDC": "57955-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferticare",
"NonProprietaryName": "Agnus Castus, Apis Mellifica, Aurum Metallicum, Borax, Conium Maculatum, Ferrum Metallicum, Iodium, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriatcum, Palladium Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CHASTE TREE; APIS MELLIFERA; GOLD; SODIUM BORATE; CONIUM MACULATUM FLOWERING TOP; IRON; IODINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PALLADIUM; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: vaginal dryness, vaginal discharge, sensitive vagina, itching of female genitals associated with sexual activities, irregular cycles and discomforts during intercourse."
},
{
"NDCCode": "57955-0008-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0008-2)",
"NDC11Code": "57955-0008-02",
"ProductNDC": "57955-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Morning Sickness",
"NonProprietaryName": "Aletris Farinosa, Amygdalus Persica, Colchicum Autumnale, Cucurbita Pepo, Semen, Ferrum Metallicum, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Tabacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALETRIS FARINOSA ROOT; PRUNUS PERSICA FLOWER; COLCHICUM AUTUMNALE BULB; PUMPKIN SEED; IRON; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOBACCO LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: morning sickness, nausea, vomiting, belching, excess saliva, sinking feeling in stomach, tiredness, weakness, sensitivity to noise, and emotional sensitivity."
},
{
"NDCCode": "57955-0010-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0010-2)",
"NDC11Code": "57955-0010-02",
"ProductNDC": "57955-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Male Strengthener",
"NonProprietaryName": "Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picnicum Acidum, Selenium Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140421",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: diminished or absent sexual desire, premature emission, weakness or pain of sexual organs, and tiredness ."
},
{
"NDCCode": "57955-0011-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0011-2)",
"NDC11Code": "57955-0011-02",
"ProductNDC": "57955-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prostate Strengthener",
"NonProprietaryName": "Baryta Carbonica, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Digitalis Purpurea, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Staphysagria, Thuja Occidentalis, Zincum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of prostate symptoms: : 1 scanty urination, 2 dribbling, 3 burning and irritation, 4 premature impotence."
},
{
"NDCCode": "57955-0012-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0012-2)",
"NDC11Code": "57955-0012-02",
"ProductNDC": "57955-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bed Wetting Prevention",
"NonProprietaryName": "Belladonna, Bellis Perennis, Benzoicum Acidum, Causticum, Equisetum Hyemale, Lycopodium Clavatum, Phosphorus, Plantago Major, Rhus Aromatica, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150831",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: involuntary urination during sleep, urinary disturbances, restless sleep.."
},
{
"NDCCode": "57955-0015-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0015-2)",
"NDC11Code": "57955-0015-02",
"ProductNDC": "57955-0015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Attention And Learning Enhancement",
"NonProprietaryName": "Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140528",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2018-02-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57955-0016-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0016-2)",
"NDC11Code": "57955-0016-02",
"ProductNDC": "57955-0016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Paraclenz",
"NonProprietaryName": "Calcarea Carbonica, Chenopodium Anthelminticum, Cina, Croton Tiglium, Filix Mas, Gambogia, Granatum, Lycopodium Clavatum, Mercurius Corrosivus, Natrum Phosphoricum, Santoninum, Senna, Spigelia Anthelmia, Stannum Metallicum, Tanacetum Vulgare, Teucrium Marum, Zingeber Officinale",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111118",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; GAMBOGE; PUNICA GRANATUM ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SANTONIN; SENNA LEAF; SPIGELIA ANTHELMIA; TIN; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptoms associated with parasites and worms: intestinal irritation, appetite swings, bad breath, constipation, itching nose or anus, angry or irritable moods."
},
{
"NDCCode": "57955-0017-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0017-2)",
"NDC11Code": "57955-0017-02",
"ProductNDC": "57955-0017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tonsilcure",
"NonProprietaryName": "Ammonium Muriaticum, Baryta Carbonica, Belladonna, Calcarea Phosphorica, Ferrum Phosphoricum, Guaiacum, Kali Muriaticum, Lycopodium Clavatum, Mercurius Solubilis, Phytolacca Decandra, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AMMONIUM CHLORIDE; BARIUM CARBONATE; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; GUAIACUM OFFICINALE RESIN; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: sore throat, inflammation, swollen glands, difficulty swallowing, associated fever, redness and burning, sensation of a lump in throat, congestion, mucous."
},
{
"NDCCode": "57955-0018-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0018-2)",
"NDC11Code": "57955-0018-02",
"ProductNDC": "57955-0018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Teething",
"NonProprietaryName": "Agaricus Muscarius, Belladonna, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Ferrum Phosphoricum, Kreosotum, Zincum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; WOOD CREOSOTE; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: teething pain, swelling gums, delayed teething, low grade fever, restlessness, heavy salivation, irritability, desire to be held constantly."
},
{
"NDCCode": "57955-0019-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0019-2)",
"NDC11Code": "57955-0019-02",
"ProductNDC": "57955-0019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Constipation Relief",
"NonProprietaryName": "Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160627",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms of constipation: irregularity, hard, dry stools, great straining, rumbling and bloated bowels, mucus in stools, associated headache."
},
{
"NDCCode": "57955-0020-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0020-2)",
"NDC11Code": "57955-0020-02",
"ProductNDC": "57955-0020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diarrhea Relief",
"NonProprietaryName": "Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Croton Tigium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms of diarrhea: loose and watery stools, cramps, gas and bloating, mucus in stools, jelly-like stool, sudden evacuation, intestinal gurgling, involuntary stools, diarrhea caused by certain foods or emotional excitement."
},
{
"NDCCode": "57955-0021-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0021-2)",
"NDC11Code": "57955-0021-02",
"ProductNDC": "57955-0021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gout Symptom Relief",
"NonProprietaryName": "Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, Urtica Urens",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR BARK; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of pain in the foot, heel, toes and joints including: swelling, burning, itching, tingling, tearing pains, throbbing, cramps, shooting pains."
},
{
"NDCCode": "57955-0022-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0022-2)",
"NDC11Code": "57955-0022-02",
"ProductNDC": "57955-0022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heartburn Relief",
"NonProprietaryName": "Abies Nigra, Arsenicum Album, Condurango, Conium Maculatum, Iris Versicolor, Magnesia Carbonica, Robinia Pseudoacacia, Sulphuricum Acidum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "PICEA MARIANA RESIN; ARSENIC TRIOXIDE; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; IRIS VERSICOLOR ROOT; MAGNESIUM CARBONATE; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptomatic relief of: acid reflux, burning pain, sour stomach, belching, indigestion, nausea, stomach spasms, stomach distention."
},
{
"NDCCode": "57955-0023-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0023-2)",
"NDC11Code": "57955-0023-02",
"ProductNDC": "57955-0023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hemorrhoid Relief",
"NonProprietaryName": "Aesculus Hippocastanum, Aloe Socotrina, Collinsonia Canadensis, Hamamelis Virginiana, Muriaticum Acidum, Nux Vomica, Paeonia Officinalis, Ratanhia, Sepia, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140604",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "HORSE CHESTNUT; ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT; SEPIA OFFICINALIS JUICE; SULFUR",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of hemorrhoid symptoms: rectal itching, backache, burning, aching or splintering pain."
}
]
}
{"NDC":[{"NDCCode":"57955-2311-2","ProprietaryName":"Calloused","NonProprietaryName":"Allium Sativum, Anacardium Orientale, Calendula Officinalis, Capsicum Annuum, Ceanothus Americanus, Chamomilla, Chelidonium Majus, Conium Maculatum, Kali Carbonicum, Lobelia Cardinalis, Mancinella, Myristica Sebifera, Pinus Sylvestris, Flos, Stigmata Maidis, Sepia, Taraxacum Officinale, Thea Sinensis"},{"NDCCode":"0548-2311-00","ProprietaryName":"Teriparatide","NonProprietaryName":"Teriparatide"},{"NDCCode":"15631-2311-2","ProprietaryName":"Cantharis","NonProprietaryName":"Cantharis"},{"NDCCode":"22840-2311-2","ProprietaryName":"Common Sagebrush","NonProprietaryName":"Artemisia Tridentata"},{"NDCCode":"36987-2311-2","ProprietaryName":"Couch Quack Grass","NonProprietaryName":"Couch Quack Grass"},{"NDCCode":"37662-2311-2","ProprietaryName":"Thiosinaminum","NonProprietaryName":"Thiosinaminum"},{"NDCCode":"55714-2311-2","ProprietaryName":"Dust - Mold - Dander","NonProprietaryName":"Felis Catus Skin, Canis Lupus Familiaris Skin, Ortcyolagus Cuniculus Skin, Equus Caballus Skin, Serinus Canaria Feather, Gallus Gallus Feather, Anas Platyrhynchos Feather, Anser Anser Feather, Melopsittacus Undulatus Feather, Phasianus Colchicus Feather, Meleagris Gallopavo Feather, Felis Catus Hair, Human Dander, Canis Lupus Familiaris Hair, Equus Caballus Hair, Oryctolagus Cuniculus Hair, Human Hair, Human Skin, Sheep Wool, Bos Taurus Hair, Capra Hircus Hair, Cavia Porcellus Hair"},{"NDCCode":"65044-2311-2","ProprietaryName":"Pollens - Weeds And Garden Plants, Ragweed. Western Ambrosia Psilostachya","NonProprietaryName":"Ragweed. Western Ambrosia Psilostachya"},{"NDCCode":"67296-2311-2","ProprietaryName":"Dicyclomine Hydrochloride","NonProprietaryName":"Dicyclomine Hydrochloride"},{"NDCCode":"71335-2311-2","ProprietaryName":"Prazosin Hydrochloride","NonProprietaryName":"Prazosin Hydrochloride"},{"NDCCode":"0480-2311-56","ProprietaryName":"Tadalafil","NonProprietaryName":"Tadalafil"},{"NDCCode":"22840-2311-4","ProprietaryName":"Common Sagebrush","NonProprietaryName":"Artemisia Tridentata"},{"NDCCode":"57955-0001-2","ProprietaryName":"Eating Disorders","NonProprietaryName":"Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album"},{"NDCCode":"57955-0002-2","ProprietaryName":"Birth Ease","NonProprietaryName":"Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus"},{"NDCCode":"57955-0003-2","ProprietaryName":"Breast Cyst And Discomforts","NonProprietaryName":"Aconitum Napellus, Bellis Perennis, Bromium, Bryonia, Chamomilla, Conium Maculatum, Iodium, Phellandrium Aquaticum, Phytolacca Decandra, Scrophularia Nodosa, Silicea"},{"NDCCode":"57955-0004-2","ProprietaryName":"Menstrual Cramps And Irregularities","NonProprietaryName":"Cactus Grandiflorus, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Colocynthis, Ipecacuanha, Magnesia Phosphorica, Sepia, Viburnum Opulus, Xanthoxylum Fraxineum"},{"NDCCode":"57955-0005-2","ProprietaryName":"Ferticare","NonProprietaryName":"Agnus Castus, Apis Mellifica, Aurum Metallicum, Borax, Conium Maculatum, Ferrum Metallicum, Iodium, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriatcum, Palladium Metallicum, Sepia"},{"NDCCode":"57955-0008-2","ProprietaryName":"Morning Sickness","NonProprietaryName":"Aletris Farinosa, Amygdalus Persica, Colchicum Autumnale, Cucurbita Pepo, Semen, Ferrum Metallicum, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Tabacum"},{"NDCCode":"57955-0010-2","ProprietaryName":"Male Strengthener","NonProprietaryName":"Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picnicum Acidum, Selenium Metallicum"},{"NDCCode":"57955-0011-2","ProprietaryName":"Prostate Strengthener","NonProprietaryName":"Baryta Carbonica, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Digitalis Purpurea, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Staphysagria, Thuja Occidentalis, Zincum Metallicum"},{"NDCCode":"57955-0012-2","ProprietaryName":"Bed Wetting Prevention","NonProprietaryName":"Belladonna, Bellis Perennis, Benzoicum Acidum, Causticum, Equisetum Hyemale, Lycopodium Clavatum, Phosphorus, Plantago Major, Rhus Aromatica, Sepia"},{"NDCCode":"57955-0015-2","ProprietaryName":"Attention And Learning Enhancement","NonProprietaryName":"Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum, Thuja Occidentalis"},{"NDCCode":"57955-0016-2","ProprietaryName":"Paraclenz","NonProprietaryName":"Calcarea Carbonica, Chenopodium Anthelminticum, Cina, Croton Tiglium, Filix Mas, Gambogia, Granatum, Lycopodium Clavatum, Mercurius Corrosivus, Natrum Phosphoricum, Santoninum, Senna, Spigelia Anthelmia, Stannum Metallicum, Tanacetum Vulgare, Teucrium Marum, Zingeber Officinale"},{"NDCCode":"57955-0017-2","ProprietaryName":"Tonsilcure","NonProprietaryName":"Ammonium Muriaticum, Baryta Carbonica, Belladonna, Calcarea Phosphorica, Ferrum Phosphoricum, Guaiacum, Kali Muriaticum, Lycopodium Clavatum, Mercurius Solubilis, Phytolacca Decandra, Silicea"},{"NDCCode":"57955-0018-2","ProprietaryName":"Teething","NonProprietaryName":"Agaricus Muscarius, Belladonna, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Ferrum Phosphoricum, Kreosotum, Zincum Metallicum"},{"NDCCode":"57955-0019-2","ProprietaryName":"Constipation Relief","NonProprietaryName":"Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia"},{"NDCCode":"57955-0020-2","ProprietaryName":"Diarrhea Relief","NonProprietaryName":"Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Croton Tigium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album"},{"NDCCode":"57955-0021-2","ProprietaryName":"Gout Symptom Relief","NonProprietaryName":"Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, Urtica Urens"},{"NDCCode":"57955-0022-2","ProprietaryName":"Heartburn Relief","NonProprietaryName":"Abies Nigra, Arsenicum Album, Condurango, Conium Maculatum, Iris Versicolor, Magnesia Carbonica, Robinia Pseudoacacia, Sulphuricum Acidum"},{"NDCCode":"57955-0023-2","ProprietaryName":"Hemorrhoid Relief","NonProprietaryName":"Aesculus Hippocastanum, Aloe Socotrina, Collinsonia Canadensis, Hamamelis Virginiana, Muriaticum Acidum, Nux Vomica, Paeonia Officinalis, Ratanhia, Sepia, Sulphur"}]}
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<NDCList>
<NDC>
<NDCCode>57955-2311-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-2311-2)</PackageDescription>
<NDC11Code>57955-2311-02</NDC11Code>
<ProductNDC>57955-2311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calloused</ProprietaryName>
<NonProprietaryName>Allium Sativum, Anacardium Orientale, Calendula Officinalis, Capsicum Annuum, Ceanothus Americanus, Chamomilla, Chelidonium Majus, Conium Maculatum, Kali Carbonicum, Lobelia Cardinalis, Mancinella, Myristica Sebifera, Pinus Sylvestris, Flos, Stigmata Maidis, Sepia, Taraxacum Officinale, Thea Sinensis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>GARLIC; SEMECARPUS ANACARDIUM JUICE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; CEANOTHUS AMERICANUS LEAF; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; POTASSIUM CARBONATE; LOBELIA CARDINALIS; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; VIROLA SEBIFERA RESIN; PINUS SYLVESTRIS FLOWERING TOP; CORN SILK; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; GREEN TEA LEAF</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: hard-heartedness, fear of losing control. indifference, coldness toward others.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0548-2311-00</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0548-2311-00) / 2.24 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00548-2311-00</NDC11Code>
<ProductNDC>0548-2311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriparatide</ProprietaryName>
<NonProprietaryName>Teriparatide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20251222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213641</ApplicationNumber>
<LabelerName>Amphastar Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TERIPARATIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriparatide injection is indicated: 1 For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Teriparatide injection reduces the risk of vertebral and nonvertebral fractures., 2 To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy., 3 For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.</IndicationAndUsage>
<Description>Teriparatide injection is a synthetic parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide is C181H291N55O51S2 and molecular weight is 4117.8 daltons. Its amino acid sequence is shown below. Teriparatide is manufactured using synthetic technology. Teriparatide injection is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each delivery device (pen) is filled with volume to allow delivery of 2.24 mL. Each mL contains 250 mcg of teriparatide (as a free base), 0.41 mg of glacial acetic acid, 0.1 mg of sodium acetate (anhydrous), 45.4 mg of mannitol, 3 mg of Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the pH to 4. Each prefilled delivery device (pen) delivers 20 mcg of teriparatide per dose for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times.</Description>
</NDC>
<NDC>
<NDCCode>15631-2311-2</NDCCode>
<PackageDescription>1 CONTAINER in 1 CONTAINER (15631-2311-2) > 200 g in 1 CONTAINER</PackageDescription>
<NDC11Code>15631-2311-02</NDC11Code>
<ProductNDC>15631-2311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cantharis</ProprietaryName>
<NonProprietaryName>Cantharis</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160330</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>LYTTA VESICATORIA</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>22840-2311-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-2311-2) </PackageDescription>
<NDC11Code>22840-2311-02</NDC11Code>
<ProductNDC>22840-2311</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Common Sagebrush</ProprietaryName>
<NonProprietaryName>Artemisia Tridentata</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>ARTEMISIA TRIDENTATA POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</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>36987-2311-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2311-2)</PackageDescription>
<NDC11Code>36987-2311-02</NDC11Code>
<ProductNDC>36987-2311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Couch Quack Grass</ProprietaryName>
<NonProprietaryName>Couch Quack Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ELYMUS REPENS POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-2311-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-2311-2) </PackageDescription>
<NDC11Code>37662-2311-02</NDC11Code>
<ProductNDC>37662-2311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thiosinaminum</ProprietaryName>
<NonProprietaryName>Thiosinaminum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230111</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>ALLYLTHIOUREA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55714-2311-2</NDCCode>
<PackageDescription>57 g in 1 BOTTLE, GLASS (55714-2311-2)</PackageDescription>
<NDC11Code>55714-2311-02</NDC11Code>
<ProductNDC>55714-2311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dust - Mold - Dander</ProprietaryName>
<NonProprietaryName>Felis Catus Skin, Canis Lupus Familiaris Skin, Ortcyolagus Cuniculus Skin, Equus Caballus Skin, Serinus Canaria Feather, Gallus Gallus Feather, Anas Platyrhynchos Feather, Anser Anser Feather, Melopsittacus Undulatus Feather, Phasianus Colchicus Feather, Meleagris Gallopavo Feather, Felis Catus Hair, Human Dander, Canis Lupus Familiaris Hair, Equus Caballus Hair, Oryctolagus Cuniculus Hair, Human Hair, Human Skin, Sheep Wool, Bos Taurus Hair, Capra Hircus Hair, Cavia Porcellus Hair</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>FELIS CATUS SKIN; CANIS LUPUS FAMILIARIS SKIN; ORYCTOLAGUS CUNICULUS SKIN; EQUUS CABALLUS SKIN; SERINUS CANARIA FEATHER; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; MELOPSITTACUS UNDULATUS FEATHER; PHASIANUS COLCHICUS FEATHER; MELEAGRIS GALLOPAVO FEATHER; FELIS CATUS HAIR; HUMAN DANDER; CANIS LUPUS FAMILIARIS HAIR; EQUUS CABALLUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; HUMAN HAIR; HUMAN SKIN; SHEEP WOOL; BOS TAURUS HAIR; CAPRA HIRCUS HAIR; CAVIA PORCELLUS HAIR; MESOCRICETUS AURATUS HAIR; WHEAT GLUTEN; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM HERBARUM; HOUSE DUST; CANDIDA ALBICANS; HISTAMINE DIHYDROCHLORIDE; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BLATTA ORIENTALIS; BROMINE; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Formulated for associated symptoms such as labored breathing, congestion, sneezing, runny nose, watery eyes and skin irritations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65044-2311-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-2311-2) </PackageDescription>
<NDC11Code>65044-2311-02</NDC11Code>
<ProductNDC>65044-2311</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Pollens - Weeds And Garden Plants, Ragweed. Western Ambrosia Psilostachya</ProprietaryName>
<NonProprietaryName>Ragweed. Western Ambrosia Psilostachya</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19410419</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103888</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>AMBROSIA PSILOSTACHYA POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19410419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for: 1 Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.</IndicationAndUsage>
<Description>Non-standardized allergenic extracts are labeled “No U.S. Standard of Potency”. Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative. Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution. Product concentrations vary based on the source. Refer to the vial label for the product concentration. Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents: casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements. Acetone and ether may be used as drying and de-fatting agents. Candida albicans cells are treated with phenol, which is removed by dialysis. Dog Hair and Dander extracts are manufactured in 3 product forms: 1 Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas., 2 Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas., 3 Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas.</Description>
</NDC>
<NDC>
<NDCCode>67296-2311-2</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (67296-2311-2) </PackageDescription>
<NDC11Code>67296-2311-02</NDC11Code>
<ProductNDC>67296-2311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240507</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217566</ApplicationNumber>
<LabelerName>Redpharm Drug</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride tablets are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride tablets USP, is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form. Dicyclomine hydrochloride tablets USP, for oral use contain 20 mg dicyclomine hydrochloride USP. Dicyclomine hydrochloride 20 mg tablets also contain inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue #1, hypromellose, lactose monohydrate, sodium starch glycolate, and stearic acid. Dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid,2-(diethylamino) ethyl ester, hydrochloride with a molecular formula of C 19H 35NO 2HCl and the following structural formula:. Dicyclomine hydrochloride occurs as a fine, white, crystalline powder. It is soluble in water, freely soluble in alcohol and in chloroform and very slightly soluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>71335-2311-2</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (71335-2311-2) </PackageDescription>
<NDC11Code>71335-2311-02</NDC11Code>
<ProductNDC>71335-2311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215697</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride USP, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular Formula: C19H21N5O4HCl. It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>0480-2311-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-2311-56) </PackageDescription>
<NDC11Code>00480-2311-56</NDC11Code>
<ProductNDC>0480-2311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240116</StartMarketingDate>
<EndMarketingDate>20260831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205885</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240116</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
<Description>Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as oval-shaped film-coated tablets for oral administration. Each tablet contains 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sodium lauryl sulfate. The film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, talc, titanium dioxide, triacetin, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>22840-2311-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-2311-4) </PackageDescription>
<NDC11Code>22840-2311-04</NDC11Code>
<ProductNDC>22840-2311</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Common Sagebrush</ProprietaryName>
<NonProprietaryName>Artemisia Tridentata</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>ARTEMISIA TRIDENTATA POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</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>57955-0001-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0001-2)</PackageDescription>
<NDC11Code>57955-0001-02</NDC11Code>
<ProductNDC>57955-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eating Disorders</ProprietaryName>
<NonProprietaryName>Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; CINCHONA OFFICINALIS BARK; IRON; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for a natural aid for relief of: nausea, vomiting, loss of appetite, digestive tract disturbances and emotional sensitivity that may be associated with eating disorders.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0002-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0002-2)</PackageDescription>
<NDC11Code>57955-0002-02</NDC11Code>
<ProductNDC>57955-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Birth Ease</ProprietaryName>
<NonProprietaryName>Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: Muscular pains, stinging pain, tenderness over abdomen, vaginal dryness and heat, tender nipples, spasmodic labor pains, restlessness, extreme backache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0003-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0003-2)</PackageDescription>
<NDC11Code>57955-0003-02</NDC11Code>
<ProductNDC>57955-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Breast Cyst And Discomforts</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Bellis Perennis, Bromium, Bryonia, Chamomilla, Conium Maculatum, Iodium, Phellandrium Aquaticum, Phytolacca Decandra, Scrophularia Nodosa, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; BELLIS PERENNIS; BROMINE; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CONIUM MACULATUM FLOWERING TOP; IODINE; OENANTHE AQUATICA FRUIT; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: inflammation, tenderness, lumpiness, hardness, soreness, cracked or irritated nipples from nursing, shrinking breasts following nursing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0004-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0004-2)</PackageDescription>
<NDC11Code>57955-0004-02</NDC11Code>
<ProductNDC>57955-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menstrual Cramps And Irregularities</ProprietaryName>
<NonProprietaryName>Cactus Grandiflorus, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Colocynthis, Ipecacuanha, Magnesia Phosphorica, Sepia, Viburnum Opulus, Xanthoxylum Fraxineum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>SELENICEREUS GRANDIFLORUS STEM; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; VIBURNUM OPULUS BARK; ZANTHOXYLUM AMERICANUM BARK</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: cramps, aches and pains, Abdominal bloating, heavy or gushing menstruation, backache, menstrual headache, irregular periods, lack of menstrual flow.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0005-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0005-2)</PackageDescription>
<NDC11Code>57955-0005-02</NDC11Code>
<ProductNDC>57955-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferticare</ProprietaryName>
<NonProprietaryName>Agnus Castus, Apis Mellifica, Aurum Metallicum, Borax, Conium Maculatum, Ferrum Metallicum, Iodium, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriatcum, Palladium Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CHASTE TREE; APIS MELLIFERA; GOLD; SODIUM BORATE; CONIUM MACULATUM FLOWERING TOP; IRON; IODINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PALLADIUM; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: vaginal dryness, vaginal discharge, sensitive vagina, itching of female genitals associated with sexual activities, irregular cycles and discomforts during intercourse.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0008-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0008-2)</PackageDescription>
<NDC11Code>57955-0008-02</NDC11Code>
<ProductNDC>57955-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Morning Sickness</ProprietaryName>
<NonProprietaryName>Aletris Farinosa, Amygdalus Persica, Colchicum Autumnale, Cucurbita Pepo, Semen, Ferrum Metallicum, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Tabacum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALETRIS FARINOSA ROOT; PRUNUS PERSICA FLOWER; COLCHICUM AUTUMNALE BULB; PUMPKIN SEED; IRON; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOBACCO LEAF</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: morning sickness, nausea, vomiting, belching, excess saliva, sinking feeling in stomach, tiredness, weakness, sensitivity to noise, and emotional sensitivity.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0010-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0010-2)</PackageDescription>
<NDC11Code>57955-0010-02</NDC11Code>
<ProductNDC>57955-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Male Strengthener</ProprietaryName>
<NonProprietaryName>Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picnicum Acidum, Selenium Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140421</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: diminished or absent sexual desire, premature emission, weakness or pain of sexual organs, and tiredness .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0011-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0011-2)</PackageDescription>
<NDC11Code>57955-0011-02</NDC11Code>
<ProductNDC>57955-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prostate Strengthener</ProprietaryName>
<NonProprietaryName>Baryta Carbonica, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Digitalis Purpurea, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Staphysagria, Thuja Occidentalis, Zincum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140331</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of prostate symptoms: : 1 scanty urination, 2 dribbling, 3 burning and irritation, 4 premature impotence.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0012-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0012-2)</PackageDescription>
<NDC11Code>57955-0012-02</NDC11Code>
<ProductNDC>57955-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bed Wetting Prevention</ProprietaryName>
<NonProprietaryName>Belladonna, Bellis Perennis, Benzoicum Acidum, Causticum, Equisetum Hyemale, Lycopodium Clavatum, Phosphorus, Plantago Major, Rhus Aromatica, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150831</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: involuntary urination during sleep, urinary disturbances, restless sleep..</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0015-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0015-2)</PackageDescription>
<NDC11Code>57955-0015-02</NDC11Code>
<ProductNDC>57955-0015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Attention And Learning Enhancement</ProprietaryName>
<NonProprietaryName>Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140528</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-02-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57955-0016-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0016-2)</PackageDescription>
<NDC11Code>57955-0016-02</NDC11Code>
<ProductNDC>57955-0016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Paraclenz</ProprietaryName>
<NonProprietaryName>Calcarea Carbonica, Chenopodium Anthelminticum, Cina, Croton Tiglium, Filix Mas, Gambogia, Granatum, Lycopodium Clavatum, Mercurius Corrosivus, Natrum Phosphoricum, Santoninum, Senna, Spigelia Anthelmia, Stannum Metallicum, Tanacetum Vulgare, Teucrium Marum, Zingeber Officinale</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111118</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; GAMBOGE; PUNICA GRANATUM ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SANTONIN; SENNA LEAF; SPIGELIA ANTHELMIA; TIN; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptoms associated with parasites and worms: intestinal irritation, appetite swings, bad breath, constipation, itching nose or anus, angry or irritable moods.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0017-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0017-2)</PackageDescription>
<NDC11Code>57955-0017-02</NDC11Code>
<ProductNDC>57955-0017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tonsilcure</ProprietaryName>
<NonProprietaryName>Ammonium Muriaticum, Baryta Carbonica, Belladonna, Calcarea Phosphorica, Ferrum Phosphoricum, Guaiacum, Kali Muriaticum, Lycopodium Clavatum, Mercurius Solubilis, Phytolacca Decandra, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AMMONIUM CHLORIDE; BARIUM CARBONATE; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; GUAIACUM OFFICINALE RESIN; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: sore throat, inflammation, swollen glands, difficulty swallowing, associated fever, redness and burning, sensation of a lump in throat, congestion, mucous.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0018-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0018-2)</PackageDescription>
<NDC11Code>57955-0018-02</NDC11Code>
<ProductNDC>57955-0018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Teething</ProprietaryName>
<NonProprietaryName>Agaricus Muscarius, Belladonna, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Ferrum Phosphoricum, Kreosotum, Zincum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; WOOD CREOSOTE; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: teething pain, swelling gums, delayed teething, low grade fever, restlessness, heavy salivation, irritability, desire to be held constantly.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0019-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0019-2)</PackageDescription>
<NDC11Code>57955-0019-02</NDC11Code>
<ProductNDC>57955-0019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Constipation Relief</ProprietaryName>
<NonProprietaryName>Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160627</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms of constipation: irregularity, hard, dry stools, great straining, rumbling and bloated bowels, mucus in stools, associated headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0020-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0020-2)</PackageDescription>
<NDC11Code>57955-0020-02</NDC11Code>
<ProductNDC>57955-0020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diarrhea Relief</ProprietaryName>
<NonProprietaryName>Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Croton Tigium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms of diarrhea: loose and watery stools, cramps, gas and bloating, mucus in stools, jelly-like stool, sudden evacuation, intestinal gurgling, involuntary stools, diarrhea caused by certain foods or emotional excitement.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0021-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0021-2)</PackageDescription>
<NDC11Code>57955-0021-02</NDC11Code>
<ProductNDC>57955-0021</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gout Symptom Relief</ProprietaryName>
<NonProprietaryName>Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, Urtica Urens</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR BARK; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of pain in the foot, heel, toes and joints including: swelling, burning, itching, tingling, tearing pains, throbbing, cramps, shooting pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0022-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0022-2)</PackageDescription>
<NDC11Code>57955-0022-02</NDC11Code>
<ProductNDC>57955-0022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heartburn Relief</ProprietaryName>
<NonProprietaryName>Abies Nigra, Arsenicum Album, Condurango, Conium Maculatum, Iris Versicolor, Magnesia Carbonica, Robinia Pseudoacacia, Sulphuricum Acidum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>PICEA MARIANA RESIN; ARSENIC TRIOXIDE; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; IRIS VERSICOLOR ROOT; MAGNESIUM CARBONATE; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptomatic relief of: acid reflux, burning pain, sour stomach, belching, indigestion, nausea, stomach spasms, stomach distention.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0023-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0023-2)</PackageDescription>
<NDC11Code>57955-0023-02</NDC11Code>
<ProductNDC>57955-0023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hemorrhoid Relief</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Aloe Socotrina, Collinsonia Canadensis, Hamamelis Virginiana, Muriaticum Acidum, Nux Vomica, Paeonia Officinalis, Ratanhia, Sepia, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140604</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>HORSE CHESTNUT; ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT; SEPIA OFFICINALIS JUICE; SULFUR</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of hemorrhoid symptoms: rectal itching, backache, burning, aching or splintering pain.</IndicationAndUsage>
</NDC>
</NDCList>