{
"NDC": [
{
"NDCCode": "61727-326-21",
"PackageDescription": "4 g in 1 TUBE (61727-326-21) ",
"NDC11Code": "61727-0326-21",
"ProductNDC": "61727-326",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eczema Relief",
"NonProprietaryName": "Antimony Trisulfide, Apis Mellifera, Arsenic Trioxide, Atropa Belladonna, Graphite, Arctium Lappa Fruit, Kerosene, Solidago Canadensis Whole, Viola Tricolor",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120706",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; GRAPHITE; ARCTIUM LAPPA FRUIT; KEROSENE; SOLIDAGO CANADENSIS WHOLE; VIOLA TRICOLOR",
"StrengthNumber": "5; 5; 5; 5; 5; 4; 5; 4; 4",
"StrengthUnit": "[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2019-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120706",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "16590-326-21",
"PackageDescription": "21 TABLET in 1 BOTTLE, PLASTIC (16590-326-21)",
"NDC11Code": "16590-0326-21",
"ProductNDC": "16590-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19740226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083677",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions: 1 Endocrine disordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer , 2 Rheumatic disordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis , 3 Collagen diseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis , 4 Dermatologic diseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis , 5 Allergic statesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisSerum sicknessBronchial asthmaContact dermatitisAtopic dermatitisDrug hypersensitivity reactions , 6 Ophthalmic diseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia , 7 Respiratory diseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis , 8 Hematologic disordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia , 9 Neoplastic diseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood , 10 Edematous statesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus , 11 Gastrointestinal diseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 Nervous SystemAcute exacerbations of multiple sclerosis , 13 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The molecular formula for prednisone is C21H26O5. Chemically, it is 17, 21-dihydroxypregna-1, 4-diene-3,11,20-trione and has the following structural formula. Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.44. It melts at about 230°C with some decomposition. Prednisone is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 1 mg, 2.5 mg, 5 mg, 10 mg, or 20 mg of prednisone. Inactive ingredients:1 mg: anhydrous lactose, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.|2.5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.10 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.20 mg: anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "55513-326-21",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (55513-326-21) / 50 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55513-0326-21",
"ProductNDC": "55513-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Riabni",
"NonProprietaryName": "Rituximab-arrx",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210106",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761140",
"LabelerName": "Amgen, Inc",
"SubstanceName": "RITUXIMAB",
"StrengthNumber": "500",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250721",
"SamplePackage": "N",
"IndicationAndUsage": "RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).",
"Description": "Rituximab-arrx is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-arrx has an approximate molecular weight of 145 kD. Rituximab-arrx is produced in a mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RIABNI (rituximab-arrx) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous infusion. RIABNI is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-arrx, polysorbate 80 (0.7 mg), sodium chloride (9 mg), sodium citrate dihydrate (7.35 mg), and Water for Injection, USP. Hydrochloric acid is used to adjust the buffer solution pH. The pH is 6.5."
},
{
"NDCCode": "57237-326-21",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (57237-326-21) / 6 SUPPOSITORY in 1 BLISTER PACK (57237-326-16) ",
"NDC11Code": "57237-0326-21",
"ProductNDC": "57237-326",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Glycerin",
"ProprietaryNameSuffix": "Children",
"NonProprietaryName": "Glycerin",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20230824",
"EndMarketingDate": "20261130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007.54",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "GLYCERIN",
"StrengthNumber": "1.2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230824",
"EndMarketingDatePackage": "20261130",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 for relief of occasional constipation, 2 this product usually produces bowel movement in 1/4 to 1 hour."
},
{
"NDCCode": "61919-326-21",
"PackageDescription": "21 TABLET in 1 BOTTLE (61919-326-21) ",
"NDC11Code": "61919-0326-21",
"ProductNDC": "61919-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080356",
"LabelerName": "Direct_Rx",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190918",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic diseases: pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory diseases: symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Nervous system: acute exacerbations of multiple sclerosis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C21H26O5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone Tablets USP 20 mg also contain FD&C Yellow No. 6."
},
{
"NDCCode": "63323-326-20",
"PackageDescription": "10 VIAL in 1 CARTON (63323-326-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-326-21) ",
"NDC11Code": "63323-0326-20",
"ProductNDC": "63323-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefepime",
"NonProprietaryName": "Cefepime",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20100830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065441",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "CEFEPIME HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2023-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100830",
"SamplePackage": "N",
"IndicationAndUsage": "Cefepime for injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms: 1 Pneumonia. ( 1.1) , 2 Empiric therapy for febrile neutropenic patients. ( 1.2) , 3 Uncomplicated and complicated urinary tract infections (including pyelonephritis). ( 1.3) , 4 Uncomplicated skin and skin structure infections. ( 1.4) , 5 Complicated intra-abdominal infections (used in combination with metronidazole) in adults. ( 1.5) .",
"Description": "Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinum chloride,7 2-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula:. Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19H 24N 6O 5S 2) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber."
},
{
"NDCCode": "61727-301-21",
"PackageDescription": "4 g in 1 TUBE (61727-301-21) ",
"NDC11Code": "61727-0301-21",
"ProductNDC": "61727-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Onion, Apis Mellifera, Drosera Rotundifolia, Euphrasia Stricta, Urtica Urens",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120608",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "ONION; APIS MELLIFERA; DROSERA ROTUNDIFOLIA; EUPHRASIA STRICTA; URTICA URENS",
"StrengthNumber": "8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120608",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to."
},
{
"NDCCode": "61727-302-21",
"PackageDescription": "4 g in 1 TUBE (61727-302-21) ",
"NDC11Code": "61727-0302-21",
"ProductNDC": "61727-302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthritis Relief",
"NonProprietaryName": "Arnica Montana, Bryonia Alba, Chamomilla,hypericum Perforatum, Kalmia Latifolia Leaf,kalmia Latifolia Leaf",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120731",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "ARNICA MONTANA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "18; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120731",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-303-21",
"PackageDescription": "4 g in 1 TUBE (61727-303-21) ",
"NDC11Code": "61727-0303-21",
"ProductNDC": "61727-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu Relief",
"NonProprietaryName": "Aconitum Napellus, Onion, Arnica Montana, Atropa Belladonna, Solanum Dulcamara Top, Eupatorium Cannabinum, Gelsemium Sempervirens Root",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120705",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; EUPATORIUM CANNABINUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ONION; SOLANUM DULCAMARA TOP",
"StrengthNumber": "14; 8; 8; 8; 18; 8; 8",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120705",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-304-21",
"PackageDescription": "4 g in 1 TUBE (61727-304-21) ",
"NDC11Code": "61727-0304-21",
"ProductNDC": "61727-304",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Constipation Relief",
"NonProprietaryName": "Aluminum Oxide, Bryonia Alba Root, Sodium Chloride, Graphite, Silicon Dioxide",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120705",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "ALUMINUM OXIDE; BRYONIA ALBA ROOT; SODIUM CHLORIDE; GRAPHITE; SILICON DIOXIDE",
"StrengthNumber": "10; 8; 8; 10; 10",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120705",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-305-21",
"PackageDescription": "4 g in 1 TUBE (61727-305-21) ",
"NDC11Code": "61727-0305-21",
"ProductNDC": "61727-305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Headache Relief",
"NonProprietaryName": "Atropa Belladonna, Cyclamen Purpurascens Tuber, Coffea Arabica Seed, Roasted, Iris Versicolor Root, Strychnos Nux-vomica Seed, Sanguinaria Canadensis Root, Spigelia Marilandica Root, Viburnum Opulus Bark",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120720",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "ATROPA BELLADONNA; CYCLAMEN PURPURASCENS TUBER; COFFEA ARABICA SEED, ROASTED; IRIS VERSICOLOR ROOT; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SPIGELIA MARILANDICA ROOT; VIBURNUM OPULUS BARK",
"StrengthNumber": "8; 8; 4; 8; 9; 8; 8; 4",
"StrengthUnit": "[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Turn turn upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-306-21",
"PackageDescription": "4 g in 1 TUBE (61727-306-21) ",
"NDC11Code": "61727-0306-21",
"ProductNDC": "61727-306",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hemorrhoids Relief",
"NonProprietaryName": "Horse Chestnut,aloe,hamamelis Virginiana Root Bark/stem Bark,nitric Acid,paeonia Officinalis Root,sepia Officinalis Juice.",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "HORSE CHESTNUT; ALOE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; NITRIC ACID; PAEONIA OFFICINALIS ROOT; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
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"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-307-21",
"PackageDescription": "4 g in 1 TUBE (61727-307-21) ",
"NDC11Code": "61727-0307-21",
"ProductNDC": "61727-307",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Insomnia Relief",
"NonProprietaryName": "Insomnia Relief",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120720",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; DATURA STRAMONIUM; STRYCHNOS NUX-VOMICA SEED",
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"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]",
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"StartMarketingDatePackage": "20120720",
"SamplePackage": "N",
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},
{
"NDCCode": "61727-308-21",
"PackageDescription": "4 g in 1 TUBE (61727-308-21) ",
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"ProductNDC": "61727-308",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menopause Relief",
"NonProprietaryName": "Barium Carbonate, Atropa Belladonna, Black Cohosh, Nitroglycerin, Lachesis Muta Venom, Silicon Dioxide",
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"StartMarketingDate": "20120723",
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"LabelerName": "Homeocare Laboratories",
"SubstanceName": "BARIUM CARBONATE; ATROPA BELLADONNA; BLACK COHOSH; NITROGLYCERIN; LACHESIS MUTA VENOM; SILICON DIOXIDE",
"StrengthNumber": "10; 8; 8; 8; 10; 10",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20120723",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of hot flashes, mood swings, depression and fatigue associated with hormonal changes."
},
{
"NDCCode": "61727-309-21",
"PackageDescription": "4 g in 1 TUBE (61727-309-21) ",
"NDC11Code": "61727-0309-21",
"ProductNDC": "61727-309",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Muscular Pain Relief",
"NonProprietaryName": "Arnica Montana, Copper, Potassium Phosphate, Dibasic, Lactic Acid, Dl-,magnesium Phosphate, Dibasic Trihydrate",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120723",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "ARNICA MONTANA; COPPER; POTASSIUM PHOSPHATE, DIBASIC; LACTIC ACID, DL-; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
"StrengthNumber": "18; 10; 8; 8; 10",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20120723",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-310-21",
"PackageDescription": "4 g in 1 TUBE (61727-310-21) ",
"NDC11Code": "61727-0310-21",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pms Relief",
"NonProprietaryName": "Copper, Estrone, Histamine Dihydrochloride, Magnesium Phosphate, Tribasic, Pentahydrate, Sodium Sulfate",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120723",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "COPPER; ESTRONE; HISTAMINE DIHYDROCHLORIDE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; SODIUM SULFATE",
"StrengthNumber": "10; 18; 8; 10; 8",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
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"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-311-21",
"PackageDescription": "4 g in 1 TUBE (61727-311-21) ",
"NDC11Code": "61727-0311-21",
"ProductNDC": "61727-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sore Throat Relief",
"NonProprietaryName": "Aconitum Napellus,apis Mellifera,atropa Belladonna,solanum Dulcamara Top,mercurius Solubilis,phytolacca Americana Root.",
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"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; SOLANUM DULCAMARA TOP; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT",
"StrengthNumber": "10; 10; 10; 8; 10; 8",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2019-02-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-312-21",
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"NDC11Code": "61727-0312-21",
"ProductNDC": "61727-312",
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"DosageFormName": "PELLET",
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"StartMarketingDate": "20120803",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "SILVER NITRATE; MATRICARIA RECUTITA; COFFEA ARABICA SEED, ROASTED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; DATURA STRAMONIUM",
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"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
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"LastUpdate": "2020-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20120803",
"SamplePackage": "N"
},
{
"NDCCode": "61727-315-21",
"PackageDescription": "4 g in 1 TUBE (61727-315-21) ",
"NDC11Code": "61727-0315-21",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tinnitus Relief",
"NonProprietaryName": "Cinchona Officinalis Bark,salicylic Acid,quinine Sulfate,ferrum Phosphoricum,potassium Chloride,calomel,allylthiourea,.",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "CINCHONA OFFICINALIS BARK; SALICYLIC ACID; QUININE SULFATE; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE; CALOMEL; ALLYLTHIOUREA",
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"StrengthUnit": "[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g",
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"Status": "Active",
"LastUpdate": "2019-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-316-21",
"PackageDescription": "4 g in 1 TUBE (61727-316-21) ",
"NDC11Code": "61727-0316-21",
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"DosageFormName": "PELLET",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "AVENA SATIVA FLOWERING TOP; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SILICON DIOXIDE; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TURNERA DIFFUSA LEAFY TWIG",
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"StrengthUnit": "[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120814",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-317-21",
"PackageDescription": "4 g in 1 TUBE (61727-317-21) ",
"NDC11Code": "61727-0317-21",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vigofem Plus For Women",
"NonProprietaryName": "Chaste Tree, Barium Carbonate, Conium Maculatum Flowering Top, Phosphoric Acid, Sepia Officinalis Juice",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "CHASTE TREE; BARIUM CARBONATE; CONIUM MACULATUM FLOWERING TOP; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE",
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"StrengthUnit": "[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g",
"Status": "Deprecated",
"LastUpdate": "2020-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N"
},
{
"NDCCode": "61727-318-21",
"PackageDescription": "4 g in 1 TUBE (61727-318-21) ",
"NDC11Code": "61727-0318-21",
"ProductNDC": "61727-318",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blatrol Bladder Relief",
"NonProprietaryName": "Lytta Vesicatoria, Causticum, Equisetum Hyemale, Chondrodendron Tomentosum Root, Saw Palmetto, Sepia Officinalis Juice, Delphinium Staphisagria Seed",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120618",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
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"LastUpdate": "2019-03-13",
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"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-319-21",
"PackageDescription": "4 g in 1 TUBE (61727-319-21) ",
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"NonProprietaryName": "Cadmium Sulfate, Graphite, Phosphoric Acid, Silicon Dioxide, Selenium, Thallium, Ustilago Maydis",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
"SubstanceName": "CADMIUM SULFATE; GRAPHITE; PHOSPHORIC ACID; SILICON DIOXIDE; SELENIUM; THALLIUM; USTILAGO MAYDIS",
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"LastUpdate": "2019-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-320-21",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motion Sickness Relief",
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"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120723",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
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"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
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"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."
},
{
"NDCCode": "61727-321-21",
"PackageDescription": "4 g in 1 TUBE (61727-321-21) ",
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"ProductNDC": "61727-321",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fibromyalgia Relief",
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"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120709",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Homeocare Laboratories",
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"Status": "Deprecated",
"LastUpdate": "2020-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20120709",
"SamplePackage": "N"
},
{
"NDCCode": "61727-322-21",
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"ProductNDC": "61727-322",
"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120720",
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},
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},
{
"NDCCode": "61727-327-21",
"PackageDescription": "4 g in 1 TUBE (61727-327-21) ",
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<PackageDescription>4 g in 1 TUBE (61727-326-21) </PackageDescription>
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<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120706</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; GRAPHITE; ARCTIUM LAPPA FRUIT; KEROSENE; SOLIDAGO CANADENSIS WHOLE; VIOLA TRICOLOR</SubstanceName>
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<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-07</LastUpdate>
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<NDC>
<NDCCode>16590-326-21</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE, PLASTIC (16590-326-21)</PackageDescription>
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<NonProprietaryName>Prednisone</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19740226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083677</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2018-02-07</LastUpdate>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions: 1 Endocrine disordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer , 2 Rheumatic disordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis , 3 Collagen diseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis , 4 Dermatologic diseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis , 5 Allergic statesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisSerum sicknessBronchial asthmaContact dermatitisAtopic dermatitisDrug hypersensitivity reactions , 6 Ophthalmic diseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia , 7 Respiratory diseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis , 8 Hematologic disordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia , 9 Neoplastic diseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood , 10 Edematous statesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus , 11 Gastrointestinal diseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 Nervous SystemAcute exacerbations of multiple sclerosis , 13 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The molecular formula for prednisone is C21H26O5. Chemically, it is 17, 21-dihydroxypregna-1, 4-diene-3,11,20-trione and has the following structural formula. Prednisone is a white to practically white, odorless, crystalline powder and has a molecular weight of 358.44. It melts at about 230°C with some decomposition. Prednisone is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 1 mg, 2.5 mg, 5 mg, 10 mg, or 20 mg of prednisone. Inactive ingredients:1 mg: anhydrous lactose, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.|2.5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.5 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.10 mg: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc.20 mg: anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
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<NDCCode>55513-326-21</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (55513-326-21) / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55513-0326-21</NDC11Code>
<ProductNDC>55513-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Riabni</ProprietaryName>
<NonProprietaryName>Rituximab-arrx</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210106</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761140</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>RITUXIMAB</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).</IndicationAndUsage>
<Description>Rituximab-arrx is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-arrx has an approximate molecular weight of 145 kD. Rituximab-arrx is produced in a mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RIABNI (rituximab-arrx) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous infusion. RIABNI is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-arrx, polysorbate 80 (0.7 mg), sodium chloride (9 mg), sodium citrate dihydrate (7.35 mg), and Water for Injection, USP. Hydrochloric acid is used to adjust the buffer solution pH. The pH is 6.5.</Description>
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<PackageDescription>2 BLISTER PACK in 1 CARTON (57237-326-21) / 6 SUPPOSITORY in 1 BLISTER PACK (57237-326-16) </PackageDescription>
<NDC11Code>57237-0326-21</NDC11Code>
<ProductNDC>57237-326</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Glycerin</ProprietaryName>
<ProprietaryNameSuffix>Children</ProprietaryNameSuffix>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20230824</StartMarketingDate>
<EndMarketingDate>20261130</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007.54</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>GLYCERIN</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230824</StartMarketingDatePackage>
<EndMarketingDatePackage>20261130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 for relief of occasional constipation, 2 this product usually produces bowel movement in 1/4 to 1 hour.</IndicationAndUsage>
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<NDC>
<NDCCode>61919-326-21</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE (61919-326-21) </PackageDescription>
<NDC11Code>61919-0326-21</NDC11Code>
<ProductNDC>61919-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080356</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic diseases: pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory diseases: symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Nervous system: acute exacerbations of multiple sclerosis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below. C21H26O5 M.W. 358.44. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone Tablets USP 20 mg also contain FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>63323-326-20</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (63323-326-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-326-21) </PackageDescription>
<NDC11Code>63323-0326-20</NDC11Code>
<ProductNDC>63323-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefepime</ProprietaryName>
<NonProprietaryName>Cefepime</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20100830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065441</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>CEFEPIME HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefepime for injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms: 1 Pneumonia. ( 1.1) , 2 Empiric therapy for febrile neutropenic patients. ( 1.2) , 3 Uncomplicated and complicated urinary tract infections (including pyelonephritis). ( 1.3) , 4 Uncomplicated skin and skin structure infections. ( 1.4) , 5 Complicated intra-abdominal infections (used in combination with metronidazole) in adults. ( 1.5) .</IndicationAndUsage>
<Description>Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinum chloride,7 2-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula:. Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19H 24N 6O 5S 2) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber.</Description>
</NDC>
<NDC>
<NDCCode>61727-301-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-301-21) </PackageDescription>
<NDC11Code>61727-0301-21</NDC11Code>
<ProductNDC>61727-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Onion, Apis Mellifera, Drosera Rotundifolia, Euphrasia Stricta, Urtica Urens</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120608</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ONION; APIS MELLIFERA; DROSERA ROTUNDIFOLIA; EUPHRASIA STRICTA; URTICA URENS</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-302-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-302-21) </PackageDescription>
<NDC11Code>61727-0302-21</NDC11Code>
<ProductNDC>61727-302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthritis Relief</ProprietaryName>
<NonProprietaryName>Arnica Montana, Bryonia Alba, Chamomilla,hypericum Perforatum, Kalmia Latifolia Leaf,kalmia Latifolia Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120731</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ARNICA MONTANA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>18; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-303-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-303-21) </PackageDescription>
<NDC11Code>61727-0303-21</NDC11Code>
<ProductNDC>61727-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu Relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Onion, Arnica Montana, Atropa Belladonna, Solanum Dulcamara Top, Eupatorium Cannabinum, Gelsemium Sempervirens Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120705</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; EUPATORIUM CANNABINUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ONION; SOLANUM DULCAMARA TOP</SubstanceName>
<StrengthNumber>14; 8; 8; 8; 18; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-304-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-304-21) </PackageDescription>
<NDC11Code>61727-0304-21</NDC11Code>
<ProductNDC>61727-304</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Constipation Relief</ProprietaryName>
<NonProprietaryName>Aluminum Oxide, Bryonia Alba Root, Sodium Chloride, Graphite, Silicon Dioxide</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120705</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ALUMINUM OXIDE; BRYONIA ALBA ROOT; SODIUM CHLORIDE; GRAPHITE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>10; 8; 8; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-305-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-305-21) </PackageDescription>
<NDC11Code>61727-0305-21</NDC11Code>
<ProductNDC>61727-305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Headache Relief</ProprietaryName>
<NonProprietaryName>Atropa Belladonna, Cyclamen Purpurascens Tuber, Coffea Arabica Seed, Roasted, Iris Versicolor Root, Strychnos Nux-vomica Seed, Sanguinaria Canadensis Root, Spigelia Marilandica Root, Viburnum Opulus Bark</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120720</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ATROPA BELLADONNA; CYCLAMEN PURPURASCENS TUBER; COFFEA ARABICA SEED, ROASTED; IRIS VERSICOLOR ROOT; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SPIGELIA MARILANDICA ROOT; VIBURNUM OPULUS BARK</SubstanceName>
<StrengthNumber>8; 8; 4; 8; 9; 8; 8; 4</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn turn upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-306-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-306-21) </PackageDescription>
<NDC11Code>61727-0306-21</NDC11Code>
<ProductNDC>61727-306</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hemorrhoids Relief</ProprietaryName>
<NonProprietaryName>Horse Chestnut,aloe,hamamelis Virginiana Root Bark/stem Bark,nitric Acid,paeonia Officinalis Root,sepia Officinalis Juice.</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120720</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>HORSE CHESTNUT; ALOE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; NITRIC ACID; PAEONIA OFFICINALIS ROOT; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-307-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-307-21) </PackageDescription>
<NDC11Code>61727-0307-21</NDC11Code>
<ProductNDC>61727-307</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Insomnia Relief</ProprietaryName>
<NonProprietaryName>Insomnia Relief</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120720</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; DATURA STRAMONIUM; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>3; 14; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times/day & at bedtime or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-308-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-308-21) </PackageDescription>
<NDC11Code>61727-0308-21</NDC11Code>
<ProductNDC>61727-308</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menopause Relief</ProprietaryName>
<NonProprietaryName>Barium Carbonate, Atropa Belladonna, Black Cohosh, Nitroglycerin, Lachesis Muta Venom, Silicon Dioxide</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>BARIUM CARBONATE; ATROPA BELLADONNA; BLACK COHOSH; NITROGLYCERIN; LACHESIS MUTA VENOM; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>10; 8; 8; 8; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of hot flashes, mood swings, depression and fatigue associated with hormonal changes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-309-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-309-21) </PackageDescription>
<NDC11Code>61727-0309-21</NDC11Code>
<ProductNDC>61727-309</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Muscular Pain Relief</ProprietaryName>
<NonProprietaryName>Arnica Montana, Copper, Potassium Phosphate, Dibasic, Lactic Acid, Dl-,magnesium Phosphate, Dibasic Trihydrate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ARNICA MONTANA; COPPER; POTASSIUM PHOSPHATE, DIBASIC; LACTIC ACID, DL-; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE</SubstanceName>
<StrengthNumber>18; 10; 8; 8; 10</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-310-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-310-21) </PackageDescription>
<NDC11Code>61727-0310-21</NDC11Code>
<ProductNDC>61727-310</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pms Relief</ProprietaryName>
<NonProprietaryName>Copper, Estrone, Histamine Dihydrochloride, Magnesium Phosphate, Tribasic, Pentahydrate, Sodium Sulfate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>COPPER; ESTRONE; HISTAMINE DIHYDROCHLORIDE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; SODIUM SULFATE</SubstanceName>
<StrengthNumber>10; 18; 8; 10; 8</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-311-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-311-21) </PackageDescription>
<NDC11Code>61727-0311-21</NDC11Code>
<ProductNDC>61727-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sore Throat Relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus,apis Mellifera,atropa Belladonna,solanum Dulcamara Top,mercurius Solubilis,phytolacca Americana Root.</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; SOLANUM DULCAMARA TOP; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 8; 10; 8</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-02-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-312-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-312-21) </PackageDescription>
<NDC11Code>61727-0312-21</NDC11Code>
<ProductNDC>61727-312</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stress Relief</ProprietaryName>
<NonProprietaryName>Silver Nitrate,matricaria Recutita,coffea Arabica Seed, Roasted,strychnos Ignatii Seed,strychnos Nux-vomica Seed,phosphoric Acid,datura Stramonium.</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120803</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>SILVER NITRATE; MATRICARIA RECUTITA; COFFEA ARABICA SEED, ROASTED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; DATURA STRAMONIUM</SubstanceName>
<StrengthNumber>10; 8; 8; 10; 10; 8; 10</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61727-315-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-315-21) </PackageDescription>
<NDC11Code>61727-0315-21</NDC11Code>
<ProductNDC>61727-315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tinnitus Relief</ProprietaryName>
<NonProprietaryName>Cinchona Officinalis Bark,salicylic Acid,quinine Sulfate,ferrum Phosphoricum,potassium Chloride,calomel,allylthiourea,.</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>CINCHONA OFFICINALIS BARK; SALICYLIC ACID; QUININE SULFATE; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE; CALOMEL; ALLYLTHIOUREA</SubstanceName>
<StrengthNumber>9; 15; 9; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-316-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-316-21) </PackageDescription>
<NDC11Code>61727-0316-21</NDC11Code>
<ProductNDC>61727-316</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vigoril Plus</ProprietaryName>
<NonProprietaryName>Silver Nitrate, Avena Sativa Flowering Top, Potassium Phosphate, Dibasic, Strychnos Nux-vomica Seed, Phosphoric Acid, Silicon Dioxide, Turnera Diffusa Leafy Twig</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120814</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>AVENA SATIVA FLOWERING TOP; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SILICON DIOXIDE; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TURNERA DIFFUSA LEAFY TWIG</SubstanceName>
<StrengthNumber>9; 7; 7; 5; 5; 9; 12</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-317-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-317-21) </PackageDescription>
<NDC11Code>61727-0317-21</NDC11Code>
<ProductNDC>61727-317</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vigofem Plus For Women</ProprietaryName>
<NonProprietaryName>Chaste Tree, Barium Carbonate, Conium Maculatum Flowering Top, Phosphoric Acid, Sepia Officinalis Juice</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>CHASTE TREE; BARIUM CARBONATE; CONIUM MACULATUM FLOWERING TOP; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>12; 7; 4; 9; 9</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61727-318-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-318-21) </PackageDescription>
<NDC11Code>61727-0318-21</NDC11Code>
<ProductNDC>61727-318</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blatrol Bladder Relief</ProprietaryName>
<NonProprietaryName>Lytta Vesicatoria, Causticum, Equisetum Hyemale, Chondrodendron Tomentosum Root, Saw Palmetto, Sepia Officinalis Juice, Delphinium Staphisagria Seed</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120618</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>LYTTA VESICATORIA; CAUSTICUM; EQUISETUM HYEMALE; CHONDRODENDRON TOMENTOSUM ROOT; SAW PALMETTO; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED</SubstanceName>
<StrengthNumber>6; 5; 6; 5; 5; 5; 5</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-319-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-319-21) </PackageDescription>
<NDC11Code>61727-0319-21</NDC11Code>
<ProductNDC>61727-319</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hair-x Hair Loss Relief</ProprietaryName>
<NonProprietaryName>Cadmium Sulfate, Graphite, Phosphoric Acid, Silicon Dioxide, Selenium, Thallium, Ustilago Maydis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120710</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>CADMIUM SULFATE; GRAPHITE; PHOSPHORIC ACID; SILICON DIOXIDE; SELENIUM; THALLIUM; USTILAGO MAYDIS</SubstanceName>
<StrengthNumber>12; 4; 5; 4; 5; 7; 9</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-320-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-320-21) </PackageDescription>
<NDC11Code>61727-0320-21</NDC11Code>
<ProductNDC>61727-320</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motion Sickness Relief</ProprietaryName>
<NonProprietaryName>Arnica Montana, Atropa Belladonna, Anamirta Cocculus Seed, Laburnum Anagyroides Flowering Top, Liquid Petroleum, Mandragora Officinarum Root, Tobacco Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ANAMIRTA COCCULUS SEED; ARNICA MONTANA; ATROPA BELLADONNA; LABURNUM ANAGYROIDES FLOWERING TOP; LIQUID PETROLEUM; MANDRAGORA OFFICINARUM ROOT; TOBACCO LEAF</SubstanceName>
<StrengthNumber>9; 9; 30; 7; 9; 9; 12</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-321-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-321-21) </PackageDescription>
<NDC11Code>61727-0321-21</NDC11Code>
<ProductNDC>61727-321</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fibromyalgia Relief</ProprietaryName>
<NonProprietaryName>Arnica Montana, Lactic Acid, Strychnos Nux-vomica Seed, Potassium Phosphate, Dibasic, Cupric Arsenite</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120709</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ARNICA MONTANA; LACTIC ACID; STRYCHNOS NUX-VOMICA SEED; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; CUPRIC ARSENITE</SubstanceName>
<StrengthNumber>18; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61727-322-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-322-21) </PackageDescription>
<NDC11Code>61727-0322-21</NDC11Code>
<ProductNDC>61727-322</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibs Relief</ProprietaryName>
<NonProprietaryName>Citrullus Colocynthis Fruit Pulp,gratiola Officinalis,lycopodium Clavatum Spore,sodium Carbonate,strychnos Nux-vomica Seed,sulfur,taxus Baccata Fruit,podophyllum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120720</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>CITRULLUS COLOCYNTHIS FRUIT PULP; GRATIOLA OFFICINALIS; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SULFUR; TAXUS BACCATA FRUIT; PODOPHYLLUM</SubstanceName>
<StrengthNumber>7; 5; 5; 5; 9; 5; 5; 4</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61727-323-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-323-21) </PackageDescription>
<NDC11Code>61727-0323-21</NDC11Code>
<ProductNDC>61727-323</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sciatica Relief</ProprietaryName>
<NonProprietaryName>Arnica Montana Flower, Bryonia Alba Whole, Matricaria Recutita, Pseudognaphalium Luteoalbum Leaf, Kalmia Latifolia Leaf, Toxicodendron Pubescens Leaf, Viscum Album Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ARNICA MONTANA FLOWER; BRYONIA ALBA WHOLE; MATRICARIA RECUTITA; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM LEAF</SubstanceName>
<StrengthNumber>9; 4; 200; 5; 4; 4; 4; 6</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under our tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellet with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-324-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-324-21) </PackageDescription>
<NDC11Code>61727-0324-21</NDC11Code>
<ProductNDC>61727-324</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ez-quit</ProprietaryName>
<NonProprietaryName>Antimony Trisulfide, Dieffenbachia Seguine, Strychnos Ignatii Seed, Lobelia Inflata, Tobacco Leaf</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; DIEFFENBACHIA SEGUINE; STRYCHNOS IGNATII SEED; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF</SubstanceName>
<StrengthNumber>5; 5; 5; 5; 5; 9</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-325-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-325-21) </PackageDescription>
<NDC11Code>61727-0325-21</NDC11Code>
<ProductNDC>61727-325</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ez-slim</ProprietaryName>
<NonProprietaryName>Antimony Trisulfide,semecarpus Anacardium Juice,fucus Vesiculosus,bos Taurus Hypothalamus,sodium Sulfate,phytolacca Americana Root,thyroid, Unspecified.</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120706</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; SEMECARPUS ANACARDIUM JUICE; FUCUS VESICULOSUS; BOS TAURUS HYPOTHALAMUS; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; THYROID, UNSPECIFIED</SubstanceName>
<StrengthNumber>5; 5; 1; 18; 9; 2; 8</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2019-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61727-327-21</NDCCode>
<PackageDescription>4 g in 1 TUBE (61727-327-21) </PackageDescription>
<NDC11Code>61727-0327-21</NDC11Code>
<ProductNDC>61727-327</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hbp Relief</ProprietaryName>
<NonProprietaryName>Barium Carbonate,atropa Belladonna,nitroglycerin,lycopus Virginicus,strychnos Nux-vomica Seed,lead.</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120710</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Homeocare Laboratories</LabelerName>
<SubstanceName>BARIUM CARBONATE; ATROPA BELLADONNA; NITROGLYCERIN; LYCOPUS VIRGINICUS; STRYCHNOS NUX-VOMICA SEED; LEAD</SubstanceName>
<StrengthNumber>4; 4; 4; 6; 4; 4</StrengthNumber>
<StrengthUnit>[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>