{
"NDC": [
{
"NDCCode": "66096-727-05",
"PackageDescription": "59 mL in 1 BOTTLE, GLASS (66096-727-05) ",
"NDC11Code": "66096-0727-05",
"ProductNDC": "66096-727",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Sleep Well",
"NonProprietaryName": "Avena Sativa, Coffea Cruda, Ignatia Amara, Nux Vomica, Passiflora, Incarnata, Stramonium, Valeriana Officinalis.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170421",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; DATURA STRAMONIUM; VALERIAN",
"StrengthNumber": "4; 30; 12; 30; 4; 30; 4",
"StrengthUnit": "[hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170421",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves sleeplessness and simple insomnia due to restless mind and nightmares.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "42543-727-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (42543-727-05)",
"NDC11Code": "42543-0727-05",
"ProductNDC": "42543-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204597",
"LabelerName": "Vensun Pharmaceuticals, Inc.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2017-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150316",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine is indicated for the treatment of. Fluoxetine and Olanzapine in Combination is indicated for the treatment of. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water.Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch (maize [corn]), colloidal silicon dioxide, gelatin, sodium lauryl sulphate, FD&C Blue #1, FD&C Red #3, and titanium dioxide. In addition, 20 mg capsules also contains D&C Yellow #10 and 10 mg capsules also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "42806-727-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-727-05) ",
"NDC11Code": "42806-0727-05",
"ProductNDC": "42806-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213854",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. ( 1.3) .",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol Succinate Extended-Release Tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropyl amino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethyl ether and heptane. Inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose, hypromellose, lactose monohydrate (25 mg and 50 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, sugar spheres (composed of corn starch and sucrose), talc, titanium dioxide and triethyl citrate. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "55111-727-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-727-05) ",
"NDC11Code": "55111-0727-05",
"ProductNDC": "55111-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is:. Ropinirole hydrochloride USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "67777-727-05",
"PackageDescription": "4 BOX in 1 CASE (67777-727-05) / 6 TUBE in 1 BOX (67777-727-04) / 113 g in 1 TUBE (67777-727-03) ",
"NDC11Code": "67777-0727-05",
"ProductNDC": "67777-727",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antifungal",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260324",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Dynarex Corporation",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260324",
"SamplePackage": "N",
"IndicationAndUsage": " For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). Relieves itching, scaling, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch and itching, burning feet."
},
{
"NDCCode": "68462-727-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68462-727-05) ",
"NDC11Code": "68462-0727-05",
"ProductNDC": "68462-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saxagliptin",
"NonProprietaryName": "Saxagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205994",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "SAXAGLIPTIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230731",
"SamplePackage": "N",
"Description": "Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to off-white powder. It is soluble in methanol, ethanol; sparingly soluble in water. Each film-coated tablet of saxagliptin for oral use contains either 2.79 mg saxagliptin hydrochloride equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: hypromellose, iron oxide yellow (2.5 mg tablet only), iron oxide red (5 mg tablet only), polyethylene glycol and titanium dioxide. The imprinting ink contains the following: ammonium hydroxide, n-butyl alcohol, FD&C blue #2, isopropyl alcohol, propylene glycol and shellac."
},
{
"NDCCode": "76420-727-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (76420-727-05) ",
"NDC11Code": "76420-0727-05",
"ProductNDC": "76420-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200562",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240510",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. It has the following chemical structure. C 17H 14F 3N 3O 2S M.W. 381.38. Celecoxib, USP is a white to almost white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib, USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: black iron oxide, crospovidone, dehydrated alcohol, FD&C Blue No.1, gelatin, lactose monohydrate, magnesium stearate, povidone, shellac, sodium lauryl sulfate, and titanium dioxide. The 50 mg, 200 mg and 400 mg capsules also contain D&C Yellow No. 10. The 50 mg, 100 mg and 200 mg capsules also contain D&C Red No. 28. The 400 mg capsule also contains FD&C Yellow No. 6."
},
{
"NDCCode": "66096-113-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-113-05)",
"NDC11Code": "66096-0113-05",
"ProductNDC": "66096-113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anxiety/stress Relief",
"NonProprietaryName": "Argentum Nitricum, Aurum Metallicum, Avena Sativa, Gelsemium Sempervirens, Hyoscyamus Niger, Ignatia Amara, Moschus, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS WHOLE; SODIUM CHLORIDE; PASSIFLORA INCARNATA TOP; TIN; VALERIAN",
"StrengthNumber": "8; 13; 2; 13; 13; 13; 13; 13; 2; 13; 2",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "66096-114-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-114-05) ",
"NDC11Code": "66096-0114-05",
"ProductNDC": "66096-114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold",
"NonProprietaryName": "Aconitum Napellus, Bryonia Alba, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Kali Bichromicum, Kali Lodatum, Zincum Gluconicum.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; ZINC GLUCONATE",
"StrengthNumber": "4; 6; 4; 4; 6; 6; 6; 3",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170109",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms caused by the common cold.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-115-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-115-05) ",
"NDC11Code": "66096-0115-05",
"ProductNDC": "66096-115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough Relief",
"NonProprietaryName": "Aconitum Nap, Antimon Crud, Antimon Sulph, Antimon Tart, Aralia Rac, Bryonia, Chelidonium Maj, Cuprum Met, Drosera, Hepar Sulph Calc, Kali Carb, Spongia.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150521",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ANTIMONY PENTASULFIDE; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COPPER; DROSERA ROTUNDIFOLIA; CALCIUM SULFIDE; POTASSIUM CARBONATE; SPONGIA OFFICINALIS SKELETON, ROASTED",
"StrengthNumber": "6; 8; 8; 8; 4; 6; 6; 12; 6; 12; 12; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150521",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves cough symptoms of diverse origins. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-119-05",
"PackageDescription": "59 mL in 1 BOTTLE, GLASS (66096-119-05) ",
"NDC11Code": "66096-0119-05",
"ProductNDC": "66096-119",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Immune Complex",
"NonProprietaryName": "Adrenal Gland, Echinacea Angustifolia, Ferrum Phosphoricum, Kali Muriaticum, Liver Extractum, Pituitarum Posterium, Placenta Totalis Suis, Viscum Album.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; MAMMAL LIVER; SUS SCROFA PITUITARY GLAND, POSTERIOR; SUS SCROFA PLACENTA; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "8; 3; 6; 4; 8; 8; 8; 3",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Temporarily relieves general immune system disorders.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "66096-120-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-120-05) ",
"NDC11Code": "66096-0120-05",
"ProductNDC": "66096-120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Fatigue Relief",
"NonProprietaryName": "Aceticum Ac, Adrenal Gland, Arnica, Benzoicum Ac, Ferrum Phos, Fluoricum Ac, Ginseng, Kali Carb, Kali Lod, Kali Mur, Kali Phos, Lacticum Ac, Phosphoricum Ac, Picricum Ac.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150521",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ACETIC ACID; BOS TAURUS ADRENAL GLAND; ARNICA MONTANA; BENZOIC ACID; FERROSOFERRIC PHOSPHATE; HYDROFLUORIC ACID; ASIAN GINSENG; POTASSIUM CARBONATE; POTASSIUM IODIDE; POTASSIUM CHLORIDE; DIBASIC POTASSIUM PHOSPHATE; LACTIC ACID, DL-; PHOSPHORIC ACID; PICRIC ACID",
"StrengthNumber": "30; 10; 12; 30; 6; 30; 3; 4; 3; 3; 3; 30; 30; 30",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nitrogen Binding Agent [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150521",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves general weakness. Improves stamina.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-121-05",
"PackageDescription": "59 mL in 1 PACKAGE (66096-121-05) ",
"NDC11Code": "66096-0121-05",
"ProductNDC": "66096-121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Fever Relief",
"NonProprietaryName": "Aconitum Nap, Baptisia, Belladonna, Bryonia, Chamomilla, Eupatorium Perf, Gelsemium, Rhus Tox.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120607",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ACONITUM NAPELLUS; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA CHAMOMILLA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 24; 6; 6; 4; 6; 5; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120607",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves fever symptoms, helps the body fight viral and bacterial infections.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "66096-122-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-122-05) ",
"NDC11Code": "66096-0122-05",
"ProductNDC": "66096-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ohm Pituitarum Complex",
"NonProprietaryName": "Adrenal Gland, Adrenocorticotrophin, Cerebrum, Liver Gland, Pituitarum Posterium Gland, Placenta, Thyroidinum.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170410",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "EPINEPHRINE; CORTICOTROPIN; SUS SCROFA CEREBRUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND, POSTERIOR; SUS SCROFA PLACENTA; THYROID, UNSPECIFIED",
"StrengthNumber": "10; 10; 14; 10; 10; 8; 8",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170410",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves endocrine system imbalance (glands - hormones).**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-125-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-125-05) ",
"NDC11Code": "66096-0125-05",
"ProductNDC": "66096-125",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Control",
"NonProprietaryName": "Aceticum Ac, Anacard Or, Baryta Iod, Calc Carb, Capsicum, Fucus, Graphites,, Nat Sulphuricum, Phytolacca, Stannum Met, Thyroidinum, Zinc Met.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130930",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ACETIC ACID; SEMECARPUS ANACARDIUM JUICE; BARIUM IODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; FUCUS VESICULOSUS; GRAPHITE; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; TIN; THYROID, UNSPECIFIED; ZINC",
"StrengthNumber": "10; 14; 12; 14; 14; 5; 14; 14; 7; 16; 12; 14",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130930",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves food cravings. Helps control appetite and balance metabolism to reduce weight gain. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-153-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-153-05) ",
"NDC11Code": "66096-0153-05",
"ProductNDC": "66096-153",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Pancreas Aid",
"NonProprietaryName": "Helonias Dioica, Lacticum Acidum, Pancreas Suis, Pancreatinum, Phosphoricum Acidum, Phosphorus, Syzygium Jambolanum, Thyroidinum, Uranium Nitricum.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150803",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "CHAMAELIRIUM LUTEUM ROOT; LACTIC ACID, DL-; SUS SCROFA PANCREAS; PANCRELIPASE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; THYROID, UNSPECIFIED; URANYL NITRATE HEXAHYDRATE",
"StrengthNumber": "30; 4; 8; 14; 10; 10; 3; 8; 12",
"StrengthUnit": "[hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150803",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves metabolic pancreas dysfunctions.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "66096-154-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-154-05) ",
"NDC11Code": "66096-0154-05",
"ProductNDC": "66096-154",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Sore Throat",
"NonProprietaryName": "Aconitum Nap, Ailanthus, Baptisia, Belladonna, Ferrum Phos, Hepar Sulph Calc, Hydrastis, Merc Cyan, Merc Iod Rub, Phytolacca.",
"DosageFormName": "SPRAY",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20170410",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ACONITUM NAPELLUS; AILANTHUS ALTISSIMA FLOWERING TWIG; BAPTISIA TINCTORIA; ATROPA BELLADONNA; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; GOLDENSEAL; MERCURIC CYANIDE; MERCURIC IODIDE; PHYTOLACCA AMERICANA ROOT",
"StrengthNumber": "7; 16; 3; 7; 6; 12; 3; 16; 8; 3",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170410",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms caused by common throat irritation.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-156-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-156-05) ",
"NDC11Code": "66096-0156-05",
"ProductNDC": "66096-156",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Menopause",
"NonProprietaryName": "Ammonium Carbonicum, Amyl Nitrosum, Cimicifuga Racemosa, Glonoinum, Lachesis Mutus, Sanguinaria, Canadensis.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "AMMONIUM CARBONATE; AMYL NITRITE; BLACK COHOSH; NITROGLYCERIN; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT",
"StrengthNumber": "12; 6; 3; 12; 12; 4",
"StrengthUnit": "[hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150819",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms caused by common menopause, hormonal imbalances. ** This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-157-05",
"PackageDescription": "59 mL in 1 BOTTLE, GLASS (66096-157-05) ",
"NDC11Code": "66096-0157-05",
"ProductNDC": "66096-157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ohm Parasites",
"NonProprietaryName": "Chenopodium Anthelminticum, Cina, Cucurbita, Pepo, Cuprum Oxydatum Nigrum, Filix Mas, Granatum, Kousso, Ratanhia, Santoninum, Sabadilla, Spigelia, Teucrium Marum.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; PUMPKIN SEED; CUPRIC OXIDE; DRYOPTERIS FILIX-MAS ROOT; PUNICA GRANATUM ROOT BARK; HAGENIA ABYSSINICA FLOWER; KRAMERIA LAPPACEA ROOT; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SPIGELIA MARILANDICA ROOT; TEUCRIUM MARUM",
"StrengthNumber": "6; 6; 3; 12; 4; 4; 7; 4; 10; 4; 4; 4",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150819",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms caused by parasites and worms such as bloating, itching and intestinal dysfunction.**. ** This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-158-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-158-05)",
"NDC11Code": "66096-0158-05",
"ProductNDC": "66096-158",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Allium Cepa, Apis Mellifica, Aralia Racemosa, Blatta Orientalis, Euphrasia Officinalis, Galphimia Glauca, Hedera Helix, Luffa Operculata, Okoubaka, Sabadilla.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20150417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; BLATTA ORIENTALIS; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; LUFFA OPERCULATA FRUIT; OKOUBAKA AUBREVILLEI BARK; SCHOENOCAULON OFFICINALE SEED",
"StrengthNumber": "5; 5; 5; 5; 5; 5; 5; 5; 5; 5",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "USES: Temporarily relieves respiratory symptoms caused by common allergens."
},
{
"NDCCode": "66096-159-05",
"PackageDescription": "59 mL in 1 BOTTLE, GLASS (66096-159-05) ",
"NDC11Code": "66096-0159-05",
"ProductNDC": "66096-159",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ohm Mouthwash",
"NonProprietaryName": "Arnica Montana, Borax, Calendula Officinalis, Hypericum Perforatum, Myrrha, Plantago Major, Ratanhia, Salvia Officinalis, Symphytum Officinale.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ARNICA MONTANA; SODIUM BORATE; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; MYRRH; PLANTAGO MAJOR; KRAMERIA LAPPACEA ROOT; SAGE; COMFREY ROOT",
"StrengthNumber": "3; 3; 1; 3; 3; 1; 3; 1; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150915",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves sensitive, bleeding gums and gingivitis.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-168-05",
"PackageDescription": "59 mL in 1 PACKAGE (66096-168-05) ",
"NDC11Code": "66096-0168-05",
"ProductNDC": "66096-168",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acne Relief",
"NonProprietaryName": "Antimonium Crud, Arsenicum Brom, Bovista, Eugenia Jamb, Fluoricum Acidum, Hepar Sulph Calc, Kali Brom, Kali Iod, Kali Mur, Nat Brom, Niccolum Sulph, Phosphoricum Ac, Sulphur Iod.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150521",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ANTIMONY TRISULFIDE; ARSENIC TRIBROMIDE; LYCOPERDON UTRIFORME FRUITING BODY; SYZYGIUM JAMBOS SEED; HYDROFLUORIC ACID; CALCIUM SULFIDE; POTASSIUM BROMIDE; POTASSIUM IODIDE; POTASSIUM CHLORIDE; SODIUM BROMIDE; NICKEL SULFATE HEXAHYDRATE; PHOSPHORIC ACID; SULFUR IODIDE",
"StrengthNumber": "6; 30; 30; 14; 30; 30; 3; 3; 6; 4; 4; 30; 14",
"StrengthUnit": "[hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150521",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves pustular eruptions, acne simplex and indurate. Helps prevent recurrence of bluish red and acne eruptions.**."
},
{
"NDCCode": "66096-191-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-191-05) ",
"NDC11Code": "66096-0191-05",
"ProductNDC": "66096-191",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Cholesterol Aid",
"NonProprietaryName": "Cholesterinum, Fel Tauri, Guatteria Guameri.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "CHOLESTEROL; BOS TAURUS BILE; MALMEA DEPRESSA BARK",
"StrengthNumber": "13; 3; 5",
"StrengthUnit": "[hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170110",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves ailments related with slow hepatic metabolism resulting in elevated cholesterol levels.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-192-05",
"PackageDescription": "59 mL in 1 PACKAGE (66096-192-05) ",
"NDC11Code": "66096-0192-05",
"ProductNDC": "66096-192",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eczema Relief",
"NonProprietaryName": "Arsenicum Iodatum, Kali Bromatum, Kali Muriaticum, Natrum Bromatum, Niccolum Sulphuricum, Sulphur Iodatum, Viola Tricolor, Zincum Bromatum.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150522",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ARSENIC TRIIODIDE; POTASSIUM BROMIDE; POTASSIUM CHLORIDE; SODIUM BROMIDE; NICKEL SULFATE HEXAHYDRATE; SULFUR IODIDE; VIOLA TRICOLOR; ZINC BROMIDE",
"StrengthNumber": "8; 4; 4; 4; 5; 14; 12; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150522",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves eczema - psoriatic skin symptoms.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-669-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-669-05) ",
"NDC11Code": "66096-0669-05",
"ProductNDC": "66096-669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Allergy Animal Mix",
"NonProprietaryName": "Cat Hair, Cattle, Dog, Guinea Pig, Hamster, Hog, Mouse, Rabbit Hair And Epithelia, Chicken, Duck, Goose Feathers, Horse Hair And Dander, Histaminum.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130313",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "FELIS CATUS HAIR; BOS TAURUS HAIR; CANIS LUPUS FAMILIARIS HAIR; CAVIA PORCELLUS HAIR; MESOCRICETUS AURATUS SKIN; SUS SCROFA HAIR; MUS MUSCULUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; ORYCTOLAGUS CUNICULUS SKIN; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; EQUUS CABALLUS HAIR; EQUUS CABALLUS DANDER; HISTAMINE DIHYDROCHLORIDE",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 60",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; 1/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Cells, Epidermal [EXT], Cells, Epidermal [EXT], Dander [CS], Dander [CS], Feathers [CS], Feathers [CS], Feathers [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Animal Dander Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Skin Allergenic Extract [EPC], Non-Standardized Animal Skin Allergenic Extract [EPC], Non-Standardized Feather Allergenic Extract [EPC], Non-Standardized Feather Allergenic Extract [EPC], Non-Standardized Feather Allergenic Extract [EPC], Salivary Proteins and Peptides [CS], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130313",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves allergy symptoms associated with exposure to hair, feathers, dander, and/or epithelia from animals.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "66096-670-05",
"PackageDescription": "59 mL in 1 PACKAGE (66096-670-05) ",
"NDC11Code": "66096-0670-05",
"ProductNDC": "66096-670",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Allergy Mold Mix",
"NonProprietaryName": "Alternaria Alt, Aspergillus Fum, Aspergillus Nig, Boletus Sat, Botrytis Cin, Candida Alb, Cladosporium Met, Fusarium Oxy, Helminthosporium, Murcor Mue, Pullularia Pul, Rhizopus Nig, Ustaligo, Histaminum.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20151029",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; BOLETUS SATANAS FRUITING BODY; BOTRYTIS CINEREA; CANDIDA ALBICANS; PASSALORA FULVA; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; USTILAGO MAYDIS; HISTAMINE DIHYDROCHLORIDE",
"StrengthNumber": "14; 14; 14; 14; 14; 14; 14; 14; 14; 14; 14; 14; 60",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151029",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves sneezing, runny nose, itchy eyes associated with exposure to molds and fungi.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "66096-671-05",
"PackageDescription": "59 mL in 1 BOTTLE, GLASS (66096-671-05) ",
"NDC11Code": "66096-0671-05",
"ProductNDC": "66096-671",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Allergy Grass, Weed, Tree Mix",
"NonProprietaryName": "Bermuda, Birch Mix, Brome, Carduus Marianus, Chelidonium Majus, Common Mugwort, English Plantain, Goldenrod, Hydrastis Canadensis, Histam, Johnson, Kentucky, Maple Mix, Nasturtium Aqua, Oak Mix, Orchard, Pigweed Mix, Pine Mix, Ragweed Mix, Red Cedar, Red Mulb, Scrophularia Nod, Sheep Sorrel, Soildago Virg, Sweet Vernal, Taraxacum Offi, Timothy, White Poplar.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130313",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ACER PSEUDOPLATANUS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA VULGARIS POLLEN; BETULA PENDULA WHOLE; BROMUS SECALINUS TOP; CHELIDONIUM MAJUS; CYNODON DACTYLON; DACTYLIS GLOMERATA POLLEN; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA POLLEN; MILK THISTLE; MORUS RUBRA POLLEN; NASTURTIUM OFFICINALE; PHLEUM PRATENSE POLLEN; PINUS MASSONIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; QUERCUS SPP. WHOLE; RUMEX ACETOSELLA POLLEN; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; SOLIDAGO VIRGAUREA POLLEN; SORGHUM HALEPENSE POLLEN; TARAXACUM OFFICINALE POLLEN",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 3; 6; 6; 5; 60; 6; 3; 6; 3; 6; 6; 6; 6; 6; 6; 6; 3; 3; 6; 6; 3",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130313",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves sneezing, runny nose, itchy eyes and congestion associated with exposure to grasses, weeds and trees. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-672-05",
"PackageDescription": "60 mL in 1 BOTTLE, GLASS (66096-672-05) ",
"NDC11Code": "66096-0672-05",
"ProductNDC": "66096-672",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vida Hair Oil",
"NonProprietaryName": "Arnica Montana.",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170102",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/60mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170102",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Temporarily relieves excessive hair loss.**. **The uses for our products are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "66096-710-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-710-05) ",
"NDC11Code": "66096-0710-05",
"ProductNDC": "66096-710",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Allium Cepa, Apis Mellifica, Aralia Racemosa, Blatta Orientalis, Bovista, Carduus Marianus, Chelidonium Majus, Euphrasia Officinalas, Galphimia Glauca, Hedera Helix, Hydrastis Canadensis, Luffa Operculata, Nasturtium Aquaticum, Okoubaka, Sabadilla, Scrophularia Nodosa, Solidago Virgaurea, Taraxacum Officinale.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; BLATTA ORIENTALIS; LYCOPERDON UTRIFORME FRUITING BODY; MILK THISTLE; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; GOLDENSEAL; LUFFA OPERCULATA FRUIT; NASTURTIUM OFFICINALE; OKOUBAKA AUBREVILLEI BARK; SCHOENOCAULON OFFICINALE SEED; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE",
"StrengthNumber": "5; 5; 5; 12; 12; 3; 3; 8; 5; 5; 5; 5; 3; 5; 5; 3; 5; 3",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170602",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves coryza, cough and itchy eyes symptoms associated with hay fever and common allergens.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-713-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-713-05) ",
"NDC11Code": "66096-0713-05",
"ProductNDC": "66096-713",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anxiety Stress Relief",
"NonProprietaryName": "Arg Nit, Aur Met, Avena, Gelsemium, Hyoscyamus, Ignatia, Moschus, Nat Mur, Passiflora, Stannum Met, Valeriana.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS WHOLE; SODIUM CHLORIDE; PASSIFLORA INCARNATA TOP; TIN; VALERIAN",
"StrengthNumber": "8; 13; 2; 13; 13; 13; 13; 13; 2; 13; 2",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves anxiety, irritability and nervousness due to every day stress.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
}
]
}
{"NDC":[{"NDCCode":"66096-727-05","ProprietaryName":"Ohm Sleep Well","NonProprietaryName":"Avena Sativa, Coffea Cruda, Ignatia Amara, Nux Vomica, Passiflora, Incarnata, Stramonium, Valeriana Officinalis."},{"NDCCode":"42543-727-05","ProprietaryName":"Fluoxetine","NonProprietaryName":"Fluoxetine Hydrochloride"},{"NDCCode":"42806-727-05","ProprietaryName":"Metoprolol Succinate","NonProprietaryName":"Metoprolol Succinate"},{"NDCCode":"55111-727-05","ProprietaryName":"Ropinirole","NonProprietaryName":"Ropinirole"},{"NDCCode":"67777-727-05","ProprietaryName":"Antifungal","NonProprietaryName":"Clotrimazole"},{"NDCCode":"68462-727-05","ProprietaryName":"Saxagliptin","NonProprietaryName":"Saxagliptin"},{"NDCCode":"76420-727-05","ProprietaryName":"Celecoxib","NonProprietaryName":"Celecoxib"},{"NDCCode":"66096-113-05","ProprietaryName":"Anxiety/stress Relief","NonProprietaryName":"Argentum Nitricum, Aurum Metallicum, Avena Sativa, Gelsemium Sempervirens, Hyoscyamus Niger, Ignatia Amara, Moschus, 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<NDC11Code>66096-0727-05</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Sleep Well</ProprietaryName>
<NonProprietaryName>Avena Sativa, Coffea Cruda, Ignatia Amara, Nux Vomica, Passiflora, Incarnata, Stramonium, Valeriana Officinalis.</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20170421</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; DATURA STRAMONIUM; VALERIAN</SubstanceName>
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<StrengthUnit>[hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL</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>
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<LastUpdate>2021-12-31</LastUpdate>
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<IndicationAndUsage>USES: Temporarily relieves sleeplessness and simple insomnia due to restless mind and nightmares.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
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<NDC>
<NDCCode>42543-727-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (42543-727-05)</PackageDescription>
<NDC11Code>42543-0727-05</NDC11Code>
<ProductNDC>42543-727</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204597</ApplicationNumber>
<LabelerName>Vensun Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-11-01</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Fluoxetine is indicated for the treatment of. Fluoxetine and Olanzapine in Combination is indicated for the treatment of. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water.Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch (maize [corn]), colloidal silicon dioxide, gelatin, sodium lauryl sulphate, FD&C Blue #1, FD&C Red #3, and titanium dioxide. In addition, 20 mg capsules also contains D&C Yellow #10 and 10 mg capsules also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<NDC>
<NDCCode>42806-727-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-727-05) </PackageDescription>
<NDC11Code>42806-0727-05</NDC11Code>
<ProductNDC>42806-727</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213854</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol Succinate Extended-Release Tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropyl amino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethyl ether and heptane. Inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose, hypromellose, lactose monohydrate (25 mg and 50 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, sugar spheres (composed of corn starch and sucrose), talc, titanium dioxide and triethyl citrate. FDA approved dissolution test specifications differ from USP.</Description>
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<NDC>
<NDCCode>55111-727-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-727-05) </PackageDescription>
<NDC11Code>55111-0727-05</NDC11Code>
<ProductNDC>55111-727</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201576</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ropinirole extended-release tablets, USP contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is:. Ropinirole hydrochloride USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>67777-727-05</NDCCode>
<PackageDescription>4 BOX in 1 CASE (67777-727-05) / 6 TUBE in 1 BOX (67777-727-04) / 113 g in 1 TUBE (67777-727-03) </PackageDescription>
<NDC11Code>67777-0727-05</NDC11Code>
<ProductNDC>67777-727</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antifungal</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260324</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Dynarex Corporation</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). Relieves itching, scaling, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch and itching, burning feet.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68462-727-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68462-727-05) </PackageDescription>
<NDC11Code>68462-0727-05</NDC11Code>
<ProductNDC>68462-727</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Saxagliptin</ProprietaryName>
<NonProprietaryName>Saxagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205994</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>SAXAGLIPTIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Saxagliptin is an orally-active inhibitor of the DPP-4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2H2O and the molecular weight is 333.43. The structural formula is. Saxagliptin monohydrate is a white to off-white powder. It is soluble in methanol, ethanol; sparingly soluble in water. Each film-coated tablet of saxagliptin for oral use contains either 2.79 mg saxagliptin hydrochloride equivalent to 2.5 mg saxagliptin or 5.58 mg saxagliptin hydrochloride equivalent to 5 mg saxagliptin and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: hypromellose, iron oxide yellow (2.5 mg tablet only), iron oxide red (5 mg tablet only), polyethylene glycol and titanium dioxide. The imprinting ink contains the following: ammonium hydroxide, n-butyl alcohol, FD&C blue #2, isopropyl alcohol, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>76420-727-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (76420-727-05) </PackageDescription>
<NDC11Code>76420-0727-05</NDC11Code>
<ProductNDC>76420-727</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200562</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. It has the following chemical structure. C 17H 14F 3N 3O 2S M.W. 381.38. Celecoxib, USP is a white to almost white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib, USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: black iron oxide, crospovidone, dehydrated alcohol, FD&C Blue No.1, gelatin, lactose monohydrate, magnesium stearate, povidone, shellac, sodium lauryl sulfate, and titanium dioxide. The 50 mg, 200 mg and 400 mg capsules also contain D&C Yellow No. 10. The 50 mg, 100 mg and 200 mg capsules also contain D&C Red No. 28. The 400 mg capsule also contains FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>66096-113-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-113-05)</PackageDescription>
<NDC11Code>66096-0113-05</NDC11Code>
<ProductNDC>66096-113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anxiety/stress Relief</ProprietaryName>
<NonProprietaryName>Argentum Nitricum, Aurum Metallicum, Avena Sativa, Gelsemium Sempervirens, Hyoscyamus Niger, Ignatia Amara, Moschus, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS WHOLE; SODIUM CHLORIDE; PASSIFLORA INCARNATA TOP; TIN; VALERIAN</SubstanceName>
<StrengthNumber>8; 13; 2; 13; 13; 13; 13; 13; 2; 13; 2</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>66096-114-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-114-05) </PackageDescription>
<NDC11Code>66096-0114-05</NDC11Code>
<ProductNDC>66096-114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Bryonia Alba, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Kali Bichromicum, Kali Lodatum, Zincum Gluconicum.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170109</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; ZINC GLUCONATE</SubstanceName>
<StrengthNumber>4; 6; 4; 4; 6; 6; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms caused by the common cold.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-115-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-115-05) </PackageDescription>
<NDC11Code>66096-0115-05</NDC11Code>
<ProductNDC>66096-115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cough Relief</ProprietaryName>
<NonProprietaryName>Aconitum Nap, Antimon Crud, Antimon Sulph, Antimon Tart, Aralia Rac, Bryonia, Chelidonium Maj, Cuprum Met, Drosera, Hepar Sulph Calc, Kali Carb, Spongia.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150521</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ANTIMONY PENTASULFIDE; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COPPER; DROSERA ROTUNDIFOLIA; CALCIUM SULFIDE; POTASSIUM CARBONATE; SPONGIA OFFICINALIS SKELETON, ROASTED</SubstanceName>
<StrengthNumber>6; 8; 8; 8; 4; 6; 6; 12; 6; 12; 12; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves cough symptoms of diverse origins. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-119-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, GLASS (66096-119-05) </PackageDescription>
<NDC11Code>66096-0119-05</NDC11Code>
<ProductNDC>66096-119</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Immune Complex</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Echinacea Angustifolia, Ferrum Phosphoricum, Kali Muriaticum, Liver Extractum, Pituitarum Posterium, Placenta Totalis Suis, Viscum Album.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; MAMMAL LIVER; SUS SCROFA PITUITARY GLAND, POSTERIOR; SUS SCROFA PLACENTA; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>8; 3; 6; 4; 8; 8; 8; 3</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>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>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Temporarily relieves general immune system disorders.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-120-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-120-05) </PackageDescription>
<NDC11Code>66096-0120-05</NDC11Code>
<ProductNDC>66096-120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Fatigue Relief</ProprietaryName>
<NonProprietaryName>Aceticum Ac, Adrenal Gland, Arnica, Benzoicum Ac, Ferrum Phos, Fluoricum Ac, Ginseng, Kali Carb, Kali Lod, Kali Mur, Kali Phos, Lacticum Ac, Phosphoricum Ac, Picricum Ac.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150521</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ACETIC ACID; BOS TAURUS ADRENAL GLAND; ARNICA MONTANA; BENZOIC ACID; FERROSOFERRIC PHOSPHATE; HYDROFLUORIC ACID; ASIAN GINSENG; POTASSIUM CARBONATE; POTASSIUM IODIDE; POTASSIUM CHLORIDE; DIBASIC POTASSIUM PHOSPHATE; LACTIC ACID, DL-; PHOSPHORIC ACID; PICRIC ACID</SubstanceName>
<StrengthNumber>30; 10; 12; 30; 6; 30; 3; 4; 3; 3; 3; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nitrogen Binding Agent [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves general weakness. Improves stamina.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-121-05</NDCCode>
<PackageDescription>59 mL in 1 PACKAGE (66096-121-05) </PackageDescription>
<NDC11Code>66096-0121-05</NDC11Code>
<ProductNDC>66096-121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Fever Relief</ProprietaryName>
<NonProprietaryName>Aconitum Nap, Baptisia, Belladonna, Bryonia, Chamomilla, Eupatorium Perf, Gelsemium, Rhus Tox.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120607</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA CHAMOMILLA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>6; 24; 6; 6; 4; 6; 5; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves fever symptoms, helps the body fight viral and bacterial infections.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-122-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-122-05) </PackageDescription>
<NDC11Code>66096-0122-05</NDC11Code>
<ProductNDC>66096-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ohm Pituitarum Complex</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Adrenocorticotrophin, Cerebrum, Liver Gland, Pituitarum Posterium Gland, Placenta, Thyroidinum.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>EPINEPHRINE; CORTICOTROPIN; SUS SCROFA CEREBRUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND, POSTERIOR; SUS SCROFA PLACENTA; THYROID, UNSPECIFIED</SubstanceName>
<StrengthNumber>10; 10; 14; 10; 10; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves endocrine system imbalance (glands - hormones).**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-125-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-125-05) </PackageDescription>
<NDC11Code>66096-0125-05</NDC11Code>
<ProductNDC>66096-125</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Weight Control</ProprietaryName>
<NonProprietaryName>Aceticum Ac, Anacard Or, Baryta Iod, Calc Carb, Capsicum, Fucus, Graphites,, Nat Sulphuricum, Phytolacca, Stannum Met, Thyroidinum, Zinc Met.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130930</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ACETIC ACID; SEMECARPUS ANACARDIUM JUICE; BARIUM IODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; FUCUS VESICULOSUS; GRAPHITE; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; TIN; THYROID, UNSPECIFIED; ZINC</SubstanceName>
<StrengthNumber>10; 14; 12; 14; 14; 5; 14; 14; 7; 16; 12; 14</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves food cravings. Helps control appetite and balance metabolism to reduce weight gain. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-153-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-153-05) </PackageDescription>
<NDC11Code>66096-0153-05</NDC11Code>
<ProductNDC>66096-153</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Pancreas Aid</ProprietaryName>
<NonProprietaryName>Helonias Dioica, Lacticum Acidum, Pancreas Suis, Pancreatinum, Phosphoricum Acidum, Phosphorus, Syzygium Jambolanum, Thyroidinum, Uranium Nitricum.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150803</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>CHAMAELIRIUM LUTEUM ROOT; LACTIC ACID, DL-; SUS SCROFA PANCREAS; PANCRELIPASE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; THYROID, UNSPECIFIED; URANYL NITRATE HEXAHYDRATE</SubstanceName>
<StrengthNumber>30; 4; 8; 14; 10; 10; 3; 8; 12</StrengthNumber>
<StrengthUnit>[hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves metabolic pancreas dysfunctions.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-154-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-154-05) </PackageDescription>
<NDC11Code>66096-0154-05</NDC11Code>
<ProductNDC>66096-154</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Sore Throat</ProprietaryName>
<NonProprietaryName>Aconitum Nap, Ailanthus, Baptisia, Belladonna, Ferrum Phos, Hepar Sulph Calc, Hydrastis, Merc Cyan, Merc Iod Rub, Phytolacca.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20170410</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; AILANTHUS ALTISSIMA FLOWERING TWIG; BAPTISIA TINCTORIA; ATROPA BELLADONNA; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; GOLDENSEAL; MERCURIC CYANIDE; MERCURIC IODIDE; PHYTOLACCA AMERICANA ROOT</SubstanceName>
<StrengthNumber>7; 16; 3; 7; 6; 12; 3; 16; 8; 3</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms caused by common throat irritation.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-156-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-156-05) </PackageDescription>
<NDC11Code>66096-0156-05</NDC11Code>
<ProductNDC>66096-156</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Menopause</ProprietaryName>
<NonProprietaryName>Ammonium Carbonicum, Amyl Nitrosum, Cimicifuga Racemosa, Glonoinum, Lachesis Mutus, Sanguinaria, Canadensis.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150819</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>AMMONIUM CARBONATE; AMYL NITRITE; BLACK COHOSH; NITROGLYCERIN; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT</SubstanceName>
<StrengthNumber>12; 6; 3; 12; 12; 4</StrengthNumber>
<StrengthUnit>[hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms caused by common menopause, hormonal imbalances. ** This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-157-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, GLASS (66096-157-05) </PackageDescription>
<NDC11Code>66096-0157-05</NDC11Code>
<ProductNDC>66096-157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ohm Parasites</ProprietaryName>
<NonProprietaryName>Chenopodium Anthelminticum, Cina, Cucurbita, Pepo, Cuprum Oxydatum Nigrum, Filix Mas, Granatum, Kousso, Ratanhia, Santoninum, Sabadilla, Spigelia, Teucrium Marum.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150819</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; PUMPKIN SEED; CUPRIC OXIDE; DRYOPTERIS FILIX-MAS ROOT; PUNICA GRANATUM ROOT BARK; HAGENIA ABYSSINICA FLOWER; KRAMERIA LAPPACEA ROOT; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SPIGELIA MARILANDICA ROOT; TEUCRIUM MARUM</SubstanceName>
<StrengthNumber>6; 6; 3; 12; 4; 4; 7; 4; 10; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms caused by parasites and worms such as bloating, itching and intestinal dysfunction.**. ** This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-158-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-158-05)</PackageDescription>
<NDC11Code>66096-0158-05</NDC11Code>
<ProductNDC>66096-158</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Allium Cepa, Apis Mellifica, Aralia Racemosa, Blatta Orientalis, Euphrasia Officinalis, Galphimia Glauca, Hedera Helix, Luffa Operculata, Okoubaka, Sabadilla.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; BLATTA ORIENTALIS; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; LUFFA OPERCULATA FRUIT; OKOUBAKA AUBREVILLEI BARK; SCHOENOCAULON OFFICINALE SEED</SubstanceName>
<StrengthNumber>5; 5; 5; 5; 5; 5; 5; 5; 5; 5</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>USES: Temporarily relieves respiratory symptoms caused by common allergens.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-159-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, GLASS (66096-159-05) </PackageDescription>
<NDC11Code>66096-0159-05</NDC11Code>
<ProductNDC>66096-159</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ohm Mouthwash</ProprietaryName>
<NonProprietaryName>Arnica Montana, Borax, Calendula Officinalis, Hypericum Perforatum, Myrrha, Plantago Major, Ratanhia, Salvia Officinalis, Symphytum Officinale.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ARNICA MONTANA; SODIUM BORATE; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; MYRRH; PLANTAGO MAJOR; KRAMERIA LAPPACEA ROOT; SAGE; COMFREY ROOT</SubstanceName>
<StrengthNumber>3; 3; 1; 3; 3; 1; 3; 1; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves sensitive, bleeding gums and gingivitis.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-168-05</NDCCode>
<PackageDescription>59 mL in 1 PACKAGE (66096-168-05) </PackageDescription>
<NDC11Code>66096-0168-05</NDC11Code>
<ProductNDC>66096-168</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acne Relief</ProprietaryName>
<NonProprietaryName>Antimonium Crud, Arsenicum Brom, Bovista, Eugenia Jamb, Fluoricum Acidum, Hepar Sulph Calc, Kali Brom, Kali Iod, Kali Mur, Nat Brom, Niccolum Sulph, Phosphoricum Ac, Sulphur Iod.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150521</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; ARSENIC TRIBROMIDE; LYCOPERDON UTRIFORME FRUITING BODY; SYZYGIUM JAMBOS SEED; HYDROFLUORIC ACID; CALCIUM SULFIDE; POTASSIUM BROMIDE; POTASSIUM IODIDE; POTASSIUM CHLORIDE; SODIUM BROMIDE; NICKEL SULFATE HEXAHYDRATE; PHOSPHORIC ACID; SULFUR IODIDE</SubstanceName>
<StrengthNumber>6; 30; 30; 14; 30; 30; 3; 3; 6; 4; 4; 30; 14</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>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>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves pustular eruptions, acne simplex and indurate. Helps prevent recurrence of bluish red and acne eruptions.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-191-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-191-05) </PackageDescription>
<NDC11Code>66096-0191-05</NDC11Code>
<ProductNDC>66096-191</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Cholesterol Aid</ProprietaryName>
<NonProprietaryName>Cholesterinum, Fel Tauri, Guatteria Guameri.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>CHOLESTEROL; BOS TAURUS BILE; MALMEA DEPRESSA BARK</SubstanceName>
<StrengthNumber>13; 3; 5</StrengthNumber>
<StrengthUnit>[hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves ailments related with slow hepatic metabolism resulting in elevated cholesterol levels.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-192-05</NDCCode>
<PackageDescription>59 mL in 1 PACKAGE (66096-192-05) </PackageDescription>
<NDC11Code>66096-0192-05</NDC11Code>
<ProductNDC>66096-192</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eczema Relief</ProprietaryName>
<NonProprietaryName>Arsenicum Iodatum, Kali Bromatum, Kali Muriaticum, Natrum Bromatum, Niccolum Sulphuricum, Sulphur Iodatum, Viola Tricolor, Zincum Bromatum.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150522</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ARSENIC TRIIODIDE; POTASSIUM BROMIDE; POTASSIUM CHLORIDE; SODIUM BROMIDE; NICKEL SULFATE HEXAHYDRATE; SULFUR IODIDE; VIOLA TRICOLOR; ZINC BROMIDE</SubstanceName>
<StrengthNumber>8; 4; 4; 4; 5; 14; 12; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves eczema - psoriatic skin symptoms.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-669-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-669-05) </PackageDescription>
<NDC11Code>66096-0669-05</NDC11Code>
<ProductNDC>66096-669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Allergy Animal Mix</ProprietaryName>
<NonProprietaryName>Cat Hair, Cattle, Dog, Guinea Pig, Hamster, Hog, Mouse, Rabbit Hair And Epithelia, Chicken, Duck, Goose Feathers, Horse Hair And Dander, Histaminum.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130313</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>FELIS CATUS HAIR; BOS TAURUS HAIR; CANIS LUPUS FAMILIARIS HAIR; CAVIA PORCELLUS HAIR; MESOCRICETUS AURATUS SKIN; SUS SCROFA HAIR; MUS MUSCULUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; ORYCTOLAGUS CUNICULUS SKIN; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; EQUUS CABALLUS HAIR; EQUUS CABALLUS DANDER; HISTAMINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 60</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; 1/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Cells, Epidermal [EXT], Cells, Epidermal [EXT], Dander [CS], Dander [CS], Feathers [CS], Feathers [CS], Feathers [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Animal Dander Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Skin Allergenic Extract [EPC], Non-Standardized Animal Skin Allergenic Extract [EPC], Non-Standardized Feather Allergenic Extract [EPC], Non-Standardized Feather Allergenic Extract [EPC], Non-Standardized Feather Allergenic Extract [EPC], Salivary Proteins and Peptides [CS], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves allergy symptoms associated with exposure to hair, feathers, dander, and/or epithelia from animals.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-670-05</NDCCode>
<PackageDescription>59 mL in 1 PACKAGE (66096-670-05) </PackageDescription>
<NDC11Code>66096-0670-05</NDC11Code>
<ProductNDC>66096-670</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Allergy Mold Mix</ProprietaryName>
<NonProprietaryName>Alternaria Alt, Aspergillus Fum, Aspergillus Nig, Boletus Sat, Botrytis Cin, Candida Alb, Cladosporium Met, Fusarium Oxy, Helminthosporium, Murcor Mue, Pullularia Pul, Rhizopus Nig, Ustaligo, Histaminum.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151029</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; BOLETUS SATANAS FRUITING BODY; BOTRYTIS CINEREA; CANDIDA ALBICANS; PASSALORA FULVA; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; USTILAGO MAYDIS; HISTAMINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>14; 14; 14; 14; 14; 14; 14; 14; 14; 14; 14; 14; 60</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves sneezing, runny nose, itchy eyes associated with exposure to molds and fungi.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-671-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, GLASS (66096-671-05) </PackageDescription>
<NDC11Code>66096-0671-05</NDC11Code>
<ProductNDC>66096-671</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Allergy Grass, Weed, Tree Mix</ProprietaryName>
<NonProprietaryName>Bermuda, Birch Mix, Brome, Carduus Marianus, Chelidonium Majus, Common Mugwort, English Plantain, Goldenrod, Hydrastis Canadensis, Histam, Johnson, Kentucky, Maple Mix, Nasturtium Aqua, Oak Mix, Orchard, Pigweed Mix, Pine Mix, Ragweed Mix, Red Cedar, Red Mulb, Scrophularia Nod, Sheep Sorrel, Soildago Virg, Sweet Vernal, Taraxacum Offi, Timothy, White Poplar.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130313</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ACER PSEUDOPLATANUS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA VULGARIS POLLEN; BETULA PENDULA WHOLE; BROMUS SECALINUS TOP; CHELIDONIUM MAJUS; CYNODON DACTYLON; DACTYLIS GLOMERATA POLLEN; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA POLLEN; MILK THISTLE; MORUS RUBRA POLLEN; NASTURTIUM OFFICINALE; PHLEUM PRATENSE POLLEN; PINUS MASSONIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; QUERCUS SPP. WHOLE; RUMEX ACETOSELLA POLLEN; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; SOLIDAGO VIRGAUREA POLLEN; SORGHUM HALEPENSE POLLEN; TARAXACUM OFFICINALE POLLEN</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 3; 6; 6; 5; 60; 6; 3; 6; 3; 6; 6; 6; 6; 6; 6; 6; 3; 3; 6; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves sneezing, runny nose, itchy eyes and congestion associated with exposure to grasses, weeds and trees. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-672-05</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, GLASS (66096-672-05) </PackageDescription>
<NDC11Code>66096-0672-05</NDC11Code>
<ProductNDC>66096-672</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vida Hair Oil</ProprietaryName>
<NonProprietaryName>Arnica Montana.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170102</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Temporarily relieves excessive hair loss.**. **The uses for our products are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-710-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-710-05) </PackageDescription>
<NDC11Code>66096-0710-05</NDC11Code>
<ProductNDC>66096-710</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Allium Cepa, Apis Mellifica, Aralia Racemosa, Blatta Orientalis, Bovista, Carduus Marianus, Chelidonium Majus, Euphrasia Officinalas, Galphimia Glauca, Hedera Helix, Hydrastis Canadensis, Luffa Operculata, Nasturtium Aquaticum, Okoubaka, Sabadilla, Scrophularia Nodosa, Solidago Virgaurea, Taraxacum Officinale.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170602</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; BLATTA ORIENTALIS; LYCOPERDON UTRIFORME FRUITING BODY; MILK THISTLE; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; GOLDENSEAL; LUFFA OPERCULATA FRUIT; NASTURTIUM OFFICINALE; OKOUBAKA AUBREVILLEI BARK; SCHOENOCAULON OFFICINALE SEED; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>5; 5; 5; 12; 12; 3; 3; 8; 5; 5; 5; 5; 3; 5; 5; 3; 5; 3</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves coryza, cough and itchy eyes symptoms associated with hay fever and common allergens.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-713-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-713-05) </PackageDescription>
<NDC11Code>66096-0713-05</NDC11Code>
<ProductNDC>66096-713</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anxiety Stress Relief</ProprietaryName>
<NonProprietaryName>Arg Nit, Aur Met, Avena, Gelsemium, Hyoscyamus, Ignatia, Moschus, Nat Mur, Passiflora, Stannum Met, Valeriana.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS WHOLE; SODIUM CHLORIDE; PASSIFLORA INCARNATA TOP; TIN; VALERIAN</SubstanceName>
<StrengthNumber>8; 13; 2; 13; 13; 13; 13; 13; 2; 13; 2</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves anxiety, irritability and nervousness due to every day stress.**. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
</NDCList>