{
"NDC": [
{
"NDCCode": "66096-724-05",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (66096-724-05) ",
"NDC11Code": "66096-0724-05",
"ProductNDC": "66096-724",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Detox Drainage Kidney",
"NonProprietaryName": "Apis Mel, Berber Vulg, Chimaphila Umb, Cuprum Met, Equisetum Hyem, Formica, Nat Sulphuricum, Sabal, Sarsaparilla, Solidago, Uva Ursi.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170321",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; CHIMAPHILA UMBELLATA; COPPER; EQUISETUM HYEMALE; FORMICA RUFA; SODIUM SULFIDE NONAHYDRATE; SAW PALMETTO; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF",
"StrengthNumber": "5; 3; 3; 14; 6; 6; 4; 3; 3; 3; 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",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170321",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves slow dysfunctional renal metabolism, stimulates kidney function to remove toxins and improve drainage.**. ā**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "23155-724-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (23155-724-05) ",
"NDC11Code": "23155-0724-05",
"ProductNDC": "23155-724",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074787",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200222",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] salicylamide monohydrochloride, and it has the following structural formula. C19H24N2O3 HCl M.W. 364.87. Labetalol hydrochloride, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R, R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP for oral administration, contains 100 mg, 200 mg, 300 mg, or 400 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, sodium starch glycolate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. In addition, the 100 mg tablets contain D&C yellow #10 aluminum lake and FD&C yellow # 6 aluminum lake and the 300 mg tablets contain D&C yellow #10 aluminum lake, FD&C yellow # 6 aluminum lake and FD&C blue#1 aluminum lake."
},
{
"NDCCode": "42806-724-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-724-05) ",
"NDC11Code": "42806-0724-05",
"ProductNDC": "42806-724",
"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": "25",
"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": "59651-724-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (59651-724-05) ",
"NDC11Code": "59651-0724-05",
"ProductNDC": "59651-724",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075150",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230117",
"SamplePackage": "N",
"IndicationAndUsage": "Seizure Disorders: Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect). Panic Disorder: Clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clonazepam tablets USP, a benzodiazepine, are available containing 0.5 mg, 1 mg or 2 mg of clonazepam, USP. The 0.5 mg tablets are yellow, approximately 7.93 mm, round, biconvex tablet debossed with '0.5' on one side and score on the other side. The 1 mg tablets are light green, approximately 7.93 mm, round, biconvex tablet debossed with '1' on one side and score on the other side. The 2 mg tablets are white, approximately 7.93 mm, round, biconvex tablet debossed with '2' on one side and score on the other side. Each tablet contains anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 0.5 mg tablets also contain D&C Yellow No. 10 Aluminum Lake and the 1 mg tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. Chemically, clonazepam, USP is 5-(o-Chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72, molecular formula of C15H10ClN303 and the following structural formula."
},
{
"NDCCode": "62856-724-30",
"PackageDescription": "6 BLISTER PACK in 1 BOX (62856-724-30) / 1 KIT in 1 BLISTER PACK (62856-724-05) ",
"NDC11Code": "62856-0724-30",
"ProductNDC": "62856-724",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lenvima",
"NonProprietaryName": "Lenvatinib",
"DosageFormName": "KIT",
"StartMarketingDate": "20150213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206947",
"LabelerName": "Eisai Inc.",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150213",
"SamplePackage": "N",
"IndicationAndUsage": "LENVIMA is a kinase inhibitor that is indicated:. Differentiated Thyroid Cancer (DTC) : 1 For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). (1.1).",
"Description": "LENVIMA, a kinase inhibitor, is the mesylate salt of lenvatinib. Its chemical name is 4-[3-chloro-4-(Nā-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carboxamide methanesulfonate. The molecular formula is C21H19ClN4O4 CH4O3S, and the molecular weight of the mesylate salt is 522.96. The chemical structure of lenvatinib mesylate is. Lenvatinib mesylate is a white to pale reddish yellow powder. It is slightly soluble in water and practically insoluble in ethanol (dehydrated). The dissociation constant (pKa value) of lenvatinib mesylate is 5.05 at 25°C. The partition coefficient (log P value) is 3.3. LENVIMA capsules for oral administration contain 4 mg or 10 mg of lenvatinib, equivalent to 4.90 mg or 12.25 mg of lenvatinib mesylate, respectively. The inactive ingredients are: calcium carbonate, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and talc. In addition, the capsule shell contains ferric oxide red, ferric oxide yellow, hypromellose, and titanium dioxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac."
},
{
"NDCCode": "63304-724-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-724-05) ",
"NDC11Code": "63304-0724-05",
"ProductNDC": "63304-724",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203650",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets, USP (XL) are aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1ā propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride, USP powder is white and soluble in water, in 0.1 N hydrochloric acid, and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 300 mg white to pale yellow extended-release tablets. Each extended-release tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: ethylcellulose, glyceryl behenate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, polyethylene glycol, povidone, silicon dioxide, stearic acid, and triethyl citrate. The tablets are printed with edible black ink which contains ferrosoferric oxide, propylene glycol, and shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP dissolution Test 24."
},
{
"NDCCode": "63323-724-05",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-724-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-724-01) ",
"NDC11Code": "63323-0724-05",
"ProductNDC": "63323-724",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Remifentanil Hydrochloride",
"NonProprietaryName": "Remifentanil Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206223",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "REMIFENTANIL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180119",
"SamplePackage": "N",
"IndicationAndUsage": "Remifentanil hydrochloride (HCl) for injection is indicated for intravenous (IV) administration: 1 As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures., 2 For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting., 3 As an analgesic component of monitored anesthesia care in adult patients.",
"Description": "Remifentanil hydrochloride for injection is an opioid agonist. The chemical name is 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt. The molecular weight is 412.91. Its molecular formula is C20H28N2O5HCl, and it has the following chemical structure. Remifentanil hydrochloride for injection is a sterile, nonpyrogenic, preservative-free, white to off-white lyophilized powder for intravenous (IV) administration after reconstitution and dilution. Each vial contains 1 mg, 2 mg, or 5 mg of remifentanil base; 15 mg glycine; and hydrochloric acid to buffer the solutions to a nominal pH of 3 after reconstitution. When reconstituted as directed, solutions of remifentanil HCl are clear and colorless and contain remifentanil hydrochloride (HCl) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of remifentanil HCl ranges from 2.5 to 3.5. Remifentanil HCl has a pKa of 7.07. Remifentanil HCl has an n-octanol:water partition coefficient of 17.9 at pH 7.3."
},
{
"NDCCode": "68462-724-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (68462-724-05) ",
"NDC11Code": "68462-0724-05",
"ProductNDC": "68462-724",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorzoxazone",
"NonProprietaryName": "Chlorzoxazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200526",
"EndMarketingDate": "20220701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212185",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CHLORZOXAZONE",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200526",
"EndMarketingDatePackage": "20220701",
"SamplePackage": "N"
},
{
"NDCCode": "76420-724-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (76420-724-05) ",
"NDC11Code": "76420-0724-05",
"ProductNDC": "76420-724",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210907",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240506",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is N-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride. The empirical formula C 21H 31N 5O 2HCl is represented by the following structural formula:. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "84756-724-05",
"PackageDescription": "100 mL in 1 BOTTLE (84756-724-05) ",
"NDC11Code": "84756-0724-05",
"ProductNDC": "84756-724",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Turmeric Oil",
"NonProprietaryName": "Trstay Turmeric Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"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.**. ā**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.**. ā**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. ā**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.**. ā**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. ** āThis 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.**. ** āThis 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.**. ā**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.**. ā**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. ā**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
}
]
}
{"NDC":[{"NDCCode":"66096-724-05","ProprietaryName":"Detox Drainage Kidney","NonProprietaryName":"Apis Mel, Berber Vulg, Chimaphila Umb, Cuprum Met, Equisetum Hyem, Formica, Nat Sulphuricum, Sabal, Sarsaparilla, Solidago, Uva Ursi."},{"NDCCode":"23155-724-05","ProprietaryName":"Labetalol Hydrochloride","NonProprietaryName":"Labetalol Hydrochloride"},{"NDCCode":"42806-724-05","ProprietaryName":"Metoprolol Succinate","NonProprietaryName":"Metoprolol Succinate"},{"NDCCode":"59651-724-05","ProprietaryName":"Clonazepam","NonProprietaryName":"Clonazepam"},{"NDCCode":"62856-724-30","ProprietaryName":"Lenvima","NonProprietaryName":"Lenvatinib"},{"NDCCode":"63304-724-05","ProprietaryName":"Bupropion Hydrochloride","NonProprietaryName":"Bupropion Hydrochloride"},{"NDCCode":"63323-724-05","ProprietaryName":"Remifentanil Hydrochloride","NonProprietaryName":"Remifentanil Hydrochloride"},{"NDCCode":"68462-724-05","ProprietaryName":"Chlorzoxazone","NonProprietaryName":"Chlorzoxazone"},{"NDCCode":"76420-724-05","ProprietaryName":"Buspirone Hydrochloride","NonProprietaryName":"Buspirone Hydrochloride"},{"NDCCode":"84756-724-05","ProprietaryName":"Trstay Turmeric Oil","NonProprietaryName":"Trstay Turmeric Oil"},{"NDCCode":"66096-113-05","ProprietaryName":"Anxiety/stress Relief","NonProprietaryName":"Argentum Nitricum, Aurum Metallicum, Avena Sativa, Gelsemium Sempervirens, Hyoscyamus Niger, Ignatia Amara, Moschus, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis."},{"NDCCode":"66096-114-05","ProprietaryName":"Cold","NonProprietaryName":"Aconitum Napellus, Bryonia Alba, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Kali Bichromicum, Kali Lodatum, Zincum Gluconicum."},{"NDCCode":"66096-115-05","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."},{"NDCCode":"66096-119-05","ProprietaryName":"Ohm Immune Complex","NonProprietaryName":"Adrenal Gland, Echinacea Angustifolia, Ferrum Phosphoricum, Kali Muriaticum, Liver Extractum, Pituitarum Posterium, Placenta Totalis Suis, Viscum Album."},{"NDCCode":"66096-120-05","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."},{"NDCCode":"66096-121-05","ProprietaryName":"Ohm Fever Relief","NonProprietaryName":"Aconitum Nap, Baptisia, Belladonna, Bryonia, Chamomilla, Eupatorium Perf, Gelsemium, Rhus Tox."},{"NDCCode":"66096-122-05","ProprietaryName":"Ohm Pituitarum Complex","NonProprietaryName":"Adrenal Gland, Adrenocorticotrophin, Cerebrum, Liver Gland, Pituitarum Posterium Gland, Placenta, Thyroidinum."},{"NDCCode":"66096-125-05","ProprietaryName":"Weight Control","NonProprietaryName":"Aceticum Ac, Anacard Or, Baryta Iod, Calc Carb, Capsicum, Fucus, Graphites,, Nat Sulphuricum, Phytolacca, Stannum Met, Thyroidinum, Zinc Met."},{"NDCCode":"66096-153-05","ProprietaryName":"Ohm Pancreas Aid","NonProprietaryName":"Helonias Dioica, Lacticum Acidum, Pancreas Suis, Pancreatinum, Phosphoricum Acidum, Phosphorus, Syzygium Jambolanum, Thyroidinum, Uranium Nitricum."},{"NDCCode":"66096-154-05","ProprietaryName":"Ohm Sore Throat","NonProprietaryName":"Aconitum Nap, Ailanthus, Baptisia, Belladonna, Ferrum Phos, Hepar Sulph Calc, Hydrastis, Merc Cyan, Merc Iod Rub, Phytolacca."},{"NDCCode":"66096-156-05","ProprietaryName":"Ohm Menopause","NonProprietaryName":"Ammonium Carbonicum, Amyl Nitrosum, Cimicifuga Racemosa, Glonoinum, Lachesis Mutus, Sanguinaria, Canadensis."},{"NDCCode":"66096-157-05","ProprietaryName":"Ohm Parasites","NonProprietaryName":"Chenopodium Anthelminticum, Cina, Cucurbita, Pepo, Cuprum Oxydatum Nigrum, Filix Mas, Granatum, Kousso, Ratanhia, Santoninum, Sabadilla, Spigelia, Teucrium Marum."},{"NDCCode":"66096-158-05","ProprietaryName":"Allergy Relief","NonProprietaryName":"Allium Cepa, Apis Mellifica, Aralia Racemosa, Blatta Orientalis, Euphrasia Officinalis, Galphimia Glauca, Hedera Helix, Luffa Operculata, Okoubaka, Sabadilla."},{"NDCCode":"66096-159-05","ProprietaryName":"Ohm Mouthwash","NonProprietaryName":"Arnica Montana, Borax, Calendula Officinalis, Hypericum Perforatum, Myrrha, Plantago Major, Ratanhia, Salvia Officinalis, Symphytum Officinale."},{"NDCCode":"66096-168-05","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."},{"NDCCode":"66096-191-05","ProprietaryName":"Ohm Cholesterol Aid","NonProprietaryName":"Cholesterinum, Fel Tauri, Guatteria Guameri."},{"NDCCode":"66096-192-05","ProprietaryName":"Eczema Relief","NonProprietaryName":"Arsenicum Iodatum, Kali Bromatum, Kali Muriaticum, Natrum Bromatum, Niccolum Sulphuricum, Sulphur Iodatum, Viola Tricolor, Zincum Bromatum."},{"NDCCode":"66096-669-05","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."},{"NDCCode":"66096-670-05","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."},{"NDCCode":"66096-671-05","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."}]}
ļ»æ<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>66096-724-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (66096-724-05) </PackageDescription>
<NDC11Code>66096-0724-05</NDC11Code>
<ProductNDC>66096-724</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Detox Drainage Kidney</ProprietaryName>
<NonProprietaryName>Apis Mel, Berber Vulg, Chimaphila Umb, Cuprum Met, Equisetum Hyem, Formica, Nat Sulphuricum, Sabal, Sarsaparilla, Solidago, Uva Ursi.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170321</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; CHIMAPHILA UMBELLATA; COPPER; EQUISETUM HYEMALE; FORMICA RUFA; SODIUM SULFIDE NONAHYDRATE; SAW PALMETTO; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF</SubstanceName>
<StrengthNumber>5; 3; 3; 14; 6; 6; 4; 3; 3; 3; 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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves slow dysfunctional renal metabolism, stimulates kidney function to remove toxins and improve drainage.**. ā**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23155-724-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (23155-724-05) </PackageDescription>
<NDC11Code>23155-0724-05</NDC11Code>
<ProductNDC>23155-724</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074787</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] salicylamide monohydrochloride, and it has the following structural formula. C19H24N2O3 HCl M.W. 364.87. Labetalol hydrochloride, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R, R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP for oral administration, contains 100 mg, 200 mg, 300 mg, or 400 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, sodium starch glycolate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. In addition, the 100 mg tablets contain D&C yellow #10 aluminum lake and FD&C yellow # 6 aluminum lake and the 300 mg tablets contain D&C yellow #10 aluminum lake, FD&C yellow # 6 aluminum lake and FD&C blue#1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>42806-724-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-724-05) </PackageDescription>
<NDC11Code>42806-0724-05</NDC11Code>
<ProductNDC>42806-724</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>25</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>
</NDC>
<NDC>
<NDCCode>59651-724-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (59651-724-05) </PackageDescription>
<NDC11Code>59651-0724-05</NDC11Code>
<ProductNDC>59651-724</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075150</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Seizure Disorders: Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect). Panic Disorder: Clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clonazepam tablets USP, a benzodiazepine, are available containing 0.5 mg, 1 mg or 2 mg of clonazepam, USP. The 0.5 mg tablets are yellow, approximately 7.93 mm, round, biconvex tablet debossed with '0.5' on one side and score on the other side. The 1 mg tablets are light green, approximately 7.93 mm, round, biconvex tablet debossed with '1' on one side and score on the other side. The 2 mg tablets are white, approximately 7.93 mm, round, biconvex tablet debossed with '2' on one side and score on the other side. Each tablet contains anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 0.5 mg tablets also contain D&C Yellow No. 10 Aluminum Lake and the 1 mg tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. Chemically, clonazepam, USP is 5-(o-Chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72, molecular formula of C15H10ClN303 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>62856-724-30</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 BOX (62856-724-30) / 1 KIT in 1 BLISTER PACK (62856-724-05) </PackageDescription>
<NDC11Code>62856-0724-30</NDC11Code>
<ProductNDC>62856-724</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lenvima</ProprietaryName>
<NonProprietaryName>Lenvatinib</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206947</ApplicationNumber>
<LabelerName>Eisai Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LENVIMA is a kinase inhibitor that is indicated:. Differentiated Thyroid Cancer (DTC) : 1 For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). (1.1).</IndicationAndUsage>
<Description>LENVIMA, a kinase inhibitor, is the mesylate salt of lenvatinib. Its chemical name is 4-[3-chloro-4-(Nā-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carboxamide methanesulfonate. The molecular formula is C21H19ClN4O4 CH4O3S, and the molecular weight of the mesylate salt is 522.96. The chemical structure of lenvatinib mesylate is. Lenvatinib mesylate is a white to pale reddish yellow powder. It is slightly soluble in water and practically insoluble in ethanol (dehydrated). The dissociation constant (pKa value) of lenvatinib mesylate is 5.05 at 25°C. The partition coefficient (log P value) is 3.3. LENVIMA capsules for oral administration contain 4 mg or 10 mg of lenvatinib, equivalent to 4.90 mg or 12.25 mg of lenvatinib mesylate, respectively. The inactive ingredients are: calcium carbonate, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and talc. In addition, the capsule shell contains ferric oxide red, ferric oxide yellow, hypromellose, and titanium dioxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>63304-724-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-724-05) </PackageDescription>
<NDC11Code>63304-0724-05</NDC11Code>
<ProductNDC>63304-724</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203650</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets, USP (XL) are aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1ā propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride, USP powder is white and soluble in water, in 0.1 N hydrochloric acid, and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 300 mg white to pale yellow extended-release tablets. Each extended-release tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: ethylcellulose, glyceryl behenate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, polyethylene glycol, povidone, silicon dioxide, stearic acid, and triethyl citrate. The tablets are printed with edible black ink which contains ferrosoferric oxide, propylene glycol, and shellac glaze. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP dissolution Test 24.</Description>
</NDC>
<NDC>
<NDCCode>63323-724-05</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (63323-724-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-724-01) </PackageDescription>
<NDC11Code>63323-0724-05</NDC11Code>
<ProductNDC>63323-724</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Remifentanil Hydrochloride</ProprietaryName>
<NonProprietaryName>Remifentanil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206223</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>REMIFENTANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Remifentanil hydrochloride (HCl) for injection is indicated for intravenous (IV) administration: 1 As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures., 2 For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting., 3 As an analgesic component of monitored anesthesia care in adult patients.</IndicationAndUsage>
<Description>Remifentanil hydrochloride for injection is an opioid agonist. The chemical name is 3-[4-methoxycarbonyl-4-[(1-oxopropyl)phenylamino]-1-piperidine]propanoic acid methyl ester, hydrochloride salt. The molecular weight is 412.91. Its molecular formula is C20H28N2O5HCl, and it has the following chemical structure. Remifentanil hydrochloride for injection is a sterile, nonpyrogenic, preservative-free, white to off-white lyophilized powder for intravenous (IV) administration after reconstitution and dilution. Each vial contains 1 mg, 2 mg, or 5 mg of remifentanil base; 15 mg glycine; and hydrochloric acid to buffer the solutions to a nominal pH of 3 after reconstitution. When reconstituted as directed, solutions of remifentanil HCl are clear and colorless and contain remifentanil hydrochloride (HCl) equivalent to 1 mg/mL of remifentanil base. The pH of reconstituted solutions of remifentanil HCl ranges from 2.5 to 3.5. Remifentanil HCl has a pKa of 7.07. Remifentanil HCl has an n-octanol:water partition coefficient of 17.9 at pH 7.3.</Description>
</NDC>
<NDC>
<NDCCode>68462-724-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (68462-724-05) </PackageDescription>
<NDC11Code>68462-0724-05</NDC11Code>
<ProductNDC>68462-724</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorzoxazone</ProprietaryName>
<NonProprietaryName>Chlorzoxazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200526</StartMarketingDate>
<EndMarketingDate>20220701</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212185</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CHLORZOXAZONE</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200526</StartMarketingDatePackage>
<EndMarketingDatePackage>20220701</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76420-724-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (76420-724-05) </PackageDescription>
<NDC11Code>76420-0724-05</NDC11Code>
<ProductNDC>76420-724</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210907</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is N-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride. The empirical formula C 21H 31N 5O 2HCl is represented by the following structural formula:. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>84756-724-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (84756-724-05) </PackageDescription>
<NDC11Code>84756-0724-05</NDC11Code>
<ProductNDC>84756-724</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Turmeric Oil</ProprietaryName>
<NonProprietaryName>Trstay Turmeric Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</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.**. ā**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.**. ā**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. ā**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.**. ā**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. ** āThis 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.**. ** āThis 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.**. ā**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.**. ā**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. ā**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
</NDCList>