{
"NDC": [
{
"NDCCode": "62106-1145-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1145-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1145-08",
"ProductNDC": "62106-1145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 46",
"NonProprietaryName": "Absinthium, Jateorhiza Palmata Root, Condurango Bark, Mentha Piperita, Aloe Socotrina, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150209",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "ALOE; SILVER; WORMWOOD; JATEORHIZA CALUMBA ROOT; MARSDENIA CONDURANGO BARK; MENTHA PIPERITA",
"StrengthNumber": "10; 12; 4; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Status": "Active",
"LastUpdate": "2022-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150209",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For the temporary relief of symptoms associated with indigestion lack of appetite stomach aches. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "0023-1145-01",
"PackageDescription": "1 VIAL in 1 CARTON (0023-1145-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "00023-1145-01",
"ProductNDC": "0023-1145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Botox",
"NonProprietaryName": "Onabotulinumtoxina",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRADERMAL; INTRAMUSCULAR",
"StartMarketingDate": "19891215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103000",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "BOTULINUM TOXIN TYPE A",
"StrengthNumber": "100",
"StrengthUnit": "[USP'U]/1",
"Pharm_Classes": "Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19891215",
"SamplePackage": "N",
"IndicationAndUsage": "BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: 1 Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication (1.1), 2 Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication (1.1), 3 Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. (1.2), 4 Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer) (1.3), 5 Treatment of spasticity in patients 2 years of age and older (1.4), 6 Treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain (1.5) , 7 Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients (1.6), 8 Treatment of blepharospasm associated with dystonia in patients 12 years of age and older (1.7), 9 Treatment of strabismus in patients 12 years of age and older (1.7).",
"Description": "OnabotulinumtoxinA is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying. The primary release procedure for BOTOX uses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to AbbVie’s products BOTOX and BOTOX Cosmetic. One Unit of BOTOX corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. Due to specific details of this assay such as the vehicle, dilution scheme, and laboratory protocols, Units of biological activity of BOTOX cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX is approximately 20 Units/nanogram of neurotoxin protein complex. Each vial of BOTOX (onabotulinumtoxinA) for injection contains either 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative."
},
{
"NDCCode": "0023-1145-02",
"PackageDescription": "1 VIAL in 1 CARTON (0023-1145-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "00023-1145-02",
"ProductNDC": "0023-1145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Botox",
"NonProprietaryName": "Onabotulinumtoxina",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRADERMAL; INTRAMUSCULAR",
"StartMarketingDate": "19891215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103000",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "BOTULINUM TOXIN TYPE A",
"StrengthNumber": "100",
"StrengthUnit": "[USP'U]/1",
"Pharm_Classes": "Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19891215",
"SamplePackage": "Y",
"IndicationAndUsage": "BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: 1 Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication (1.1), 2 Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication (1.1), 3 Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. (1.2), 4 Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer) (1.3), 5 Treatment of spasticity in patients 2 years of age and older (1.4), 6 Treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain (1.5) , 7 Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients (1.6), 8 Treatment of blepharospasm associated with dystonia in patients 12 years of age and older (1.7), 9 Treatment of strabismus in patients 12 years of age and older (1.7).",
"Description": "OnabotulinumtoxinA is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying. The primary release procedure for BOTOX uses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to AbbVie’s products BOTOX and BOTOX Cosmetic. One Unit of BOTOX corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. Due to specific details of this assay such as the vehicle, dilution scheme, and laboratory protocols, Units of biological activity of BOTOX cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX is approximately 20 Units/nanogram of neurotoxin protein complex. Each vial of BOTOX (onabotulinumtoxinA) for injection contains either 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative."
},
{
"NDCCode": "0338-1145-03",
"PackageDescription": "1000 mL in 1 BAG (0338-1145-03) ",
"NDC11Code": "00338-1145-03",
"ProductNDC": "0338-1145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix E",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970326",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020678",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
"StrengthNumber": "311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 297; 261; 51; 77; 33; 10",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19970326",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0378-1145-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-1145-01) ",
"NDC11Code": "00378-1145-01",
"ProductNDC": "0378-1145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076008",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130731",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets 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 have 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 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, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 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 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 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 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 are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Buspirone hydrochloride tablets are supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 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 and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg 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). A single 30 mg 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 contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate (potato)."
},
{
"NDCCode": "60219-1145-3",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (60219-1145-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "60219-1145-03",
"ProductNDC": "60219-1145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darunavir",
"NonProprietaryName": "Darunavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212493",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "DARUNAVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231209",
"SamplePackage": "N",
"IndicationAndUsage": "Darunavir, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].",
"Description": "Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. It has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester. Its molecular formula is C27H37N3O7S and its molecular weight is 547.66 g/mol. Darunavir has the following structural formula. Darunavir is a white to creamish solid. It is freely soluble in ethyl acetate and in dichloromethane; practically insoluble in water. Each darunavir tablet contains 600 mg or 800 mg of darunavir. It also contains the inactive ingredients: colloidal silicon dioxide, crospovidone Type A, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate Type A. The 600 mg tablet film-coating, OPADRY-II Orange, contains FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film-coating, OPADRY-II Brown, contains ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide."
},
{
"NDCCode": "62106-1100-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (62106-1100-8) > 20 mL in 1 BOTTLE",
"NDC11Code": "62106-1100-08",
"ProductNDC": "62106-1100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 1",
"NonProprietaryName": "Achillea Millefolium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "ACHILLEA MILLEFOLIUM; ARCTOSTAPHYLOS UVA-URSI LEAF; VALERIAN; ANGELICA ARCHANGELICA ROOT; EQUISETUM ARVENSE TOP; LYCOPODIUM CLAVATUM SPORE; LARIX DECIDUA RESIN; SILVER",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 5; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Status": "Active",
"LastUpdate": "2022-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140701",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For the temporary relief of symptoms associated with indigestion fatigue following meals occasional headaches. Directions. Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "62106-1101-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1101-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1101-08",
"ProductNDC": "62106-1101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 2",
"NonProprietaryName": "Petroselinum Sativum, Rhamnus Frangula, Thlaspi Bursa-pastoris, Juniperus Communis, Asparagus Officinalis, Berberis Vulgaris, Genista Tinctoria, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150526",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK; PETROSELINUM CRISPUM; ASPARAGUS; FRANGULA ALNUS BARK; CAPSELLA BURSA-PASTORIS; SILVER; GENISTA TINCTORIA; JUNIPER BERRY",
"StrengthNumber": "4; 4; 4; 4; 4; 12; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1102-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1102-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1102-08",
"ProductNDC": "62106-1102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 3",
"NonProprietaryName": "Equisetum Arvense Stem, Chamomilla, Condurango Bark, Viola Tricolor, Boldo Leaf, Aluminium Metallicum, Stannum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150507",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "EQUISETUM ARVENSE TOP; MATRICARIA RECUTITA; MARSDENIA CONDURANGO BARK; VIOLA TRICOLOR; PEUMUS BOLDUS LEAF; ALUMINUM; TIN",
"StrengthNumber": "4; 4; 4; 4; 4; 12; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150507",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1103-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1103-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1103-08",
"ProductNDC": "62106-1103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 4",
"NonProprietaryName": "Laurus Nobilis, Condurango, Rhamnus Frangula, Menyanthes Trifoliata, Absinthium, Jateorhiza Palmata, Argentum Metallicum, Antimonium Crudum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "FRANGULA ALNUS BARK; MENYANTHES TRIFOLIATA; WORMWOOD; JATEORHIZA CALUMBA ROOT; SILVER; ANTIMONY TRISULFIDE; BAY LEAF; MARSDENIA CONDURANGO BARK",
"StrengthNumber": "4; 4; 4; 4; 12; 12; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"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": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1104-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1104-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1104-08",
"ProductNDC": "62106-1104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 5",
"NonProprietaryName": "Tormentilla, Tussilago Farfara, Adiantum Capillus-veneris, Glycyrrhiza Glabra, Drosera, Grindelia, Inula Helenium, Cuprum Metallicum, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "POTENTILLA ERECTA ROOT; ADIANTUM CAPILLUS-VENERIS LEAF; DROSERA ROTUNDIFOLIA FLOWERING TOP; GLYCYRRHIZA GLABRA; GRINDELIA HIRSUTULA FLOWERING TOP; INULA HELENIUM ROOT; COPPER; SILVER; TUSSILAGO FARFARA WHOLE",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 12; 12; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150602",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1105-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1105-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1105-08",
"ProductNDC": "62106-1105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 6",
"NonProprietaryName": "Senna Leaflet, Rhamnus Frangula Bark, Carum Carvi, Foeniculum Vulgare, Illicium Verum, Rhamnus Cathartica, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150526",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "SENNA LEAF; FRANGULA ALNUS BARK; CARAWAY SEED; FENNEL SEED; ILLICIUM VERUM WHOLE; RHAMNUS CATHARTICA FRUIT; SILVER",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"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], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150526",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1106-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1106-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1106-08",
"ProductNDC": "62106-1106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 7",
"NonProprietaryName": "Equisetum Arvense, Uva-ursi, Juniperus Communis, Cytisus Scoparius, Hieraciumpilosella, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150507",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "HIERACIUM PILOSELLA WHOLE; EQUISETUM ARVENSE TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; JUNIPERUS COMMUNIS WHOLE; CYTISUS SCOPARIUS FLOWERING TOP; SILVER",
"StrengthNumber": "4; 4; 4; 4; 4; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150507",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1107-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1107-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1107-08",
"ProductNDC": "62106-1107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 8",
"NonProprietaryName": "Hamamelis Virginiana, Millefolium, Equisetum Arvense, Mercurialis Perennis, Thlaspi Bursa-pastoris, Cactus Grandiflorus, Crataegus, Cuprum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "HAMAMELIS VIRGINIANA BARK; MERCURIALIS PERENNIS; CRATAEGUS FRUIT; COPPER; ACHILLEA MILLEFOLIUM; EQUISETUM ARVENSE BRANCH; CAPSELLA BURSA-PASTORIS; SELENICEREUS GRANDIFLORUS STEM",
"StrengthNumber": "4; 4; 4; 12; 4; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150602",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1108-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1108-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1108-08",
"ProductNDC": "62106-1108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 9",
"NonProprietaryName": "Mentha Piperita, Melissa Officinalis, Salvia Pratensis, Thymus Vulgaris, Valeriana Officinalis, Aurum Metallicum, Plumbum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150527",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "GOLD; THYMUS VULGARIS WHOLE; VALERIAN; LEAD; MENTHA PIPERITA; SALVIA PRATENSIS LEAF; MELISSA OFFICINALIS",
"StrengthNumber": "12; 4; 4; 12; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150527",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1109-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1109-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1109-08",
"ProductNDC": "62106-1109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 10",
"NonProprietaryName": "Absinthium, Argentum Metallicum, Equisetum Arvense, Juniperus Communis, Millefolium, Rhamnus Frangula",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150929",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "SILVER; EQUISETUM ARVENSE BRANCH; JUNIPER BERRY; WORMWOOD; ACHILLEA MILLEFOLIUM; FRANGULA ALNUS BARK",
"StrengthNumber": "12; 4; 4; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150929",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1110-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1110-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1110-08",
"ProductNDC": "62106-1110",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 11",
"NonProprietaryName": "Asparagus Officinalis Young Shoot, Mentha Piperita Whole Plant, Millefolium Whole Plant,thymus Serpyllum Whole Plant, Crocus Sativus Dried Stigma, Rosmarinus Officinalis Flowering Twigs, Glechoma Hederacea Whole Plant, Verbena Officinalis Whole Plant, Uva-ursi Leaf, Cuprum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150224",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "VERBENA OFFICINALIS; COPPER; ASPARAGUS; GLECHOMA HEDERACEA; ARCTOSTAPHYLOS UVA-URSI LEAF; MENTHA PIPERITA; ACHILLEA MILLEFOLIUM; THYMUS SERPYLLUM; SAFFRON; ROSMARINUS OFFICINALIS FLOWERING TOP",
"StrengthNumber": "4; 12; 4; 4; 4; 4; 4; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150224",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For the temporary relief of minor pain associated with headaches. joints. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years) Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "62106-1112-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (62106-1112-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1112-08",
"ProductNDC": "62106-1112",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 13",
"NonProprietaryName": "Boldo Leaf, Ricinus Communis Seed, Combretum Raimbaultii Leaf, Jateorhiza Palmata Root, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20141217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "SILVER; PEUMUS BOLDUS LEAF; RICINUS COMMUNIS SEED; COMBRETUM MICRANTHUM LEAF; JATEORHIZA CALUMBA ROOT",
"StrengthNumber": "12; 4; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141217",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For the temporary relief of symptoms associated with digestive upset. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years) Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "62106-1113-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1113-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1113-08",
"ProductNDC": "62106-1113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 14",
"NonProprietaryName": "Eucalyptus Globulus, Inula Helenium, Jateorhiza Palmata, Camphora, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "INULA HELENIUM ROOT; JATEORHIZA CALUMBA ROOT; CAMPHOR (NATURAL); SILVER; GOLD; COPPER; EUCALYPTUS GLOBULUS LEAF",
"StrengthNumber": "4; 4; 4; 12; 12; 12; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150602",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1114-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1114-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1114-08",
"ProductNDC": "62106-1114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 15",
"NonProprietaryName": "Allium Cepa, Aurum Metallicum, Eucalyptus Globulus, Inula Helenium, Trigonella Foenum-graecum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150525",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "ONION; GOLD; EUCALYPTUS GLOBULUS LEAF; INULA HELENIUM ROOT; FENUGREEK SEED",
"StrengthNumber": "4; 12; 4; 4; 4",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150525",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1115-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1115-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1115-08",
"ProductNDC": "62106-1115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 16",
"NonProprietaryName": "Saxifraga Granulata, Origanum Vulgare, Lactuca Virosa, Veronica Officinalis, Ajuga Reptans, Drosera, Senega Officinalis, Aurum Metallicum, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150507",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "VERONICA OFFICINALIS FLOWERING TOP; AJUGA REPTANS WHOLE; DROSERA ROTUNDIFOLIA FLOWERING TOP; POLYGALA SENEGA ROOT; GOLD; SAXIFRAGA GRANULATA WHOLE; ORIGANUM VULGARE SUBSP. HIRTUM WHOLE; LACTUCA VIROSA; SILVER",
"StrengthNumber": "4; 4; 4; 4; 12; 4; 4; 4; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2021-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150507",
"SamplePackage": "N"
},
{
"NDCCode": "62106-1116-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1116-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1116-08",
"ProductNDC": "62106-1116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 17",
"NonProprietaryName": "Jateorhiza Palmata, Boldo Leaf, Rhamnus Frangula, Scabiosa Succisa Underground Parts, Valeriana Officinalis, Dulcamara, Rumex Crispus, Argentum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150206",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "JATEORHIZA CALUMBA ROOT; PEUMUS BOLDUS LEAF; FRANGULA ALNUS BARK; VALERIAN; CHAMAELIRIUM LUTEUM ROOT; SOLANUM DULCAMARA STEM; RUMEX CRISPUS ROOT; SILVER",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 4; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150206",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For the temporary relief of symptom sassociated with mild skin irritation. poor digestion. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "62106-1117-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1117-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1117-08",
"ProductNDC": "62106-1117",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 18",
"NonProprietaryName": "Condurango, Lycopodium Clavatum, Viburnum Prunifolium, Thuja Occidentalis, Camphora, Cuprum Metallicum, Aluminium Metallicum, Stibium Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150206",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "ANTIMONY; MARSDENIA CONDURANGO BARK; VIBURNUM PRUNIFOLIUM BARK; THUJA OCCIDENTALIS LEAFY TWIG; CINNAMOMUM CAMPHORA WHOLE; COPPER; LYCOPODIUM CLAVATUM SPORE; ALUMINUM",
"StrengthNumber": "12; 5; 5; 5; 9; 12; 5; 12",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]",
"Status": "Active",
"LastUpdate": "2022-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150206",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For the temporary relief of symptoms associated with low energy tiredness overall exhaustion. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily, or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "62106-1118-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1118-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1118-08",
"ProductNDC": "62106-1118",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unda 19",
"NonProprietaryName": "Aluminium Metallicum, Drosera, Illicium Verum, Mentha Piperita, Senega Officinalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170403",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "ALUMINUM; STAR ANISE FRUIT; POLYGALA SENEGA ROOT; DROSERA ROTUNDIFOLIA FLOWERING TOP; PEPPERMINT",
"StrengthNumber": "12; 3; 4; 5; 5",
"StrengthUnit": "[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170403",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For the temporary relief of symptoms associated with minor respiratory problems. Directions. Adults and adolescents (12 years and older) Take 5 drops three times daily or as. recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner."
},
{
"NDCCode": "62106-1119-8",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62106-1119-8) > 20 mL in 1 BOTTLE, GLASS",
"NDC11Code": "62106-1119-08",
"ProductNDC": "62106-1119",
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<IndicationAndUsage>Uses For the temporary relief of symptoms associated with indigestion lack of appetite stomach aches. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner.</IndicationAndUsage>
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<Description>OnabotulinumtoxinA is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying. The primary release procedure for BOTOX uses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to AbbVie’s products BOTOX and BOTOX Cosmetic. One Unit of BOTOX corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. Due to specific details of this assay such as the vehicle, dilution scheme, and laboratory protocols, Units of biological activity of BOTOX cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX is approximately 20 Units/nanogram of neurotoxin protein complex. Each vial of BOTOX (onabotulinumtoxinA) for injection contains either 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.</Description>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: 1 Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication (1.1), 2 Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication (1.1), 3 Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. (1.2), 4 Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer) (1.3), 5 Treatment of spasticity in patients 2 years of age and older (1.4), 6 Treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain (1.5) , 7 Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients (1.6), 8 Treatment of blepharospasm associated with dystonia in patients 12 years of age and older (1.7), 9 Treatment of strabismus in patients 12 years of age and older (1.7).</IndicationAndUsage>
<Description>OnabotulinumtoxinA is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying. The primary release procedure for BOTOX uses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to AbbVie’s products BOTOX and BOTOX Cosmetic. One Unit of BOTOX corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. Due to specific details of this assay such as the vehicle, dilution scheme, and laboratory protocols, Units of biological activity of BOTOX cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX is approximately 20 Units/nanogram of neurotoxin protein complex. Each vial of BOTOX (onabotulinumtoxinA) for injection contains either 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.</Description>
</NDC>
<NDC>
<NDCCode>0338-1145-03</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-1145-03) </PackageDescription>
<NDC11Code>00338-1145-03</NDC11Code>
<ProductNDC>0338-1145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix E</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970326</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020678</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE</SubstanceName>
<StrengthNumber>311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 297; 261; 51; 77; 33; 10</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0378-1145-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-1145-01) </PackageDescription>
<NDC11Code>00378-1145-01</NDC11Code>
<ProductNDC>0378-1145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076008</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets 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 have 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 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, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 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 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 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 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 are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Buspirone hydrochloride tablets are supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 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 and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg 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). A single 30 mg 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 contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>60219-1145-3</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (60219-1145-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>60219-1145-03</NDC11Code>
<ProductNDC>60219-1145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darunavir</ProprietaryName>
<NonProprietaryName>Darunavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212493</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>DARUNAVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Darunavir, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].</IndicationAndUsage>
<Description>Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. It has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester. Its molecular formula is C27H37N3O7S and its molecular weight is 547.66 g/mol. Darunavir has the following structural formula. Darunavir is a white to creamish solid. It is freely soluble in ethyl acetate and in dichloromethane; practically insoluble in water. Each darunavir tablet contains 600 mg or 800 mg of darunavir. It also contains the inactive ingredients: colloidal silicon dioxide, crospovidone Type A, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate Type A. The 600 mg tablet film-coating, OPADRY-II Orange, contains FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film-coating, OPADRY-II Brown, contains ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62106-1100-8</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62106-1100-8) > 20 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>62106-1100-08</NDC11Code>
<ProductNDC>62106-1100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 1</ProprietaryName>
<NonProprietaryName>Achillea Millefolium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>ACHILLEA MILLEFOLIUM; ARCTOSTAPHYLOS UVA-URSI LEAF; VALERIAN; ANGELICA ARCHANGELICA ROOT; EQUISETUM ARVENSE TOP; LYCOPODIUM CLAVATUM SPORE; LARIX DECIDUA RESIN; SILVER</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 4; 5; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptoms associated with indigestion fatigue following meals occasional headaches. Directions. Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1101-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1101-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1101-08</NDC11Code>
<ProductNDC>62106-1101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 2</ProprietaryName>
<NonProprietaryName>Petroselinum Sativum, Rhamnus Frangula, Thlaspi Bursa-pastoris, Juniperus Communis, Asparagus Officinalis, Berberis Vulgaris, Genista Tinctoria, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150526</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK; PETROSELINUM CRISPUM; ASPARAGUS; FRANGULA ALNUS BARK; CAPSELLA BURSA-PASTORIS; SILVER; GENISTA TINCTORIA; JUNIPER BERRY</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 12; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1102-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1102-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1102-08</NDC11Code>
<ProductNDC>62106-1102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 3</ProprietaryName>
<NonProprietaryName>Equisetum Arvense Stem, Chamomilla, Condurango Bark, Viola Tricolor, Boldo Leaf, Aluminium Metallicum, Stannum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>EQUISETUM ARVENSE TOP; MATRICARIA RECUTITA; MARSDENIA CONDURANGO BARK; VIOLA TRICOLOR; PEUMUS BOLDUS LEAF; ALUMINUM; TIN</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1103-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1103-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1103-08</NDC11Code>
<ProductNDC>62106-1103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 4</ProprietaryName>
<NonProprietaryName>Laurus Nobilis, Condurango, Rhamnus Frangula, Menyanthes Trifoliata, Absinthium, Jateorhiza Palmata, Argentum Metallicum, Antimonium Crudum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>FRANGULA ALNUS BARK; MENYANTHES TRIFOLIATA; WORMWOOD; JATEORHIZA CALUMBA ROOT; SILVER; ANTIMONY TRISULFIDE; BAY LEAF; MARSDENIA CONDURANGO BARK</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 12; 12; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</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>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1104-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1104-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1104-08</NDC11Code>
<ProductNDC>62106-1104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 5</ProprietaryName>
<NonProprietaryName>Tormentilla, Tussilago Farfara, Adiantum Capillus-veneris, Glycyrrhiza Glabra, Drosera, Grindelia, Inula Helenium, Cuprum Metallicum, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150602</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>POTENTILLA ERECTA ROOT; ADIANTUM CAPILLUS-VENERIS LEAF; DROSERA ROTUNDIFOLIA FLOWERING TOP; GLYCYRRHIZA GLABRA; GRINDELIA HIRSUTULA FLOWERING TOP; INULA HELENIUM ROOT; COPPER; SILVER; TUSSILAGO FARFARA WHOLE</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 4; 12; 12; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1105-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1105-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1105-08</NDC11Code>
<ProductNDC>62106-1105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 6</ProprietaryName>
<NonProprietaryName>Senna Leaflet, Rhamnus Frangula Bark, Carum Carvi, Foeniculum Vulgare, Illicium Verum, Rhamnus Cathartica, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150526</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>SENNA LEAF; FRANGULA ALNUS BARK; CARAWAY SEED; FENNEL SEED; ILLICIUM VERUM WHOLE; RHAMNUS CATHARTICA FRUIT; SILVER</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 4; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</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], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1106-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1106-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1106-08</NDC11Code>
<ProductNDC>62106-1106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 7</ProprietaryName>
<NonProprietaryName>Equisetum Arvense, Uva-ursi, Juniperus Communis, Cytisus Scoparius, Hieraciumpilosella, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>HIERACIUM PILOSELLA WHOLE; EQUISETUM ARVENSE TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; JUNIPERUS COMMUNIS WHOLE; CYTISUS SCOPARIUS FLOWERING TOP; SILVER</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1107-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1107-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1107-08</NDC11Code>
<ProductNDC>62106-1107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 8</ProprietaryName>
<NonProprietaryName>Hamamelis Virginiana, Millefolium, Equisetum Arvense, Mercurialis Perennis, Thlaspi Bursa-pastoris, Cactus Grandiflorus, Crataegus, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150602</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>HAMAMELIS VIRGINIANA BARK; MERCURIALIS PERENNIS; CRATAEGUS FRUIT; COPPER; ACHILLEA MILLEFOLIUM; EQUISETUM ARVENSE BRANCH; CAPSELLA BURSA-PASTORIS; SELENICEREUS GRANDIFLORUS STEM</SubstanceName>
<StrengthNumber>4; 4; 4; 12; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</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>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1108-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1108-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1108-08</NDC11Code>
<ProductNDC>62106-1108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 9</ProprietaryName>
<NonProprietaryName>Mentha Piperita, Melissa Officinalis, Salvia Pratensis, Thymus Vulgaris, Valeriana Officinalis, Aurum Metallicum, Plumbum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150527</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>GOLD; THYMUS VULGARIS WHOLE; VALERIAN; LEAD; MENTHA PIPERITA; SALVIA PRATENSIS LEAF; MELISSA OFFICINALIS</SubstanceName>
<StrengthNumber>12; 4; 4; 12; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1109-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1109-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1109-08</NDC11Code>
<ProductNDC>62106-1109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 10</ProprietaryName>
<NonProprietaryName>Absinthium, Argentum Metallicum, Equisetum Arvense, Juniperus Communis, Millefolium, Rhamnus Frangula</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150929</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>SILVER; EQUISETUM ARVENSE BRANCH; JUNIPER BERRY; WORMWOOD; ACHILLEA MILLEFOLIUM; FRANGULA ALNUS BARK</SubstanceName>
<StrengthNumber>12; 4; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [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>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1110-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1110-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1110-08</NDC11Code>
<ProductNDC>62106-1110</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 11</ProprietaryName>
<NonProprietaryName>Asparagus Officinalis Young Shoot, Mentha Piperita Whole Plant, Millefolium Whole Plant,thymus Serpyllum Whole Plant, Crocus Sativus Dried Stigma, Rosmarinus Officinalis Flowering Twigs, Glechoma Hederacea Whole Plant, Verbena Officinalis Whole Plant, Uva-ursi Leaf, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150224</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>VERBENA OFFICINALIS; COPPER; ASPARAGUS; GLECHOMA HEDERACEA; ARCTOSTAPHYLOS UVA-URSI LEAF; MENTHA PIPERITA; ACHILLEA MILLEFOLIUM; THYMUS SERPYLLUM; SAFFRON; ROSMARINUS OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>4; 12; 4; 4; 4; 4; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For the temporary relief of minor pain associated with headaches. joints. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years) Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1112-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (62106-1112-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1112-08</NDC11Code>
<ProductNDC>62106-1112</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 13</ProprietaryName>
<NonProprietaryName>Boldo Leaf, Ricinus Communis Seed, Combretum Raimbaultii Leaf, Jateorhiza Palmata Root, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141217</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>SILVER; PEUMUS BOLDUS LEAF; RICINUS COMMUNIS SEED; COMBRETUM MICRANTHUM LEAF; JATEORHIZA CALUMBA ROOT</SubstanceName>
<StrengthNumber>12; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptoms associated with digestive upset. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years) Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1113-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1113-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1113-08</NDC11Code>
<ProductNDC>62106-1113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 14</ProprietaryName>
<NonProprietaryName>Eucalyptus Globulus, Inula Helenium, Jateorhiza Palmata, Camphora, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150602</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>INULA HELENIUM ROOT; JATEORHIZA CALUMBA ROOT; CAMPHOR (NATURAL); SILVER; GOLD; COPPER; EUCALYPTUS GLOBULUS LEAF</SubstanceName>
<StrengthNumber>4; 4; 4; 12; 12; 12; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1114-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1114-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1114-08</NDC11Code>
<ProductNDC>62106-1114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 15</ProprietaryName>
<NonProprietaryName>Allium Cepa, Aurum Metallicum, Eucalyptus Globulus, Inula Helenium, Trigonella Foenum-graecum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150525</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>ONION; GOLD; EUCALYPTUS GLOBULUS LEAF; INULA HELENIUM ROOT; FENUGREEK SEED</SubstanceName>
<StrengthNumber>4; 12; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1115-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1115-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1115-08</NDC11Code>
<ProductNDC>62106-1115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 16</ProprietaryName>
<NonProprietaryName>Saxifraga Granulata, Origanum Vulgare, Lactuca Virosa, Veronica Officinalis, Ajuga Reptans, Drosera, Senega Officinalis, Aurum Metallicum, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>VERONICA OFFICINALIS FLOWERING TOP; AJUGA REPTANS WHOLE; DROSERA ROTUNDIFOLIA FLOWERING TOP; POLYGALA SENEGA ROOT; GOLD; SAXIFRAGA GRANULATA WHOLE; ORIGANUM VULGARE SUBSP. HIRTUM WHOLE; LACTUCA VIROSA; SILVER</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 12; 4; 4; 4; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1116-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1116-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1116-08</NDC11Code>
<ProductNDC>62106-1116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 17</ProprietaryName>
<NonProprietaryName>Jateorhiza Palmata, Boldo Leaf, Rhamnus Frangula, Scabiosa Succisa Underground Parts, Valeriana Officinalis, Dulcamara, Rumex Crispus, Argentum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150206</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>JATEORHIZA CALUMBA ROOT; PEUMUS BOLDUS LEAF; FRANGULA ALNUS BARK; VALERIAN; CHAMAELIRIUM LUTEUM ROOT; SOLANUM DULCAMARA STEM; RUMEX CRISPUS ROOT; SILVER</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 4; 4; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptom sassociated with mild skin irritation. poor digestion. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1117-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1117-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1117-08</NDC11Code>
<ProductNDC>62106-1117</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 18</ProprietaryName>
<NonProprietaryName>Condurango, Lycopodium Clavatum, Viburnum Prunifolium, Thuja Occidentalis, Camphora, Cuprum Metallicum, Aluminium Metallicum, Stibium Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150206</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>ANTIMONY; MARSDENIA CONDURANGO BARK; VIBURNUM PRUNIFOLIUM BARK; THUJA OCCIDENTALIS LEAFY TWIG; CINNAMOMUM CAMPHORA WHOLE; COPPER; LYCOPODIUM CLAVATUM SPORE; ALUMINUM</SubstanceName>
<StrengthNumber>12; 5; 5; 5; 9; 12; 5; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</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>2022-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptoms associated with low energy tiredness overall exhaustion. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily, or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1118-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1118-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1118-08</NDC11Code>
<ProductNDC>62106-1118</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 19</ProprietaryName>
<NonProprietaryName>Aluminium Metallicum, Drosera, Illicium Verum, Mentha Piperita, Senega Officinalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170403</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>ALUMINUM; STAR ANISE FRUIT; POLYGALA SENEGA ROOT; DROSERA ROTUNDIFOLIA FLOWERING TOP; PEPPERMINT</SubstanceName>
<StrengthNumber>12; 3; 4; 5; 5</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [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>2022-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptoms associated with minor respiratory problems. Directions. Adults and adolescents (12 years and older) Take 5 drops three times daily or as. recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1119-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1119-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1119-08</NDC11Code>
<ProductNDC>62106-1119</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 20</ProprietaryName>
<NonProprietaryName>Aluminium Metallicum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Calendula Officinalis, Condurango, Jacaranda Caroba, Robinia Pseudoacacia, Sabina</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150525</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>ALUMINUM; SILVER; ARSENIC TRIOXIDE; GOLD; CALENDULA OFFICINALIS FLOWERING TOP; MARSDENIA CONDURANGO BARK; JACARANDA CAROBA LEAF; ROBINIA PSEUDOACACIA BARK; JUNIPERUS SABINA LEAF</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 4; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1120-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1120-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1120-08</NDC11Code>
<ProductNDC>62106-1120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 21</ProprietaryName>
<NonProprietaryName>Condurango, Calendula Officinalis, Camphora, Hydrastis Canadensis, Thuja Occidentalis, Aluminium Metallicum, Aurum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150526</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>MARSDENIA CONDURANGO BARK; CALENDULA OFFICINALIS FLOWERING TOP; CAMPHOR (NATURAL); GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG; ALUMINUM; GOLD</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1121-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1121-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1121-08</NDC11Code>
<ProductNDC>62106-1121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 22</ProprietaryName>
<NonProprietaryName>Absinthium, Aconitum Napellus, Argentum Metallicum, Boldo Leaf, Chamomilla, Coffea Tosta, Jateorhiza Palmata, Manganum Oxydatum Nigrum, Salvia Officinalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150921</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>MANGANESE DIOXIDE; SAGE; PEUMUS BOLDUS LEAF; MATRICARIA RECUTITA; JATEORHIZA CALUMBA ROOT; WORMWOOD; ACONITUM NAPELLUS; SILVER; COFFEA ARABICA SEED, ROASTED</SubstanceName>
<StrengthNumber>12; 4; 4; 4; 4; 4; 4; 12; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</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>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62106-1122-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1122-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1122-08</NDC11Code>
<ProductNDC>62106-1122</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 23</ProprietaryName>
<NonProprietaryName>Equisetum Arvense, Hypericum Perforatum, Nux Vomica, Quercus Robur, Tormentilla,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151214</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>STRYCHNOS NUX-VOMICA SEED; QUERCUS ROBUR TWIG BARK; EQUISETUM ARVENSE BRANCH; HYPERICUM PERFORATUM; POTENTILLA ERECTA ROOT</SubstanceName>
<StrengthNumber>6; 6; 5; 5; 6</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptoms associated with occasional incontinence minor urinary discomfort. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1123-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1123-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1123-08</NDC11Code>
<ProductNDC>62106-1123</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 24</ProprietaryName>
<NonProprietaryName>Crataegus Fruit, Passiflora Incarnata, Boldo Leaf, Valeriana Officinalis Root, Chamomilla, Aluminium Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150224</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>PEUMUS BOLDUS LEAF; CRATAEGUS FRUIT; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; MATRICARIA RECUTITA; ALUMINUM</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 12</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of symptoms associated with mild digestive upset. Directions Adults and adolescents (12 years and older). Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years). Take under the direction of your healthcare practitioner.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62106-1124-8</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62106-1124-8) > 20 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62106-1124-08</NDC11Code>
<ProductNDC>62106-1124</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Unda 25</ProprietaryName>
<NonProprietaryName>Argentum Metallicum, Crataegus, Gelsemium Sempervirens, Hamamelis Virginiana, Magnolia Grandiflora, Spiraea Ulmaria, Stannum Metallicum, Valeriana Officinalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150921</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>SILVER; FILIPENDULA ULMARIA ROOT; CRATAEGUS FRUIT; TIN; VALERIAN; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA BARK; MAGNOLIA GRANDIFLORA FLOWER</SubstanceName>
<StrengthNumber>12; 4; 4; 12; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>