{
"NDC": [
{
"NDCCode": "58809-190-16",
"PackageDescription": "473 mL in 1 BOTTLE (58809-190-16) ",
"NDC11Code": "58809-0190-16",
"ProductNDC": "58809-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanacof 2",
"NonProprietaryName": "Chlophedianol Hcl, Dexchlorpheniramine Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20231214",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "DEXCHLORPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE",
"StrengthNumber": "1; 12.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231214",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:. ■ runny nose. ■ sneezing. ■ itching of the nose or throat. ■ itchy, watery eyes. ■ cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "58809-820-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (58809-820-16) ",
"NDC11Code": "58809-0820-16",
"ProductNDC": "58809-820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vanatol",
"ProprietaryNameSuffix": "Lq",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20150428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040387",
"LabelerName": "GM Pharmaceuticals",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2020-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150428",
"SamplePackage": "N"
},
{
"NDCCode": "43538-190-16",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (43538-190-16) > 454 g in 1 BOTTLE, PUMP",
"NDC11Code": "43538-0190-16",
"ProductNDC": "43538-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumadan Wash",
"NonProprietaryName": "Sulfacetamide Sodium And Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110710",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Medimetriks Pharmaceuticals Inc.",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "90; 45",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110710",
"SamplePackage": "N",
"IndicationAndUsage": "Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is. Each mL of Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: butylated hydroxytoluene, C12-15 alkyl benzoate, caprylyl glycol, cetyl alcohol, cholesterol, chrysanthemum dendranthema, dimethicone, disodium oleamido MIPA sulfosuccinate, edetate disodium, ethylene brassilate, glyceryl stearate, hexylene glycol, lemon oil, magnesium aluminum silicate, magnesium chloride, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, niacinamide, nonoxynol-20, octoxynol-5, purified water, PEG-100 stearate, phenoxyethanol, propylene glycol, sodium cocoyl isotheionite, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum."
},
{
"NDCCode": "43538-192-16",
"PackageDescription": "1 KIT in 1 CARTON (43538-192-16) * 454 g in 1 BOTTLE, PUMP (43538-190-16) * 85 g in 1 TUBE (43538-290-03) ",
"NDC11Code": "43538-0192-16",
"ProductNDC": "43538-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumadan Xlt",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur, Avobenzone, Octinoxate, And Octisalate",
"DosageFormName": "KIT",
"StartMarketingDate": "20131201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Medimetriks Pharmaceuticals Inc.",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20131201",
"SamplePackage": "N"
},
{
"NDCCode": "53041-190-16",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-190-16) ",
"NDC11Code": "53041-0190-16",
"ProductNDC": "53041-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief 600 Mg",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200624",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209215",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2024-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200624",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "54162-190-16",
"PackageDescription": "472 mL in 1 BOTTLE, PLASTIC (54162-190-16)",
"NDC11Code": "54162-0190-16",
"ProductNDC": "54162-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mineral Oil",
"NonProprietaryName": "Mineral Oil",
"DosageFormName": "OIL",
"RouteName": "ORAL",
"StartMarketingDate": "20150731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Geritrex LLC",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "471.9528",
"StrengthUnit": "g/472mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "For relief of occasional constipation (irregularity). generally produces bowel movement in 6 to 8 hours."
},
{
"NDCCode": "62559-190-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (62559-190-16) ",
"NDC11Code": "62559-0190-16",
"ProductNDC": "62559-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoclopramide",
"NonProprietaryName": "Metoclopramide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071402",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150518",
"SamplePackage": "N",
"IndicationAndUsage": "The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration.",
"Description": "Metoclopramide Oral Solution USP is an orange-colored, vanilla-flavored, palatable, aromatic, sugar-free liquid for oral administration. Each 5 mL (teaspoonful) contains: Metoclopramide base (as the monohydrochloride monohydrate) 5 mg. Inactive ingredients: Citric Acid Anhydrous, FD&C Yellow No. 5 (tartrazine), FD&C Red No. 40, Glycerin, Methylparaben, Propylparaben, Purified Water, Sorbitol Solution 70%, Vanilla Flavor. Metoclopramide hydrochloride is a white, crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its molecular formula is C14H22ClN3O2HClH2O, with a molecular weight of 354.3. Its structural formula is."
},
{
"NDCCode": "65133-190-16",
"PackageDescription": "4 CARTRIDGE in 1 PACKAGE (65133-190-16) > 1000 mL in 1 CARTRIDGE (65133-190-08) ",
"NDC11Code": "65133-0190-16",
"ProductNDC": "65133-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aire-master",
"ProprietaryNameSuffix": "Foaming Ab Triclosan Free",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Aire-Master of America, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/10mL",
"Status": "Deprecated",
"LastUpdate": "2022-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N"
},
{
"NDCCode": "68382-190-16",
"PackageDescription": "90 TABLET in 1 BOTTLE (68382-190-16) ",
"NDC11Code": "68382-0190-16",
"ProductNDC": "68382-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Candesartan Cilexetil",
"NonProprietaryName": "Candesartan Cilexetil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091390",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "CANDESARTAN CILEXETIL",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180222",
"SamplePackage": "N",
"IndicationAndUsage": "Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1)., 2 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2).",
"Description": "Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its molecular formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil, USP is a white to almost white powder with a molecular weight of 610.67. It is practically insoluble in water, soluble in methylene chloride and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Each candesartan cilexetil tablet, USP intended for oral administration contains 4 mg or 8 mg or 16 mg or 32 mg candesartan cilexetil. In addition each tablet contains the following inactive ingredients: carboxymethyl cellulose calcium, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and polyethylene glycol. Additionally each 4 mg and 8 mg tablet contains ferric oxide red."
},
{
"NDCCode": "71160-190-16",
"PackageDescription": "480 mL in 1 BOTTLE (71160-190-16) ",
"NDC11Code": "71160-0190-16",
"ProductNDC": "71160-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Free Antibacterial Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Tekweld Solutions, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N"
},
{
"NDCCode": "58809-189-08",
"PackageDescription": "237 mL in 1 BOTTLE (58809-189-08) ",
"NDC11Code": "58809-0189-08",
"ProductNDC": "58809-189",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanacof Cp Allergy / Cough",
"NonProprietaryName": "Chlophedianol Hcl, Pyrilamine Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20231206",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "12.5; 25",
"StrengthUnit": "mg/15mL; mg/15mL",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231206",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies: ■ runny nose ■ itching of the nose or throat ■ sneezing ■ itchy, watery eyes ■ cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "58809-213-01",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (58809-213-01) ",
"NDC11Code": "58809-0213-01",
"ProductNDC": "58809-213",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear All Season Allergy Relief",
"NonProprietaryName": "Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "HOLCUS LANATUS POLLEN; MORUS RUBRA POLLEN; PINUS STROBUS POLLEN; NASTURTIUM OFFICINALE; AMARANTHUS SPINOSUS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; QUERCUS RUBRA POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; URTICA DIOICA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX CRISPUS POLLEN; SECALE CEREALE POLLEN; TAXODIUM DISTICHUM POLLEN; XANTHIUM STRUMARIUM POLLEN; QUERCUS NIGRA POLLEN; QUERCUS STELLATA POLLEN; SOLIDAGO CANADENSIS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA CONFERTIFLORA POLLEN; EUCALYPTUS GLOBULUS POLLEN; MYRRH; SALSOLA KALI POLLEN; QUERCUS MACROCARPA POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; ZEA MAYS POLLEN; CHENOPODIUM ALBUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; GOLDENSEAL; FAGUS GRANDIFOLIA POLLEN; FRAXINUS VELUTINA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; PINUS ECHINATA POLLEN; URTICA URENS WHOLE; AMARANTHUS PALMERI POLLEN; AMARANTHUS TUBERCULATUS POLLEN; CARYA ILLINOINENSIS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA POLLEN; HESPEROCYPARIS ARIZONICA POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; OLEA EUROPAEA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; ACER SACCHARUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AVENA SATIVA POLLEN; PHYTOLACCA AMERICANA ROOT; BAPTISIA TINCTORIA ROOT; ACER NEGUNDO POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA VULGARIS POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; JUNIPERUS ASHEI POLLEN; LIGUSTRUM VULGARE POLLEN; MYRICA CERIFERA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SCHINUS MOLLE POLLEN; ACACIA DEALBATA POLLEN; ATRIPLEX WRIGHTII POLLEN; PASPALUM NOTATUM POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; QUERCUS GAMBELII POLLEN; PLANTAGO LANCEOLATA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA BIDENTATA POLLEN; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; DISTICHLIS SPICATA POLLEN; EUPATORIUM CAPILLIFOLIUM POLLEN",
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"LastUpdate": "2025-12-16",
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},
{
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"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (58809-213-02) ",
"NDC11Code": "58809-0213-02",
"ProductNDC": "58809-213",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear All Season Allergy Relief",
"NonProprietaryName": "Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
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},
{
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"NDC11Code": "58809-0214-01",
"ProductNDC": "58809-214",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Texas Allergy Relief Plus Cedar Fever",
"NonProprietaryName": "Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
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"LastUpdate": "2025-12-16",
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},
{
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"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (58809-214-02) ",
"NDC11Code": "58809-0214-02",
"ProductNDC": "58809-214",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Texas Allergy Relief Plus Cedar Fever",
"NonProprietaryName": "Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
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},
{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Texas Allergy Relief Plus Cedar Fever",
"NonProprietaryName": "Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens",
"DosageFormName": "SOLUTION/ DROPS",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
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"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]",
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"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20231110",
"SamplePackage": "N",
"IndicationAndUsage": "This product is a homeopathic dilution, formulated to support the body's immunity for the temporary relief of allergies.*."
},
{
"NDCCode": "58809-215-90",
"PackageDescription": "90 min in 1 BOTTLE (58809-215-90) ",
"NDC11Code": "58809-0215-90",
"ProductNDC": "58809-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Texas Allergy Relief Plus Cedar Fever",
"NonProprietaryName": "Antigens All Zones Grasses, Trees, And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20231110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "SOLIDAGO CANADENSIS POLLEN; PHYTOLACCA AMERICANA ROOT; AMBROSIA ARTEMISIIFOLIA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; PINUS ECHINATA POLLEN; SORGHUM HALEPENSE POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; OLEA EUROPAEA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; ARTEMISIA VULGARIS POLLEN; POPULUS NIGRA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; QUERCUS RUBRA POLLEN; SECALE CEREALE POLLEN; CARYA OVATA POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS TUBERCULATUS POLLEN; RUMEX CRISPUS POLLEN; CELTIS OCCIDENTALIS POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; AMBROSIA ACANTHICARPA POLLEN; CHENOPODIUM ALBUM POLLEN; BAPTISIA TINCTORIA ROOT; TAXODIUM DISTICHUM POLLEN; JUGLANS NIGRA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; MYRRH; ULMUS AMERICANA POLLEN; GOLDENSEAL; EUPATORIUM CAPILLIFOLIUM POLLEN; PROSOPIS JULIFLORA POLLEN; MORUS ALBA POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; FRAXINUS AMERICANA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; URTICA DIOICA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS STROBUS POLLEN; AMBROSIA BIDENTATA POLLEN; ARTEMISIA TRIDENTATA POLLEN; XANTHIUM STRUMARIUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; BETULA NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; ACER SACCHARUM POLLEN; EUCALYPTUS GLOBULUS POLLEN; MYRICA CERIFERA POLLEN; SCHINUS MOLLE POLLEN; BASSIA SCOPARIA POLLEN; POA PRATENSIS POLLEN; QUERCUS VIRGINIANA POLLEN; JUNIPERUS ASHEI POLLEN; MELALEUCA QUINQUENERVIA POLLEN; QUERCUS GAMBELII POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; LIGUSTRUM VULGARE POLLEN; AMBROSIA TRIFIDA POLLEN; MORUS RUBRA POLLEN; SALSOLA KALI POLLEN; ATRIPLEX WRIGHTII POLLEN; DISTICHLIS SPICATA POLLEN; AMARANTHUS SPINOSUS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; HOLCUS LANATUS POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; URTICA URENS WHOLE; HESPEROCYPARIS ARIZONICA POLLEN; PASPALUM NOTATUM POLLEN; FAGUS GRANDIFOLIA POLLEN; ACER NEGUNDO POLLEN; AMARANTHUS PALMERI POLLEN; AVENA SATIVA POLLEN; ACACIA DEALBATA POLLEN; FRAXINUS VELUTINA POLLEN; ZEA MAYS POLLEN; TRITICUM AESTIVUM POLLEN; NASTURTIUM OFFICINALE",
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"PackageNdcExcludeFlag": "N",
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{
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"PackageDescription": "237 mL in 1 BOTTLE (58809-216-08) ",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Kids Daytime Cough And Chest Congestion",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20231025",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "GM Pharmaceuticals, INC",
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"StrengthUnit": "mg/15mL; mg/15mL",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
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},
{
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"PackageDescription": "473 mL in 1 BOTTLE (58809-999-01) ",
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"StartMarketingDatePackage": "20080422",
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},
{
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"PackageDescription": "12 BOTTLE in 1 TRAY (58809-999-02) / 15 mL in 1 BOTTLE",
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"PackageNdcExcludeFlag": "N",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
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"LabelerName": "Prime Packaging, Inc.",
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"StrengthUnit": "mg/mL; mg/mL; mg/mL",
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"LastUpdate": "2022-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200505",
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},
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"ProductNDC": "13630-0251",
"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "Prime Packaging, Inc.",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
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"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200505",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 Helps prevent sunburn., 2 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
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"StrengthUnit": "g/mL; g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-27",
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"StartMarketingDatePackage": "20200505",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 Helps prevent sunburn., 2 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "30142-190-05",
"PackageDescription": "3 CONTAINER in 1 CARTON (30142-190-05) / 24 LOZENGE in 1 CONTAINER (30142-190-03) ",
"NDC11Code": "30142-0190-05",
"ProductNDC": "30142-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20100914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090711",
"LabelerName": "Kroger Company",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100914",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "30142-190-06",
"PackageDescription": "4 CONTAINER in 1 CARTON (30142-190-06) > 24 LOZENGE in 1 CONTAINER",
"NDC11Code": "30142-0190-06",
"ProductNDC": "30142-190",
"ProductTypeName": "HUMAN OTC DRUG",
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"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20100914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090711",
"LabelerName": "Kroger Company",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160727",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "33332-219-20",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (33332-219-20) > .25 mL in 1 SYRINGE, GLASS (33332-219-21) ",
"NDC11Code": "33332-0219-20",
"ProductNDC": "33332-219",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Afluria Quadrivalent",
"NonProprietaryName": "Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/kansas/14/2017 X-327 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20190702",
"EndMarketingDate": "20200731",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125254",
"LabelerName": "Seqirus Pty Ltd.",
"SubstanceName": "INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)",
"StrengthNumber": "7.5; 7.5; 7.5; 7.5",
"StrengthUnit": "ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190702",
"EndMarketingDatePackage": "20200731",
"SamplePackage": "N"
},
{
"NDCCode": "33332-319-01",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (33332-319-01) > .5 mL in 1 SYRINGE, GLASS (33332-319-02) ",
"NDC11Code": "33332-0319-01",
"ProductNDC": "33332-319",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Afluria Quadrivalent",
"NonProprietaryName": "Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/kansas/14/2017 X-327 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20160928",
"EndMarketingDate": "20200731",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125254",
"LabelerName": "Seqirus Pty Ltd.",
"SubstanceName": "INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)",
"StrengthNumber": "15; 15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160928",
"EndMarketingDatePackage": "20200731",
"SamplePackage": "N"
},
{
"NDCCode": "33332-419-10",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (33332-419-10) > 5 mL in 1 VIAL, MULTI-DOSE (33332-419-11) ",
"NDC11Code": "33332-0419-10",
"ProductNDC": "33332-419",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Afluria Quadrivalent",
"NonProprietaryName": "Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/kansas/14/2017 X-327 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20170816",
"EndMarketingDate": "20200731",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125254",
"LabelerName": "Seqirus Pty Ltd.",
"SubstanceName": "INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)",
"StrengthNumber": "15; 15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170816",
"EndMarketingDatePackage": "20200731",
"SamplePackage": "N"
},
{
"NDCCode": "35573-459-60",
"PackageDescription": "60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60) ",
"NDC11Code": "35573-0459-60",
"ProductNDC": "35573-459",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carglumic Acid",
"NonProprietaryName": "Carglumic Acid",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20221219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213395",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "CARGLUMIC ACID",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Carbamoyl Phosphate Synthetase 1 Activator [EPC], Carbamoyl Phosphate Synthetase 1 Activators [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221219",
"SamplePackage": "N",
"IndicationAndUsage": "Carglumic acid tablets for oral suspension is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as: 1 Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. (1.1), 2 Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. (1.1).",
"Description": "Carglumic acid tablets for oral suspension contain 200 mg of carglumic acid. Carglumic acid, the active substance, is a carbamoyl phosphate synthetase 1 (CPS 1) activator and is soluble in dimethyl formamide and sparingly soluble in water. The chemical name of carglumic acid is N-carbamoyl-L-glutamic acid or (2S)-2-(carbamoylamino) pentanedioic acid. The empirical formula is C6H10N2O5 and the molecular weight is 190.16. The structural formula is. The inactive ingredients of carglumic acid tablets for oral suspension are croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate, colloidal silicon dioxide and sodium stearyl fumarate."
},
{
"NDCCode": "37000-190-80",
"PackageDescription": "80 g in 1 CYLINDER (37000-190-80) ",
"NDC11Code": "37000-0190-80",
"ProductNDC": "37000-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gillette Endurance Power Beads Cool Wave Clear",
"NonProprietaryName": "Aluminum Zirconium Octachlorohydrex Gly",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141220",
"EndMarketingDate": "20221003",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY",
"StrengthNumber": "16",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141220",
"EndMarketingDatePackage": "20221003",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
<NDCCode>58809-190-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (58809-190-16) </PackageDescription>
<NDC11Code>58809-0190-16</NDC11Code>
<ProductNDC>58809-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanacof 2</ProprietaryName>
<NonProprietaryName>Chlophedianol Hcl, Dexchlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>DEXCHLORPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1; 12.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:. ■ runny nose. ■ sneezing. ■ itching of the nose or throat. ■ itchy, watery eyes. ■ cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-820-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (58809-820-16) </PackageDescription>
<NDC11Code>58809-0820-16</NDC11Code>
<ProductNDC>58809-820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vanatol</ProprietaryName>
<ProprietaryNameSuffix>Lq</ProprietaryNameSuffix>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040387</ApplicationNumber>
<LabelerName>GM Pharmaceuticals</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43538-190-16</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (43538-190-16) > 454 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>43538-0190-16</NDC11Code>
<ProductNDC>43538-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumadan Wash</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium And Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110710</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Medimetriks Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>90; 45</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is. Each mL of Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: butylated hydroxytoluene, C12-15 alkyl benzoate, caprylyl glycol, cetyl alcohol, cholesterol, chrysanthemum dendranthema, dimethicone, disodium oleamido MIPA sulfosuccinate, edetate disodium, ethylene brassilate, glyceryl stearate, hexylene glycol, lemon oil, magnesium aluminum silicate, magnesium chloride, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, niacinamide, nonoxynol-20, octoxynol-5, purified water, PEG-100 stearate, phenoxyethanol, propylene glycol, sodium cocoyl isotheionite, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>43538-192-16</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (43538-192-16) * 454 g in 1 BOTTLE, PUMP (43538-190-16) * 85 g in 1 TUBE (43538-290-03) </PackageDescription>
<NDC11Code>43538-0192-16</NDC11Code>
<ProductNDC>43538-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumadan Xlt</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur, Avobenzone, Octinoxate, And Octisalate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20131201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Medimetriks Pharmaceuticals Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53041-190-16</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (53041-190-16) </PackageDescription>
<NDC11Code>53041-0190-16</NDC11Code>
<ProductNDC>53041-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief 600 Mg</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200624</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209215</ApplicationNumber>
<LabelerName>Guardian Drug Company</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54162-190-16</NDCCode>
<PackageDescription>472 mL in 1 BOTTLE, PLASTIC (54162-190-16)</PackageDescription>
<NDC11Code>54162-0190-16</NDC11Code>
<ProductNDC>54162-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mineral Oil</ProprietaryName>
<NonProprietaryName>Mineral Oil</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Geritrex LLC</LabelerName>
<SubstanceName>MINERAL OIL</SubstanceName>
<StrengthNumber>471.9528</StrengthNumber>
<StrengthUnit>g/472mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For relief of occasional constipation (irregularity). generally produces bowel movement in 6 to 8 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62559-190-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (62559-190-16) </PackageDescription>
<NDC11Code>62559-0190-16</NDC11Code>
<ProductNDC>62559-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071402</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration.</IndicationAndUsage>
<Description>Metoclopramide Oral Solution USP is an orange-colored, vanilla-flavored, palatable, aromatic, sugar-free liquid for oral administration. Each 5 mL (teaspoonful) contains: Metoclopramide base (as the monohydrochloride monohydrate) 5 mg. Inactive ingredients: Citric Acid Anhydrous, FD&C Yellow No. 5 (tartrazine), FD&C Red No. 40, Glycerin, Methylparaben, Propylparaben, Purified Water, Sorbitol Solution 70%, Vanilla Flavor. Metoclopramide hydrochloride is a white, crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its molecular formula is C14H22ClN3O2HClH2O, with a molecular weight of 354.3. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>65133-190-16</NDCCode>
<PackageDescription>4 CARTRIDGE in 1 PACKAGE (65133-190-16) > 1000 mL in 1 CARTRIDGE (65133-190-08) </PackageDescription>
<NDC11Code>65133-0190-16</NDC11Code>
<ProductNDC>65133-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aire-master</ProprietaryName>
<ProprietaryNameSuffix>Foaming Ab Triclosan Free</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Aire-Master of America, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-190-16</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68382-190-16) </PackageDescription>
<NDC11Code>68382-0190-16</NDC11Code>
<ProductNDC>68382-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Candesartan Cilexetil</ProprietaryName>
<NonProprietaryName>Candesartan Cilexetil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091390</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CANDESARTAN CILEXETIL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1)., 2 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2).</IndicationAndUsage>
<Description>Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its molecular formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil, USP is a white to almost white powder with a molecular weight of 610.67. It is practically insoluble in water, soluble in methylene chloride and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Each candesartan cilexetil tablet, USP intended for oral administration contains 4 mg or 8 mg or 16 mg or 32 mg candesartan cilexetil. In addition each tablet contains the following inactive ingredients: carboxymethyl cellulose calcium, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and polyethylene glycol. Additionally each 4 mg and 8 mg tablet contains ferric oxide red.</Description>
</NDC>
<NDC>
<NDCCode>71160-190-16</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (71160-190-16) </PackageDescription>
<NDC11Code>71160-0190-16</NDC11Code>
<ProductNDC>71160-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Free Antibacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Tekweld Solutions, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58809-189-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (58809-189-08) </PackageDescription>
<NDC11Code>58809-0189-08</NDC11Code>
<ProductNDC>58809-189</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanacof Cp Allergy / Cough</ProprietaryName>
<NonProprietaryName>Chlophedianol Hcl, Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>12.5; 25</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies: ■ runny nose ■ itching of the nose or throat ■ sneezing ■ itchy, watery eyes ■ cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-213-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (58809-213-01) </PackageDescription>
<NDC11Code>58809-0213-01</NDC11Code>
<ProductNDC>58809-213</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear All Season Allergy Relief</ProprietaryName>
<NonProprietaryName>Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20231110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>HOLCUS LANATUS POLLEN; MORUS RUBRA POLLEN; PINUS STROBUS POLLEN; NASTURTIUM OFFICINALE; AMARANTHUS SPINOSUS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; QUERCUS RUBRA POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; URTICA DIOICA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX CRISPUS POLLEN; SECALE CEREALE POLLEN; TAXODIUM DISTICHUM POLLEN; XANTHIUM STRUMARIUM POLLEN; QUERCUS NIGRA POLLEN; QUERCUS STELLATA POLLEN; SOLIDAGO CANADENSIS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA CONFERTIFLORA POLLEN; EUCALYPTUS GLOBULUS POLLEN; MYRRH; SALSOLA KALI POLLEN; QUERCUS MACROCARPA POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; ZEA MAYS POLLEN; CHENOPODIUM ALBUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; GOLDENSEAL; FAGUS GRANDIFOLIA POLLEN; FRAXINUS VELUTINA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; PINUS ECHINATA POLLEN; URTICA URENS WHOLE; AMARANTHUS PALMERI POLLEN; AMARANTHUS TUBERCULATUS POLLEN; CARYA ILLINOINENSIS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA POLLEN; HESPEROCYPARIS ARIZONICA POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; OLEA EUROPAEA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; ACER SACCHARUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AVENA SATIVA POLLEN; PHYTOLACCA AMERICANA ROOT; BAPTISIA TINCTORIA ROOT; ACER NEGUNDO POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA VULGARIS POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; JUNIPERUS ASHEI POLLEN; LIGUSTRUM VULGARE POLLEN; MYRICA CERIFERA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SCHINUS MOLLE POLLEN; ACACIA DEALBATA POLLEN; ATRIPLEX WRIGHTII POLLEN; PASPALUM NOTATUM POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; QUERCUS GAMBELII POLLEN; PLANTAGO LANCEOLATA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA BIDENTATA POLLEN; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; DISTICHLIS SPICATA POLLEN; EUPATORIUM CAPILLIFOLIUM POLLEN</SubstanceName>
<StrengthNumber>6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is a homeopathic dilution, formulated to support the body's immunity for the temporary relief of allergies.*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-213-02</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (58809-213-02) </PackageDescription>
<NDC11Code>58809-0213-02</NDC11Code>
<ProductNDC>58809-213</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear All Season Allergy Relief</ProprietaryName>
<NonProprietaryName>Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20231110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>HOLCUS LANATUS POLLEN; MORUS RUBRA POLLEN; PINUS STROBUS POLLEN; NASTURTIUM OFFICINALE; AMARANTHUS SPINOSUS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; QUERCUS RUBRA POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; URTICA DIOICA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX CRISPUS POLLEN; SECALE CEREALE POLLEN; TAXODIUM DISTICHUM POLLEN; XANTHIUM STRUMARIUM POLLEN; QUERCUS NIGRA POLLEN; QUERCUS STELLATA POLLEN; SOLIDAGO CANADENSIS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA CONFERTIFLORA POLLEN; EUCALYPTUS GLOBULUS POLLEN; MYRRH; SALSOLA KALI POLLEN; QUERCUS MACROCARPA POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; ZEA MAYS POLLEN; CHENOPODIUM ALBUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; GOLDENSEAL; FAGUS GRANDIFOLIA POLLEN; FRAXINUS VELUTINA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; PINUS ECHINATA POLLEN; URTICA URENS WHOLE; AMARANTHUS PALMERI POLLEN; AMARANTHUS TUBERCULATUS POLLEN; CARYA ILLINOINENSIS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA POLLEN; HESPEROCYPARIS ARIZONICA POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; OLEA EUROPAEA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; ACER SACCHARUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AVENA SATIVA POLLEN; PHYTOLACCA AMERICANA ROOT; BAPTISIA TINCTORIA ROOT; ACER NEGUNDO POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA VULGARIS POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; JUNIPERUS ASHEI POLLEN; LIGUSTRUM VULGARE POLLEN; MYRICA CERIFERA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SCHINUS MOLLE POLLEN; ACACIA DEALBATA POLLEN; ATRIPLEX WRIGHTII POLLEN; PASPALUM NOTATUM POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; QUERCUS GAMBELII POLLEN; PLANTAGO LANCEOLATA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA BIDENTATA POLLEN; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; DISTICHLIS SPICATA POLLEN; EUPATORIUM CAPILLIFOLIUM POLLEN</SubstanceName>
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<LastUpdate>2025-12-16</LastUpdate>
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<ProprietaryName>Texaclear Texas Allergy Relief Plus Cedar Fever</ProprietaryName>
<NonProprietaryName>Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens</NonProprietaryName>
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<LastUpdate>2025-12-16</LastUpdate>
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</NDC>
<NDC>
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<NonProprietaryName>Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens</NonProprietaryName>
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<LastUpdate>2025-12-16</LastUpdate>
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<ProprietaryName>Texaclear Texas Allergy Relief Plus Cedar Fever</ProprietaryName>
<NonProprietaryName>Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens</NonProprietaryName>
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<LastUpdate>2025-12-16</LastUpdate>
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<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
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<PackageDescription>90 min in 1 BOTTLE (58809-215-90) </PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Texas Allergy Relief Plus Cedar Fever</ProprietaryName>
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<DosageFormName>TABLET, CHEWABLE</DosageFormName>
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<StrengthNumber>6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 5; 5; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5</StrengthNumber>
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<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is a homeopathic dilution, formulated to support the body's immunity for the temporary relief of allergies.*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-216-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (58809-216-08) </PackageDescription>
<NDC11Code>58809-0216-08</NDC11Code>
<ProductNDC>58809-216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Kids Daytime Cough And Chest Congestion</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231025</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>5; 100</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: the intensity of coughingcough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-999-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (58809-999-01) </PackageDescription>
<NDC11Code>58809-0999-01</NDC11Code>
<ProductNDC>58809-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanacof</ProprietaryName>
<NonProprietaryName>Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080422</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 1; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nosesneezingitching of the nose or throatitchy, watery eyesnasal congestionreduces swelling of nasal passages. cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-999-02</NDCCode>
<PackageDescription>12 BOTTLE in 1 TRAY (58809-999-02) / 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58809-0999-02</NDC11Code>
<ProductNDC>58809-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanacof</ProprietaryName>
<NonProprietaryName>Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080422</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 1; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nosesneezingitching of the nose or throatitchy, watery eyesnasal congestionreduces swelling of nasal passages. cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13630-0193-4</NDCCode>
<PackageDescription>190 mL in 1 CAN (13630-0193-4) </PackageDescription>
<NDC11Code>13630-0193-04</NDC11Code>
<ProductNDC>13630-0193</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hurley</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf15</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200505</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Packaging, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>16.5; 41.2; 16.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13630-0251-4</NDCCode>
<PackageDescription>190 mL in 1 CAN (13630-0251-4) </PackageDescription>
<NDC11Code>13630-0251-04</NDC11Code>
<ProductNDC>13630-0251</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hurley</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf15</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200505</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Packaging, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>16.4; 41.1; 16.4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 Helps prevent sunburn., 2 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13630-0253-4</NDCCode>
<PackageDescription>190 mL in 1 CAN (13630-0253-4) </PackageDescription>
<NDC11Code>13630-0253-04</NDC11Code>
<ProductNDC>13630-0253</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hurley</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf15</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200505</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Prime Packaging, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>16.44; 41.1; 16.44</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 Helps prevent sunburn., 2 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-190-05</NDCCode>
<PackageDescription>3 CONTAINER in 1 CARTON (30142-190-05) / 24 LOZENGE in 1 CONTAINER (30142-190-03) </PackageDescription>
<NDC11Code>30142-0190-05</NDC11Code>
<ProductNDC>30142-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090711</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-190-06</NDCCode>
<PackageDescription>4 CONTAINER in 1 CARTON (30142-190-06) > 24 LOZENGE in 1 CONTAINER</PackageDescription>
<NDC11Code>30142-0190-06</NDC11Code>
<ProductNDC>30142-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090711</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33332-219-20</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (33332-219-20) > .25 mL in 1 SYRINGE, GLASS (33332-219-21) </PackageDescription>
<NDC11Code>33332-0219-20</NDC11Code>
<ProductNDC>33332-219</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Afluria Quadrivalent</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/kansas/14/2017 X-327 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20190702</StartMarketingDate>
<EndMarketingDate>20200731</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125254</ApplicationNumber>
<LabelerName>Seqirus Pty Ltd.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)</SubstanceName>
<StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
<StrengthUnit>ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190702</StartMarketingDatePackage>
<EndMarketingDatePackage>20200731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>33332-319-01</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (33332-319-01) > .5 mL in 1 SYRINGE, GLASS (33332-319-02) </PackageDescription>
<NDC11Code>33332-0319-01</NDC11Code>
<ProductNDC>33332-319</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Afluria Quadrivalent</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/kansas/14/2017 X-327 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20160928</StartMarketingDate>
<EndMarketingDate>20200731</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125254</ApplicationNumber>
<LabelerName>Seqirus Pty Ltd.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160928</StartMarketingDatePackage>
<EndMarketingDatePackage>20200731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>33332-419-10</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (33332-419-10) > 5 mL in 1 VIAL, MULTI-DOSE (33332-419-11) </PackageDescription>
<NDC11Code>33332-0419-10</NDC11Code>
<ProductNDC>33332-419</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Afluria Quadrivalent</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/kansas/14/2017 X-327 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20170816</StartMarketingDate>
<EndMarketingDate>20200731</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125254</ApplicationNumber>
<LabelerName>Seqirus Pty Ltd.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170816</StartMarketingDatePackage>
<EndMarketingDatePackage>20200731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>35573-459-60</NDCCode>
<PackageDescription>60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60) </PackageDescription>
<NDC11Code>35573-0459-60</NDC11Code>
<ProductNDC>35573-459</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carglumic Acid</ProprietaryName>
<NonProprietaryName>Carglumic Acid</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213395</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CARGLUMIC ACID</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Carbamoyl Phosphate Synthetase 1 Activator [EPC], Carbamoyl Phosphate Synthetase 1 Activators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carglumic acid tablets for oral suspension is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as: 1 Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. (1.1), 2 Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. (1.1).</IndicationAndUsage>
<Description>Carglumic acid tablets for oral suspension contain 200 mg of carglumic acid. Carglumic acid, the active substance, is a carbamoyl phosphate synthetase 1 (CPS 1) activator and is soluble in dimethyl formamide and sparingly soluble in water. The chemical name of carglumic acid is N-carbamoyl-L-glutamic acid or (2S)-2-(carbamoylamino) pentanedioic acid. The empirical formula is C6H10N2O5 and the molecular weight is 190.16. The structural formula is. The inactive ingredients of carglumic acid tablets for oral suspension are croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate, colloidal silicon dioxide and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>37000-190-80</NDCCode>
<PackageDescription>80 g in 1 CYLINDER (37000-190-80) </PackageDescription>
<NDC11Code>37000-0190-80</NDC11Code>
<ProductNDC>37000-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gillette Endurance Power Beads Cool Wave Clear</ProprietaryName>
<NonProprietaryName>Aluminum Zirconium Octachlorohydrex Gly</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141220</StartMarketingDate>
<EndMarketingDate>20221003</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141220</StartMarketingDatePackage>
<EndMarketingDatePackage>20221003</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>