{
"NDC": [
{
"NDCCode": "69676-0009-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69676-0009-2) > 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "69676-0009-02",
"ProductNDC": "69676-0009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramp Rx",
"NonProprietaryName": "Angustura Vera, Belladonna, Berberis Vulgaris, Colchicum Autumnale, Colocynthis, Ignatia Amara, Jatropha Curcas, Lycopodium Clavatum, Nux Moshchata, Rhus Toxicodendron, Secale Cornutum, Veratrum Album",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20181024",
"EndMarketingDate": "20230630",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa Inc.",
"SubstanceName": "ANGOSTURA BARK; BERBERIS VULGARIS ROOT BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; COLCHICUM AUTUMNALE BULB; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA; NUTMEG; STRYCHNOS IGNATII SEED; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT",
"StrengthNumber": "12; 6; 12; 12; 12; 12; 6; 6; 6; 12; 12; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181024",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "N"
},
{
"NDCCode": "69676-0006-3",
"PackageDescription": "2 TABLET, CHEWABLE in 1 POUCH (69676-0006-3) ",
"NDC11Code": "69676-0006-03",
"ProductNDC": "69676-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold Crush Adult",
"NonProprietaryName": "Aconitum Napellus, Allium Cepa, Bryonia Alba, Euphrasia Officinalis, Gelsemium Sempervirens, Nux Vomica, Pulsatilla, Rhus Toxicodendron, Sabadilla",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180711",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa Inc.",
"SubstanceName": "PULSATILLA PRATENSIS; GELSEMIUM SEMPERVIRENS ROOT; ONION; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; TOXICODENDRON PUBESCENS SHOOT; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED",
"StrengthNumber": "6; 12; 6; 6; 12; 6; 12; 12; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180711",
"SamplePackage": "Y",
"IndicationAndUsage": "Uses*. addresses symptoms associated with the common cold, such as: 1 chest congestion, 2 nasal congestion, 3 runny nose, 4 cough, 5 sore throat, 6 sneezing."
},
{
"NDCCode": "69676-0007-3",
"PackageDescription": "2 TABLET, CHEWABLE in 1 POUCH (69676-0007-3) ",
"NDC11Code": "69676-0007-03",
"ProductNDC": "69676-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stress Relief",
"NonProprietaryName": "Aconitum Napellus, Calcarea Carbonica, Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Passiflora Incarnata, Valeriana Officinalis",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180703",
"EndMarketingDate": "20230731",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa Inc.",
"SubstanceName": "ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; VALERIAN",
"StrengthNumber": "12; 12; 12; 8; 3; 12; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180703",
"EndMarketingDatePackage": "20210930",
"SamplePackage": "Y"
},
{
"NDCCode": "69676-0011-2",
"PackageDescription": "40 [hp_X] in 1 BLISTER PACK (69676-0011-2)",
"NDC11Code": "69676-0011-02",
"ProductNDC": "69676-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps",
"NonProprietaryName": "Angustra Vera, Belladonna, Berbris Vulgaris, Colchicum Autumnale, Colocynthis, Ignatia Amara, Jatropha Curcas, Lycopodium Clavatum, Nux Moschata, Rhus Toxicodendron, Secale, Veratrum Album",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150824",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa LLC",
"SubstanceName": "ANGOSTURA BARK; BELLADONNA LEAF; COLCHICUM AUTUMNALE WHOLE; CITRULLUS COLOCYNTHIS WHOLE; STRYCHNOS IGNATII WHOLE; JATROPHA CURCAS WHOLE; LYCOPODIUM CLAVATUM WHOLE; NUTMEG; RHUS SPP. WHOLE; SECALE CEREALE WHOLE; VERATRUM ALBUM WHOLE; BERBERIS VULGARIS WHOLE",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 6; 6; 12; 12; 12; 6",
"StrengthUnit": "[hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]",
"Status": "Deprecated",
"LastUpdate": "2016-03-11"
},
{
"NDCCode": "69676-0012-3",
"PackageDescription": "2 TABLET, CHEWABLE in 1 POUCH (69676-0012-3) ",
"NDC11Code": "69676-0012-03",
"ProductNDC": "69676-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleepology",
"NonProprietaryName": "Alfalfa, Avena Sativa, Chamomilla, Eschscholtzia Californica, Gelsemium Sempervirens, Nux Moschata, Passiflora Incarnata, Piper Methysticum, Valeriana Officinalis",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa Inc.",
"SubstanceName": "AVENA SATIVA FLOWERING TOP; ALFALFA; ESCHSCHOLZIA CALIFORNICA; PASSIFLORA INCARNATA FLOWERING TOP; NUTMEG; VALERIAN; PIPER METHYSTICUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA CHAMOMILLA WHOLE",
"StrengthNumber": "6; 6; 6; 6; 9; 6; 6; 12; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171030",
"SamplePackage": "Y",
"IndicationAndUsage": "Uses*. addresses sleeplessness and/or restless sleep."
},
{
"NDCCode": "69676-0013-2",
"PackageDescription": "40 [hp_X] in 1 BLISTER PACK (69676-0013-2)",
"NDC11Code": "69676-0013-02",
"ProductNDC": "69676-0013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Pain Relief",
"NonProprietaryName": "Arnica Montana, Calendula Officinalis, Ledum Palustre, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150824",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa LLC",
"SubstanceName": "RHUS SPP. WHOLE; ARNICA MONTANA; CALENDULA OFFICINALIS WHOLE; LEDUM PALUSTRE WHOLE; RUTA GRAVEOLENS WHOLE",
"StrengthNumber": "12; 30; 6; 6; 6",
"StrengthUnit": "[hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]",
"Status": "Deprecated",
"LastUpdate": "2016-03-11"
},
{
"NDCCode": "69676-0014-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69676-0014-2) > 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "69676-0014-02",
"ProductNDC": "69676-0014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramp Rx",
"NonProprietaryName": "Angustura Vera, Belladonna, Berberis Vulgaris, Colchicum Autumnale, Colocynthis, Ignatia Amara, Jatropha Curcas, Lycopodium Clavatum, Nux Moshchata, Rhus Toxicodendron, Secale Cornutum, Veratrum Album",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"EndMarketingDate": "20200430",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa LLC",
"SubstanceName": "ATROPA BELLADONNA WHOLE; ANGOSTURA BARK; BERBERIS VULGARIS ROOT BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; STRYCHNOS IGNATII SEED; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; NUTMEG; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM; VERATRUM ALBUM ROOT; COLCHICUM AUTUMNALE BULB",
"StrengthNumber": "12; 12; 6; 12; 12; 12; 6; 6; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160321",
"EndMarketingDatePackage": "20200430",
"SamplePackage": "N"
},
{
"NDCCode": "69676-0015-2",
"PackageDescription": "40 [hp_X] in 1 PACKAGE (69676-0015-2)",
"NDC11Code": "69676-0015-02",
"ProductNDC": "69676-0015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coldcrush (kids)",
"NonProprietaryName": "Allium Cepa, Chamomilla, Eupatorium Perfoliatum, Echinacea Angustifolia, Kali Bichromicum, Senega Officinalis, Zincum Gluconicum",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150506",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa LLC",
"SubstanceName": "ALLIUM CEPA WHOLE; MATRICARIA CHAMOMILLA WHOLE; EUPATORIUM PERFOLIATUM WHOLE; ECHINACEA ANGUSTIFOLIA; CHROMIC CHLORIDE; POLYGALA SENEGA WHOLE; ZINC GLUCONATE",
"StrengthNumber": "6; 6; 6; 10; 6; 6; 10",
"StrengthUnit": "[hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]",
"Status": "Deprecated",
"LastUpdate": "2016-03-11"
},
{
"NDCCode": "69676-0022-3",
"PackageDescription": "2 TABLET, CHEWABLE in 1 POUCH (69676-0022-3) ",
"NDC11Code": "69676-0022-03",
"ProductNDC": "69676-0022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stress Relief",
"NonProprietaryName": "Aconitum Napellus, Calcarea Carbonica, Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Passiflora Incarnata, Valeriana Officinalis",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"EndMarketingDate": "20200531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa LLC",
"SubstanceName": "STRYCHNOS NUX-VOMICA SEED; VALERIAN; ACONITUM NAPELLUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYCOPODIUM CLAVATUM SPORE; PASSIFLORA INCARNATA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT",
"StrengthNumber": "12; 3; 12; 6; 12; 3; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171030",
"EndMarketingDatePackage": "20200531",
"SamplePackage": "Y"
},
{
"NDCCode": "69676-0024-3",
"PackageDescription": "2 TABLET, CHEWABLE in 1 POUCH (69676-0024-3) ",
"NDC11Code": "69676-0024-03",
"ProductNDC": "69676-0024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold Crush Adult",
"NonProprietaryName": "Allium Cepa, Belladonna, Bryonia Alba, Euphrasia Officinalis, Gelsemium Sempervirens, Nux Vomica, Pulsatilla Nigrans, Rhus Toxicodendron, Sabadilla",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"EndMarketingDate": "20200430",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa LLC",
"SubstanceName": "GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA PRATENSIS; ONION; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; TOXICODENDRON PUBESCENS SHOOT; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED",
"StrengthNumber": "12; 6; 6; 12; 12; 6; 12; 12; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171030",
"EndMarketingDatePackage": "20200430",
"SamplePackage": "Y"
},
{
"NDCCode": "69676-0031-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69676-0031-2) > 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "69676-0031-02",
"ProductNDC": "69676-0031",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Advantage",
"NonProprietaryName": "Arnica Montana, Calendula Officinalis, Ledum Palustre, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"EndMarketingDate": "20231031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa Inc.",
"SubstanceName": "ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "30; 6; 6; 6; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160321",
"EndMarketingDatePackage": "20231031",
"SamplePackage": "N"
},
{
"NDCCode": "69676-0044-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69676-0044-2) / 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "69676-0044-02",
"ProductNDC": "69676-0044",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Genexa Arnica Pain",
"NonProprietaryName": "Arnica Montana, Calendula Officinalis, Ledum Palustre, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20201220",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa Inc.",
"SubstanceName": "TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "12; 30; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201220",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*: 1 addresses muscle pain and stiffness due to minor injuries, overexertion and falls., 2 addresses pain, swelling and discoloration from bruises."
},
{
"NDCCode": "69676-0045-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69676-0045-2) > 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "69676-0045-02",
"ProductNDC": "69676-0045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Genexa Leg Cramps",
"NonProprietaryName": "Angustura Vera, Berberis Vulgaris, Chamomilla, Colchicum Autumnale, Colocynthis, Ignatia Amara, Jatropha Curcas, Lycopodium Clavatum, Nux Moshchata, Rhus Toxicodendron, Secale Cornutum, Veratrum Album",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa Inc.",
"SubstanceName": "ANGOSTURA BARK; BERBERIS VULGARIS ROOT BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; COLCHICUM AUTUMNALE BULB; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA; NUTMEG; STRYCHNOS IGNATII SEED; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT",
"StrengthNumber": "12; 6; 12; 12; 12; 12; 6; 6; 6; 12; 12; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. addresses stiffness, pain in limbs, joints, and legs, and cramps in calves, feet and legs."
},
{
"NDCCode": "69676-0048-3",
"PackageDescription": "2 TABLET, CHEWABLE in 1 POUCH (69676-0048-3) ",
"NDC11Code": "69676-0048-03",
"ProductNDC": "69676-0048",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Genexa Stress",
"NonProprietaryName": "Aconitum Napellus, Calcarea Carbonica, Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Passiflora Incarnata, Valeriana Officinalis",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20210107",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Genexa Inc.",
"SubstanceName": "STRYCHNOS NUX-VOMICA SEED; VALERIAN; ACONITUM NAPELLUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYCOPODIUM CLAVATUM SPORE; PASSIFLORA INCARNATA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT",
"StrengthNumber": "12; 3; 12; 8; 12; 3; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221208",
"SamplePackage": "Y",
"IndicationAndUsage": "Uses*. address symptoms associated with stress, such as: 1 fatigue, 2 nervousness, 3 anxiousness, 4 irritability, 5 hypersensitivity."
},
{
"NDCCode": "69676-0052-3",
"PackageDescription": "2 TABLET, CHEWABLE in 1 POUCH (69676-0052-3) ",
"NDC11Code": "69676-0052-03",
"ProductNDC": "69676-0052",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Genexa Allergy Care",
"NonProprietaryName": "Allium Cepa, Ambrosia Artemisiifolia, Arundo Mauritanica, Dulcamara, Euphrasia Officinalis, Nux Vomica, Pulsatilla, Ranunculus Bulbosus, Sabadilla, Sinapis Nigra, Sticta Pulmonaria, Wyethia Helenoides",
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{
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{
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<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<EndMarketingDatePackage>20200430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69676-0015-2</NDCCode>
<PackageDescription>40 [hp_X] in 1 PACKAGE (69676-0015-2)</PackageDescription>
<NDC11Code>69676-0015-02</NDC11Code>
<ProductNDC>69676-0015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coldcrush (kids)</ProprietaryName>
<NonProprietaryName>Allium Cepa, Chamomilla, Eupatorium Perfoliatum, Echinacea Angustifolia, Kali Bichromicum, Senega Officinalis, Zincum Gluconicum</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150506</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Genexa LLC</LabelerName>
<SubstanceName>ALLIUM CEPA WHOLE; MATRICARIA CHAMOMILLA WHOLE; EUPATORIUM PERFOLIATUM WHOLE; ECHINACEA ANGUSTIFOLIA; CHROMIC CHLORIDE; POLYGALA SENEGA WHOLE; ZINC GLUCONATE</SubstanceName>
<StrengthNumber>6; 6; 6; 10; 6; 6; 10</StrengthNumber>
<StrengthUnit>[hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-03-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>69676-0022-3</NDCCode>
<PackageDescription>2 TABLET, CHEWABLE in 1 POUCH (69676-0022-3) </PackageDescription>
<NDC11Code>69676-0022-03</NDC11Code>
<ProductNDC>69676-0022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stress Relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Calcarea Carbonica, Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Passiflora Incarnata, Valeriana Officinalis</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<EndMarketingDate>20200531</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Genexa LLC</LabelerName>
<SubstanceName>STRYCHNOS NUX-VOMICA SEED; VALERIAN; ACONITUM NAPELLUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYCOPODIUM CLAVATUM SPORE; PASSIFLORA INCARNATA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT</SubstanceName>
<StrengthNumber>12; 3; 12; 6; 12; 3; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171030</StartMarketingDatePackage>
<EndMarketingDatePackage>20200531</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>69676-0024-3</NDCCode>
<PackageDescription>2 TABLET, CHEWABLE in 1 POUCH (69676-0024-3) </PackageDescription>
<NDC11Code>69676-0024-03</NDC11Code>
<ProductNDC>69676-0024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold Crush Adult</ProprietaryName>
<NonProprietaryName>Allium Cepa, Belladonna, Bryonia Alba, Euphrasia Officinalis, Gelsemium Sempervirens, Nux Vomica, Pulsatilla Nigrans, Rhus Toxicodendron, Sabadilla</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<EndMarketingDate>20200430</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Genexa LLC</LabelerName>
<SubstanceName>GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA PRATENSIS; ONION; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; TOXICODENDRON PUBESCENS SHOOT; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED</SubstanceName>
<StrengthNumber>12; 6; 6; 12; 12; 6; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171030</StartMarketingDatePackage>
<EndMarketingDatePackage>20200430</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>69676-0031-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69676-0031-2) > 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69676-0031-02</NDC11Code>
<ProductNDC>69676-0031</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica Advantage</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calendula Officinalis, Ledum Palustre, Rhus Toxicodendron, Ruta Graveolens</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<EndMarketingDate>20231031</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Genexa Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>30; 6; 6; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<EndMarketingDatePackage>20231031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69676-0044-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69676-0044-2) / 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69676-0044-02</NDC11Code>
<ProductNDC>69676-0044</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Genexa Arnica Pain</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calendula Officinalis, Ledum Palustre, Rhus Toxicodendron, Ruta Graveolens</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Genexa Inc.</LabelerName>
<SubstanceName>TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP</SubstanceName>
<StrengthNumber>12; 30; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses*: 1 addresses muscle pain and stiffness due to minor injuries, overexertion and falls., 2 addresses pain, swelling and discoloration from bruises.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69676-0045-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69676-0045-2) > 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69676-0045-02</NDC11Code>
<ProductNDC>69676-0045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Genexa Leg Cramps</ProprietaryName>
<NonProprietaryName>Angustura Vera, Berberis Vulgaris, Chamomilla, Colchicum Autumnale, Colocynthis, Ignatia Amara, Jatropha Curcas, Lycopodium Clavatum, Nux Moshchata, Rhus Toxicodendron, Secale Cornutum, Veratrum Album</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Genexa Inc.</LabelerName>
<SubstanceName>ANGOSTURA BARK; BERBERIS VULGARIS ROOT BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; COLCHICUM AUTUMNALE BULB; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA; NUTMEG; STRYCHNOS IGNATII SEED; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>12; 6; 12; 12; 12; 12; 6; 6; 6; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses*. addresses stiffness, pain in limbs, joints, and legs, and cramps in calves, feet and legs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69676-0048-3</NDCCode>
<PackageDescription>2 TABLET, CHEWABLE in 1 POUCH (69676-0048-3) </PackageDescription>
<NDC11Code>69676-0048-03</NDC11Code>
<ProductNDC>69676-0048</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Genexa Stress</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Calcarea Carbonica, Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Passiflora Incarnata, Valeriana Officinalis</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210107</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Genexa Inc.</LabelerName>
<SubstanceName>STRYCHNOS NUX-VOMICA SEED; VALERIAN; ACONITUM NAPELLUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYCOPODIUM CLAVATUM SPORE; PASSIFLORA INCARNATA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT</SubstanceName>
<StrengthNumber>12; 3; 12; 8; 12; 3; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221208</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Uses*. address symptoms associated with stress, such as: 1 fatigue, 2 nervousness, 3 anxiousness, 4 irritability, 5 hypersensitivity.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69676-0052-3</NDCCode>
<PackageDescription>2 TABLET, CHEWABLE in 1 POUCH (69676-0052-3) </PackageDescription>
<NDC11Code>69676-0052-03</NDC11Code>
<ProductNDC>69676-0052</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Genexa Allergy Care</ProprietaryName>
<NonProprietaryName>Allium Cepa, Ambrosia Artemisiifolia, Arundo Mauritanica, Dulcamara, Euphrasia Officinalis, Nux Vomica, Pulsatilla, Ranunculus Bulbosus, Sabadilla, Sinapis Nigra, Sticta Pulmonaria, Wyethia Helenoides</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Genexa Inc.</LabelerName>
<SubstanceName>AMBROSIA ARTEMISIIFOLIA; STRYCHNOS NUX-VOMICA SEED; BLACK MUSTARD SEED; LOBARIA PULMONARIA; ARUNDO PLINIANA ROOT; RANUNCULUS BULBOSUS WHOLE; PULSATILLA PRATENSIS; SCHOENOCAULON OFFICINALE SEED; SOLANUM DULCAMARA TOP; EUPHRASIA STRICTA; WYETHIA HELENIOIDES ROOT; ALLIUM CEPA WHOLE</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221208</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Uses*. addresses symptoms associated with hay fever or other upper respiratory allergies, such as: 1 sneezing , 2 runny nose, 3 itchy, watery eyes, 4 nasal congestion, 5 itchy nose & throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69676-0059-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69676-0059-2) / 100 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>69676-0059-02</NDC11Code>
<ProductNDC>69676-0059</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Genexa Acetaminophen</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Genexa Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to: the common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual cramps, 2 temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69676-0063-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69676-0063-2) / 100 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>69676-0063-02</NDC11Code>
<ProductNDC>69676-0063</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Genexa Acetaminophen Pm</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Genexa Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69676-0071-3</NDCCode>
<PackageDescription>2 TABLET, CHEWABLE in 1 POUCH (69676-0071-3) </PackageDescription>
<NDC11Code>69676-0071-03</NDC11Code>
<ProductNDC>69676-0071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy D</ProprietaryName>
<NonProprietaryName>Allium Cepa, Ambrosia Artemisiifolia, Arundo Mauritanica, Dulcamara, Euphrasia Officinalis, Nux Vomica, Pulsatilla, Ranunculus Bulbosus, Sabadilla, Sinapis Nigra, Sticta Pulmonaria, Wyethia Helenoides</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<EndMarketingDate>20230630</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Genexa Inc.</LabelerName>
<SubstanceName>AMBROSIA ARTEMISIIFOLIA; ARUNDO PLINIANA ROOT; BLACK MUSTARD SEED; EUPHRASIA STRICTA; LOBARIA PULMONARIA; ONION; PULSATILLA PRATENSIS; RANUNCULUS BULBOSUS; SCHOENOCAULON OFFICINALE SEED; SOLANUM DULCAMARA STEM; STRYCHNOS NUX-VOMICA SEED; WYETHIA HELENIOIDES ROOT</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<EndMarketingDatePackage>20220228</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>69676-0079-3</NDCCode>
<PackageDescription>2 BOTTLE in 1 KIT (69676-0079-3) / 1 KIT in 1 BOTTLE * 177 mL in 1 BOTTLE, PLASTIC (69676-0077-9) * 177 mL in 1 BOTTLE (69676-0094-9) </PackageDescription>
<NDC11Code>69676-0079-03</NDC11Code>
<ProductNDC>69676-0079</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, Acetaminophen, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240531</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Genexa Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69676-0089-9</NDCCode>
<PackageDescription>2 BOTTLE, PLASTIC in 1 CARTON (69676-0089-9) / 118 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69676-0089-09</NDC11Code>
<ProductNDC>69676-0089</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Pain And Fever</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250313</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Genexa Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>2 BOTTLE in 1 KIT (69676-0095-3) / 1 KIT in 1 BOTTLE * 177 mL in 1 BOTTLE (69676-0093-9) * 177 mL in 1 BOTTLE (69676-0094-9) </PackageDescription>
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<IndicationAndUsage>Uses. temporarily reduces fever and relieves minor aches and pains due to: 1 the common cold, 2 headache, 3 toothache, 4 flu, 5 sore throat.</IndicationAndUsage>
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<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
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<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
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<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
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<StartMarketingDate>19590402</StartMarketingDate>
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<ApplicationNumber>NDA011856</ApplicationNumber>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
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<LastUpdate>2025-12-17</LastUpdate>
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<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
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<PackageDescription>25 VIAL in 1 CARTON (0009-0047-26) / 2 mL in 1 VIAL (0009-0047-27) </PackageDescription>
<NDC11Code>00009-0047-26</NDC11Code>
<ProductNDC>0009-0047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-medrol</ProprietaryName>
<NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19590402</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011856</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19590402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
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