{
"NDC": [
{
"NDCCode": "61626-0105-4",
"PackageDescription": "59 mL in 1 BOTTLE (61626-0105-4) ",
"NDC11Code": "61626-0105-04",
"ProductNDC": "61626-0105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wood",
"NonProprietaryName": "Belladonna, Berber Vulg, Carduus Mar, Chelidonium Maj, Cholesterinum, Colocynthis, Kali Carb, Nat Phos, Nitricum Ac, Nux Vom, Platinum Met, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; CHOLESTEROL; CITRULLUS COLOCYNTHIS FRUIT PULP; POTASSIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PLATINUM; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "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": "2021-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: For temporary relief of the neuro-emotional (autonomic nervous system - non phychiatric) disorders of anger, resentment and related emotions. Temporary relief of headache symptoms. Billousness, eye - minor eye irritation, tears, muscle, neck, weak spine and lower extremity disorders.**."
},
{
"NDCCode": "61626-0098-4",
"PackageDescription": "59 mL in 1 BOTTLE (61626-0098-4) ",
"NDC11Code": "61626-0098-04",
"ProductNDC": "61626-0098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flu Immune",
"NonProprietaryName": "Anas Barbarie Hepatis Et Cordis Extractum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/59mL",
"Status": "Active",
"LastUpdate": "2021-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: For the temporary relief of flu-related symptoms such as aches, pains, fever and chills. Flu Immune can be used at the onset of flu-like symptoms and as preventative. Flu Immune helps stimulate the body's immunity and is reccommended as first line of defense against flu-like symptoms. **."
},
{
"NDCCode": "61626-0099-4",
"PackageDescription": "59 mL in 1 BOTTLE (61626-0099-4) ",
"NDC11Code": "61626-0099-04",
"ProductNDC": "61626-0099",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pain Relief",
"NonProprietaryName": "Arnica, Chamomilla, Hypericum, Ignatia, Symphytum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "ARNICA MONTANA; MATRICARIA CHAMOMILLA; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; COMFREY ROOT",
"StrengthNumber": "12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2021-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: For the temporary relief of general pain, includingm symptoms related to joints, bones, muscles, minor bruises, spinal pain and pain due to arthiritis. **."
},
{
"NDCCode": "61626-0100-4",
"PackageDescription": "59 mL in 1 BOTTLE (61626-0100-4) ",
"NDC11Code": "61626-0100-04",
"ProductNDC": "61626-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Day And Night Vitals",
"NonProprietaryName": "Allium Sat, Aloe, Arsenicum Alb, Berber Vulg, Calc Phos, Ceanothus, Chelidonium Maj, Cholesterinum, Clematis Erecta, Condurango, Gambogia, Hamamelis, Kali Brom, Kali Phos, Lycopodium, Nat Carb, Passiflora, Senna, Silicea, Solidago, Spigelia Anth, Spongia, Veratrum Vir",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "GARLIC; ALOE VERA LEAF; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; TRIBASIC CALCIUM PHOSPHATE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHOLESTEROL; CLEMATIS RECTA FLOWERING TOP; MARSDENIA CONDURANGO BARK; GAMBOGE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; POTASSIUM BROMIDE; DIBASIC POTASSIUM PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; PASSIFLORA INCARNATA TOP; SENNA LEAF; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SPIGELIA ANTHELMIA; SPONGIA OFFICINALIS SKELETON, ROASTED; VERATRUM VIRIDE ROOT",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: For the temporary relief of symptoms related to low vitality and function of the Large intestine, Stomach, Spleen, Heart, Small Intestine, Bladder, Kidney, Sex Organs, Thyroid, Adrenal, Gall Bladder, Liver and Lung.**."
},
{
"NDCCode": "61626-0101-4",
"PackageDescription": "59 mL in 1 BOTTLE (61626-0101-4) ",
"NDC11Code": "61626-0101-04",
"ProductNDC": "61626-0101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yin-yang Balance",
"NonProprietaryName": "Adamas, Agaricus Musc, Agnus, Aletris, Angelica Sin, Arg Nit, Arnica, Avena, Baryta, Graphites, Kali Brom, Kreosotum, Lycopodium, Ocimum Sanc, Phosphoricum Ac, Selenium, Sepia, Thuja Occ.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "DIAMOND; AMANITA MUSCARIA FRUITING BODY; CHASTE TREE; ALETRIS FARINOSA ROOT; ANGELICA SINENSIS ROOT; SILVER NITRATE; ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; BARIUM IODIDE; GRAPHITE; POTASSIUM BROMIDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; OCIMUM TENUIFLORUM TOP; PHOSPHORIC ACID; SELENIUM; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2021-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: For the temporary relief of hormonal disbalance in men and women.**."
},
{
"NDCCode": "61626-0102-4",
"PackageDescription": "59 mL in 1 BOTTLE (61626-0102-4) ",
"NDC11Code": "61626-0102-04",
"ProductNDC": "61626-0102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Earth",
"NonProprietaryName": "Aur Met, Arg Nit, Causticum, Cinchona, Condurango, Ceanothus, Euphrasia, Fucus, Gallicum Ac, Iris Vers, Net Carb, Nitricum Ac, Phosphorus.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "GOLD; SILVER NITRATE; CAUSTICUM; CINCHONA OFFICINALIS BARK; MARSDENIA CONDURANGO BARK; CEANOTHUS AMERICANUS LEAF; EUPHRASIA STRICTA; FUCUS VESICULOSUS; GALLIC ACID MONOHYDRATE; IRIS VERSICOLOR ROOT; SODIUM CARBONATE; NITRIC ACID; PHOSPHORUS",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE. For the temporary relief of the neuro-emotional (automatic nervous system - non psychiatric) disorders of oversympathy, low self esteem and related emotions. Sensory, spinal and extremity disorders. Relief of symptoms of colds, sinus problems. Digestive, mouth saliva, taste disorders. Weak spine and lower extremity disorders.**."
},
{
"NDCCode": "61626-0103-4",
"PackageDescription": "59 mL in 1 BOTTLE (61626-0103-4) ",
"NDC11Code": "61626-0103-04",
"ProductNDC": "61626-0103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Metal",
"NonProprietaryName": "Aluminia, Ammon Carb, Anacardium, Antimon Crud, Hydrastis, Ignatia, Mag Phos, Nat Mur, Nitricum Ac, Osmium, Paraffinum, Senna, Silicea, Spongia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "ALUMINUM OXIDE; AMMONIUM CARBONATE; ANACARDIUM OCCIDENTALE FRUIT; ANTIMONY TRISULFIDE; GOLDENSEAL; STRYCHNOS IGNATII SEED; MAGNESIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; NITRIC ACID; OSMIUM; PARAFFIN; SENNA LEAF; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2021-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE. For the temporary relief of the neuro-emotional (autonomic nervous system - non psychiatric) disorders of grief, dogmatically positioned, sadness, crying, and related emotions. Sensory, spinal and extremity disorders. Nose - smell, mucous. Constipation. Skin - dry, itching. Weak spine disorders.**."
},
{
"NDCCode": "61626-0104-4",
"PackageDescription": "59 mL in 1 BOTTLE (61626-0104-4) ",
"NDC11Code": "61626-0104-04",
"ProductNDC": "61626-0104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Water",
"NonProprietaryName": "Aconitum Nap, Arsenicum Alb, Borax, Calc Phos, Gelsenium, Lycopodium, Phosphoricum Ac, Picricum Ac, Plumb Met, Solidago",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "ACONITUM NAPELLUS; ARSENIC TRIOXIDE; SODIUM BORATE; TRIBASIC CALCIUM PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PICRIC ACID; LEAD; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2021-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: For the temporary relief of the neuro-emotional (autonomic nervous system - non psychiatric) disorders of fear, weak - paralyzed will, dread, and related emotions. Sensory, spinal and extremity disorders. Ear - earache, bone - occipital and neck pain, weak spine and lower extremity disorders.**."
},
{
"NDCCode": "61626-0106-4",
"PackageDescription": "59 mL in 1 BOTTLE (61626-0106-4) ",
"NDC11Code": "61626-0106-04",
"ProductNDC": "61626-0106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fire",
"NonProprietaryName": "Apil Mel, Baptisia, Baryta Carb, Hamamelis, Kali Brom, Kali Phos, Lachesis, Lilium, Petroleum, Phosphoricum Ac, Spigelia Anth, Sulphur, Veratrum Vir",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; POTASSIUM BROMIDE; DIBASIC POTASSIUM PHOSPHATE; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM BULB; KEROSENE; PHOSPHORIC ACID; SPIGELIA ANTHELMIA; SULFUR; VERATRUM VIRIDE ROOT",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: For temporary relief of the neuro-emotional (autonomic nervous system - non psychiatric) disorders of vulnerability, lost, and related emotions. Minor circulation irregularities, fatigue. Tongue, perspiration, spine, and upper extremity disorders. Temporary relief of chest congestion and minor pain in reproductive organs.**."
},
{
"NDCCode": "61626-0107-4",
"PackageDescription": "59 mL in 1 BOTTLE (61626-0107-4) ",
"NDC11Code": "61626-0107-04",
"ProductNDC": "61626-0107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Para Solve",
"NonProprietaryName": "Calc Carb, Chenopodium Anth, Cina, Croton, Filix Mas, Gambocia, Granatum, Lycopodium, Merc Corros, Nat Phos, Santoninum, Senna, Spigelia Anth, Stannum Met, Tanacetum, Teuricum Mar, Zingiber",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; GAMBOGE; PUNICA GRANATUM ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SANTONIN; SENNA LEAF; SPIGELIA ANTHELMIA; TIN; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: For the temporary relief of gastrointestinal symptoms such as gas, bloating, stomach upset, abdominal discomfort which may be accompanied by pale face or circles under the eyes, bad breath, bariable appetite, localized ithching, postnasal drip, canker sores. irritability, back pain, resltess sleep, and sensitivity in lower right abdominal area. Temporary relief of cough.**."
},
{
"NDCCode": "61626-0108-4",
"PackageDescription": "59.1 mL in 1 BOTTLE (61626-0108-4) ",
"NDC11Code": "61626-0108-04",
"ProductNDC": "61626-0108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flora Plus",
"NonProprietaryName": "Aloe, Alumina, Antimon Crud, Arg Nit, Chelidonium Maj, Gambogia, Graphites, Hydrastis, Lycopodium, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "ALOE VERA LEAF; ALUMINUM OXIDE; ANTIMONY TRISULFIDE; SILVER NITRATE; CHELIDONIUM MAJUS; GAMBOGE; GRAPHITE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SILICON DIOXIDE",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL",
"Status": "Active",
"LastUpdate": "2021-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: For temporary relief of bowel congestions-constipation, gas, bloating Digestive disturbance and intestinal complaints from bread, acids, sour wines, fermentable foods-sweets-yeast White or yellow film on tongue Relief of symptoms associated with yeast infections Sensitivity in lower right abdominal area. **."
},
{
"NDCCode": "61626-0109-4",
"PackageDescription": "59.1 mL in 1 BOTTLE (61626-0109-4) ",
"NDC11Code": "61626-0109-04",
"ProductNDC": "61626-0109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allergy",
"NonProprietaryName": "Allium Sat, Anacardium, Apis Mel, Gambogia, Merc Solub, Nat Carb, Nitricum Ac, Nux Vom, Phosphorus, Pulsatilla, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Net Remedies",
"SubstanceName": "GARLIC; ANACARDIUM OCCIDENTALE FRUIT; APIS MELLIFERA; GAMBOGE; MERCURIUS SOLUBILIS; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: For the temporary relief of allergic reactions from environmental agents, slight errors in diet or certain foods causing symptoms of sensitivity, mood changes, headaches, tiredness, sinus congestion, itchy or burning eyes, dyspepsia, bloating, gas, sensitivity in lower right abdominal area.**."
},
{
"NDCCode": "61626-0110-4",
"PackageDescription": "59.1 mL in 1 BOTTLE (61626-0110-4) ",
"NDC11Code": "61626-0110-04",
"ProductNDC": "61626-0110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Er 911",
"NonProprietaryName": "Aconitum Nap, Apis Mel, Arnica, Arsenicum Alb, Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Clematis Erecta, Ferrum Phos, Histaminum, Hypericum, Ignatia, Impatiens Glan Flos, Ornithogalum, Passiflora, Phosphorus, Prunus Cerasifera, Rhus Tox, Sulphur, Symphytum, Vertarum Alb",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Net Remedies",
"SubstanceName": "ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA CHAMOMILLA; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF; SULFUR; COMFREY ROOT; VERATRUM ALBUM ROOT",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: For the temporary relief of emotional, mental, or physical trauma, high pressure or stressful situations Symptomatic relief of nervous tension, stress, dread and fever. Temporary relief of cold and flu-like symptoms. Overexertion Strains Tearfulness Fearfulness Oversensitivity Minor nerve pain and burning Quieting effect on nervous system.**."
},
{
"NDCCode": "61626-0111-4",
"PackageDescription": "59.1 mL in 1 BOTTLE (61626-0111-4) ",
"NDC11Code": "61626-0111-04",
"ProductNDC": "61626-0111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scars-adhesions",
"NonProprietaryName": "Calc Fluor, Causticum, Graphites, Hydrofluoricum Ac, Lachesis, Plumb Met, Rhus Tox, Sepia, Silicea, Thiosinaminum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "CALCIUM FLUORIDE; CAUSTICUM; GRAPHITE; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LEAD; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; ALLYLTHIOUREA",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL",
"Status": "Active",
"LastUpdate": "2021-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: Helps absorption of scars-fibrous tissue adhesions For the temporary relief of itching of scars Feelins of spasm pressure and tightness sensation in internal organs, esophagus and stomach Colic type symptoms.**."
},
{
"NDCCode": "61626-0112-4",
"PackageDescription": "59 mL in 1 BOTTLE (61626-0112-4) ",
"NDC11Code": "61626-0112-04",
"ProductNDC": "61626-0112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visceral Polarity",
"NonProprietaryName": "Aconitum Nap, Arg Nit, Chininum Pur, Echinacea Purp, Plum Met, Sepia, Sulphuricum Ac",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NET Remedies",
"SubstanceName": "ACONITUM NAPELLUS; SILVER NITRATE; QUININE; ECHINACEA PURPUREA; FERRIC FERROCYANIDE; GELSEMIUM SEMPERVIRENS ROOT; HOPS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; LEAD; SEPIA OFFICINALIS JUICE; SULFURIC ACID",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Chelating Activity [MoA], Decorporation Agent [EPC], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181204",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS FOR USE: For the temporary relief of lack of general emotional, physical, or mental balance Minor nervous system tension, confusion, nervousness, fatigue Feelings of spasm pressure and tightness sensation in internal organs, esophagus and stomach Temporary relief of heartburn General tone of nervous and digestive systems.**."
},
{
"NDCCode": "11822-0105-4",
"PackageDescription": "1 BOTTLE in 1 CARTON (11822-0105-4) > 118 mL in 1 BOTTLE",
"NDC11Code": "11822-0105-04",
"ProductNDC": "11822-0105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Non Aspirin",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19970226",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-15"
},
{
"NDCCode": "13630-0105-4",
"PackageDescription": "177 mL in 1 CAN (13630-0105-4) ",
"NDC11Code": "13630-0105-04",
"ProductNDC": "13630-0105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Australian Gold",
"ProprietaryNameSuffix": "X-treme Sport Spf 30 C/s Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Prime Packaging Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "25.2; 63; 42; 23.1; 16.8",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160407",
"SamplePackage": "N"
},
{
"NDCCode": "15631-0105-4",
"PackageDescription": "2500 PELLET in 1 PACKAGE (15631-0105-4) ",
"NDC11Code": "15631-0105-04",
"ProductNDC": "15631-0105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cantharis",
"NonProprietaryName": "Cantharis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151006",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "LYTTA VESICATORIA",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/1",
"Status": "Active",
"LastUpdate": "2021-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "37662-0105-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-0105-4) ",
"NDC11Code": "37662-0105-04",
"ProductNDC": "37662-0105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Nitrica",
"NonProprietaryName": "Calcarea Nitrica",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220519",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CALCIUM NITRITE",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220519",
"SamplePackage": "N"
},
{
"NDCCode": "49288-0105-4",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0105-4)",
"NDC11Code": "49288-0105-04",
"ProductNDC": "49288-0105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cashew Nut Meat",
"NonProprietaryName": "Cashew Nut Meat",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "CASHEW",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "50332-0105-4",
"PackageDescription": "50 PACKET in 1 BOX, UNIT-DOSE (50332-0105-4) > 2 TABLET in 1 PACKET",
"NDC11Code": "50332-0105-04",
"ProductNDC": "50332-0105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Exaprin",
"NonProprietaryName": "Acetaminophen, Aspirin, Caffeine, Salicylamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870120",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "HART Health",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE; SALICYLAMIDE",
"StrengthNumber": "110; 162; 32.4; 152",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19870120",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves minor aches and pains due to: 1 headache, 2 backache, 3 muscular aches, 4 minor arthritis pain, 5 the common cold, 6 toothache, 7 menstrual cramps."
},
{
"NDCCode": "53104-0105-4",
"PackageDescription": "100 mL in 1 BOTTLE (53104-0105-4)",
"NDC11Code": "53104-0105-04",
"ProductNDC": "53104-0105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zidovudine",
"NonProprietaryName": "Zidovudine",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20080626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077981",
"LabelerName": "Cipla Ltd.",
"SubstanceName": "ZIDOVUDINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-04-24"
},
{
"NDCCode": "58443-0105-4",
"PackageDescription": "177 mL in 1 BOTTLE (58443-0105-4) ",
"NDC11Code": "58443-0105-04",
"ProductNDC": "58443-0105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Solmate",
"ProprietaryNameSuffix": "Broad Spectrum Spf 15",
"NonProprietaryName": "Avobenzone, Octisalate, And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130828",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Prime Enterprises, Inc.",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "19.86; 49.65; 18.3705",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130828",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Dictections), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "67938-0105-3",
"PackageDescription": "1 TUBE in 1 BOX (67938-0105-3) > 15 g in 1 TUBE (67938-0105-4)",
"NDC11Code": "67938-0105-03",
"ProductNDC": "67938-0105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eight Hour Cream Skin Protectant",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091103",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Elizabeth Arden, Inc",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "28.4",
"StrengthUnit": "g/50g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To Use: Apply liberally as often as necessary.",
"Description": "(On Box) Uses: Treats symptoms of: chapping, peeling or flaking due to minor burns, sunburn, windburn, scrapes, abrasions, cracked lips. (On Tube) Soothes minor skin irritations. Also for symptoms of chapping, peeling or flaking due to minor burns, sunburn, windburn, scrapes, abrasions or cracked lips."
},
{
"NDCCode": "71335-0105-4",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0105-4) ",
"NDC11Code": "71335-0105-04",
"ProductNDC": "71335-0105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20130823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202366",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130823",
"SamplePackage": "N"
},
{
"NDCCode": "71858-0105-1",
"PackageDescription": "2 POUCH in 1 CARTON (71858-0105-1) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) ",
"NDC11Code": "71858-0105-01",
"ProductNDC": "71858-0105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"ProprietaryNameSuffix": "Sol",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206977",
"LabelerName": "IBSA Pharma Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "13",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190301",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "Y",
"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "71858-0105-2",
"PackageDescription": "6 POUCH in 1 CARTON (71858-0105-2) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) ",
"NDC11Code": "71858-0105-02",
"ProductNDC": "71858-0105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "IBSA Pharma Inc.",
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"StrengthUnit": "ug/mL",
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"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
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"PackageDescription": "6 POUCH in 1 CARTON (71858-0105-5) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "IBSA Pharma Inc.",
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"IndicationAndUsage": "TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .",
"Description": "TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water."
},
{
"NDCCode": "75318-0105-2",
"PackageDescription": "4 DRUM in 1 BOX (75318-0105-2) > 5 L in 1 DRUM (75318-0105-1) ",
"NDC11Code": "75318-0105-02",
"ProductNDC": "75318-0105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cela No-clean Hypochlorous Acid Disinfectant",
"NonProprietaryName": "Hypochlorous Acid Disinfectant",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20200424",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Shanghai Wanlay Environmental Protection Technology Co., Ltd.",
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{
"NDCCode": "0280-0105-01",
"PackageDescription": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-01) ",
"NDC11Code": "00280-0105-01",
"ProductNDC": "0280-0105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aleve Liquid Gels",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20231201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214463",
"LabelerName": "Bayer Healthcare LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-28",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to:, 2 minor pain of arthritis, 3 muscular aches, 4 backache, 5 menstrual cramps, 6 headache, 7 toothache, 8 the common cold, 9 temporarily reduces fever."
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NET Remedies</LabelerName>
<SubstanceName>GOLD; SILVER NITRATE; CAUSTICUM; CINCHONA OFFICINALIS BARK; MARSDENIA CONDURANGO BARK; CEANOTHUS AMERICANUS LEAF; EUPHRASIA STRICTA; FUCUS VESICULOSUS; GALLIC ACID MONOHYDRATE; IRIS VERSICOLOR ROOT; SODIUM CARBONATE; NITRIC ACID; PHOSPHORUS</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS FOR USE. For the temporary relief of the neuro-emotional (automatic nervous system - non psychiatric) disorders of oversympathy, low self esteem and related emotions. Sensory, spinal and extremity disorders. Relief of symptoms of colds, sinus problems. Digestive, mouth saliva, taste disorders. Weak spine and lower extremity disorders.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61626-0103-4</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (61626-0103-4) </PackageDescription>
<NDC11Code>61626-0103-04</NDC11Code>
<ProductNDC>61626-0103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Metal</ProprietaryName>
<NonProprietaryName>Aluminia, Ammon Carb, Anacardium, Antimon Crud, Hydrastis, Ignatia, Mag Phos, Nat Mur, Nitricum Ac, Osmium, Paraffinum, Senna, Silicea, Spongia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NET Remedies</LabelerName>
<SubstanceName>ALUMINUM OXIDE; AMMONIUM CARBONATE; ANACARDIUM OCCIDENTALE FRUIT; ANTIMONY TRISULFIDE; GOLDENSEAL; STRYCHNOS IGNATII SEED; MAGNESIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; NITRIC ACID; OSMIUM; PARAFFIN; SENNA LEAF; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS FOR USE. For the temporary relief of the neuro-emotional (autonomic nervous system - non psychiatric) disorders of grief, dogmatically positioned, sadness, crying, and related emotions. Sensory, spinal and extremity disorders. Nose - smell, mucous. Constipation. Skin - dry, itching. Weak spine disorders.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61626-0104-4</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (61626-0104-4) </PackageDescription>
<NDC11Code>61626-0104-04</NDC11Code>
<ProductNDC>61626-0104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Water</ProprietaryName>
<NonProprietaryName>Aconitum Nap, Arsenicum Alb, Borax, Calc Phos, Gelsenium, Lycopodium, Phosphoricum Ac, Picricum Ac, Plumb Met, Solidago</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NET Remedies</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARSENIC TRIOXIDE; SODIUM BORATE; TRIBASIC CALCIUM PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PICRIC ACID; LEAD; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS FOR USE: For the temporary relief of the neuro-emotional (autonomic nervous system - non psychiatric) disorders of fear, weak - paralyzed will, dread, and related emotions. Sensory, spinal and extremity disorders. Ear - earache, bone - occipital and neck pain, weak spine and lower extremity disorders.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61626-0106-4</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (61626-0106-4) </PackageDescription>
<NDC11Code>61626-0106-04</NDC11Code>
<ProductNDC>61626-0106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fire</ProprietaryName>
<NonProprietaryName>Apil Mel, Baptisia, Baryta Carb, Hamamelis, Kali Brom, Kali Phos, Lachesis, Lilium, Petroleum, Phosphoricum Ac, Spigelia Anth, Sulphur, Veratrum Vir</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NET Remedies</LabelerName>
<SubstanceName>APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; POTASSIUM BROMIDE; DIBASIC POTASSIUM PHOSPHATE; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM BULB; KEROSENE; PHOSPHORIC ACID; SPIGELIA ANTHELMIA; SULFUR; VERATRUM VIRIDE ROOT</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS FOR USE: For temporary relief of the neuro-emotional (autonomic nervous system - non psychiatric) disorders of vulnerability, lost, and related emotions. Minor circulation irregularities, fatigue. Tongue, perspiration, spine, and upper extremity disorders. Temporary relief of chest congestion and minor pain in reproductive organs.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61626-0107-4</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (61626-0107-4) </PackageDescription>
<NDC11Code>61626-0107-04</NDC11Code>
<ProductNDC>61626-0107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Para Solve</ProprietaryName>
<NonProprietaryName>Calc Carb, Chenopodium Anth, Cina, Croton, Filix Mas, Gambocia, Granatum, Lycopodium, Merc Corros, Nat Phos, Santoninum, Senna, Spigelia Anth, Stannum Met, Tanacetum, Teuricum Mar, Zingiber</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NET Remedies</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; GAMBOGE; PUNICA GRANATUM ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SANTONIN; SENNA LEAF; SPIGELIA ANTHELMIA; TIN; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS FOR USE: For the temporary relief of gastrointestinal symptoms such as gas, bloating, stomach upset, abdominal discomfort which may be accompanied by pale face or circles under the eyes, bad breath, bariable appetite, localized ithching, postnasal drip, canker sores. irritability, back pain, resltess sleep, and sensitivity in lower right abdominal area. Temporary relief of cough.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61626-0108-4</NDCCode>
<PackageDescription>59.1 mL in 1 BOTTLE (61626-0108-4) </PackageDescription>
<NDC11Code>61626-0108-04</NDC11Code>
<ProductNDC>61626-0108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flora Plus</ProprietaryName>
<NonProprietaryName>Aloe, Alumina, Antimon Crud, Arg Nit, Chelidonium Maj, Gambogia, Graphites, Hydrastis, Lycopodium, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NET Remedies</LabelerName>
<SubstanceName>ALOE VERA LEAF; ALUMINUM OXIDE; ANTIMONY TRISULFIDE; SILVER NITRATE; CHELIDONIUM MAJUS; GAMBOGE; GRAPHITE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS FOR USE: For temporary relief of bowel congestions-constipation, gas, bloating Digestive disturbance and intestinal complaints from bread, acids, sour wines, fermentable foods-sweets-yeast White or yellow film on tongue Relief of symptoms associated with yeast infections Sensitivity in lower right abdominal area. **.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61626-0109-4</NDCCode>
<PackageDescription>59.1 mL in 1 BOTTLE (61626-0109-4) </PackageDescription>
<NDC11Code>61626-0109-04</NDC11Code>
<ProductNDC>61626-0109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allergy</ProprietaryName>
<NonProprietaryName>Allium Sat, Anacardium, Apis Mel, Gambogia, Merc Solub, Nat Carb, Nitricum Ac, Nux Vom, Phosphorus, Pulsatilla, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Net Remedies</LabelerName>
<SubstanceName>GARLIC; ANACARDIUM OCCIDENTALE FRUIT; APIS MELLIFERA; GAMBOGE; MERCURIUS SOLUBILIS; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS FOR USE: For the temporary relief of allergic reactions from environmental agents, slight errors in diet or certain foods causing symptoms of sensitivity, mood changes, headaches, tiredness, sinus congestion, itchy or burning eyes, dyspepsia, bloating, gas, sensitivity in lower right abdominal area.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61626-0110-4</NDCCode>
<PackageDescription>59.1 mL in 1 BOTTLE (61626-0110-4) </PackageDescription>
<NDC11Code>61626-0110-04</NDC11Code>
<ProductNDC>61626-0110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Er 911</ProprietaryName>
<NonProprietaryName>Aconitum Nap, Apis Mel, Arnica, Arsenicum Alb, Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Clematis Erecta, Ferrum Phos, Histaminum, Hypericum, Ignatia, Impatiens Glan Flos, Ornithogalum, Passiflora, Phosphorus, Prunus Cerasifera, Rhus Tox, Sulphur, Symphytum, Vertarum Alb</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Net Remedies</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA CHAMOMILLA; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF; SULFUR; COMFREY ROOT; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS FOR USE: For the temporary relief of emotional, mental, or physical trauma, high pressure or stressful situations Symptomatic relief of nervous tension, stress, dread and fever. Temporary relief of cold and flu-like symptoms. Overexertion Strains Tearfulness Fearfulness Oversensitivity Minor nerve pain and burning Quieting effect on nervous system.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61626-0111-4</NDCCode>
<PackageDescription>59.1 mL in 1 BOTTLE (61626-0111-4) </PackageDescription>
<NDC11Code>61626-0111-04</NDC11Code>
<ProductNDC>61626-0111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scars-adhesions</ProprietaryName>
<NonProprietaryName>Calc Fluor, Causticum, Graphites, Hydrofluoricum Ac, Lachesis, Plumb Met, Rhus Tox, Sepia, Silicea, Thiosinaminum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NET Remedies</LabelerName>
<SubstanceName>CALCIUM FLUORIDE; CAUSTICUM; GRAPHITE; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LEAD; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; ALLYLTHIOUREA</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS FOR USE: Helps absorption of scars-fibrous tissue adhesions For the temporary relief of itching of scars Feelins of spasm pressure and tightness sensation in internal organs, esophagus and stomach Colic type symptoms.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61626-0112-4</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (61626-0112-4) </PackageDescription>
<NDC11Code>61626-0112-04</NDC11Code>
<ProductNDC>61626-0112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visceral Polarity</ProprietaryName>
<NonProprietaryName>Aconitum Nap, Arg Nit, Chininum Pur, Echinacea Purp, Plum Met, Sepia, Sulphuricum Ac</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NET Remedies</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; SILVER NITRATE; QUININE; ECHINACEA PURPUREA; FERRIC FERROCYANIDE; GELSEMIUM SEMPERVIRENS ROOT; HOPS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; LEAD; SEPIA OFFICINALIS JUICE; SULFURIC ACID</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Chelating Activity [MoA], Decorporation Agent [EPC], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS FOR USE: For the temporary relief of lack of general emotional, physical, or mental balance Minor nervous system tension, confusion, nervousness, fatigue Feelings of spasm pressure and tightness sensation in internal organs, esophagus and stomach Temporary relief of heartburn General tone of nervous and digestive systems.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0105-4</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11822-0105-4) > 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11822-0105-04</NDC11Code>
<ProductNDC>11822-0105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Non Aspirin</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970226</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>13630-0105-4</NDCCode>
<PackageDescription>177 mL in 1 CAN (13630-0105-4) </PackageDescription>
<NDC11Code>13630-0105-04</NDC11Code>
<ProductNDC>13630-0105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Australian Gold</ProprietaryName>
<ProprietaryNameSuffix>X-treme Sport Spf 30 C/s Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Packaging Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>25.2; 63; 42; 23.1; 16.8</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; 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>20160407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>15631-0105-4</NDCCode>
<PackageDescription>2500 PELLET in 1 PACKAGE (15631-0105-4) </PackageDescription>
<NDC11Code>15631-0105-04</NDC11Code>
<ProductNDC>15631-0105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cantharis</ProprietaryName>
<NonProprietaryName>Cantharis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151006</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>LYTTA VESICATORIA</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-0105-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-0105-4) </PackageDescription>
<NDC11Code>37662-0105-04</NDC11Code>
<ProductNDC>37662-0105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Nitrica</ProprietaryName>
<NonProprietaryName>Calcarea Nitrica</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220519</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>CALCIUM NITRITE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49288-0105-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0105-4)</PackageDescription>
<NDC11Code>49288-0105-04</NDC11Code>
<ProductNDC>49288-0105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cashew Nut Meat</ProprietaryName>
<NonProprietaryName>Cashew Nut Meat</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>CASHEW</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>50332-0105-4</NDCCode>
<PackageDescription>50 PACKET in 1 BOX, UNIT-DOSE (50332-0105-4) > 2 TABLET in 1 PACKET</PackageDescription>
<NDC11Code>50332-0105-04</NDC11Code>
<ProductNDC>50332-0105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Exaprin</ProprietaryName>
<NonProprietaryName>Acetaminophen, Aspirin, Caffeine, Salicylamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>HART Health</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE; SALICYLAMIDE</SubstanceName>
<StrengthNumber>110; 162; 32.4; 152</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves minor aches and pains due to: 1 headache, 2 backache, 3 muscular aches, 4 minor arthritis pain, 5 the common cold, 6 toothache, 7 menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53104-0105-4</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (53104-0105-4)</PackageDescription>
<NDC11Code>53104-0105-04</NDC11Code>
<ProductNDC>53104-0105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zidovudine</ProprietaryName>
<NonProprietaryName>Zidovudine</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077981</ApplicationNumber>
<LabelerName>Cipla Ltd.</LabelerName>
<SubstanceName>ZIDOVUDINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>58443-0105-4</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE (58443-0105-4) </PackageDescription>
<NDC11Code>58443-0105-04</NDC11Code>
<ProductNDC>58443-0105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Solmate</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130828</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Enterprises, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>19.86; 49.65; 18.3705</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Dictections), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67938-0105-3</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (67938-0105-3) > 15 g in 1 TUBE (67938-0105-4)</PackageDescription>
<NDC11Code>67938-0105-03</NDC11Code>
<ProductNDC>67938-0105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eight Hour Cream Skin Protectant</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Elizabeth Arden, Inc</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>28.4</StrengthNumber>
<StrengthUnit>g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To Use: Apply liberally as often as necessary.</IndicationAndUsage>
<Description>(On Box) Uses: Treats symptoms of: chapping, peeling or flaking due to minor burns, sunburn, windburn, scrapes, abrasions, cracked lips. (On Tube) Soothes minor skin irritations. Also for symptoms of chapping, peeling or flaking due to minor burns, sunburn, windburn, scrapes, abrasions or cracked lips.</Description>
</NDC>
<NDC>
<NDCCode>71335-0105-4</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0105-4) </PackageDescription>
<NDC11Code>71335-0105-04</NDC11Code>
<ProductNDC>71335-0105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202366</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71858-0105-1</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (71858-0105-1) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) </PackageDescription>
<NDC11Code>71858-0105-01</NDC11Code>
<ProductNDC>71858-0105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0105-2</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (71858-0105-2) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) </PackageDescription>
<NDC11Code>71858-0105-02</NDC11Code>
<ProductNDC>71858-0105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>71858-0105-5</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (71858-0105-5) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) </PackageDescription>
<NDC11Code>71858-0105-05</NDC11Code>
<ProductNDC>71858-0105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<ProprietaryNameSuffix>Sol</ProprietaryNameSuffix>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206977</ApplicationNumber>
<LabelerName>IBSA Pharma Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: 1 Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1) , 2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1) .</IndicationAndUsage>
<Description>TIROSINT-SOL (levothyroxine sodium) oral solution contains synthetic L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4NNaO 4 ∙ x H 2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule and is available in the following strengths (mcg/mL): 13, 25, 37.5, 44, 50, 62.5, 75, 88, 100, 112, 125, 137, 150, 175, 200. The inactive ingredients in TIROSINT-SOL are glycerol and water.</Description>
</NDC>
<NDC>
<NDCCode>75318-0105-2</NDCCode>
<PackageDescription>4 DRUM in 1 BOX (75318-0105-2) > 5 L in 1 DRUM (75318-0105-1) </PackageDescription>
<NDC11Code>75318-0105-02</NDC11Code>
<ProductNDC>75318-0105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cela No-clean Hypochlorous Acid Disinfectant</ProprietaryName>
<NonProprietaryName>Hypochlorous Acid Disinfectant</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200424</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Shanghai Wanlay Environmental Protection Technology Co., Ltd.</LabelerName>
<SubstanceName>HYPOCHLOROUS ACID</SubstanceName>
<StrengthNumber>665</StrengthNumber>
<StrengthUnit>mg/5L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0280-0105-01</NDCCode>
<PackageDescription>120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-01) </PackageDescription>
<NDC11Code>00280-0105-01</NDC11Code>
<ProductNDC>0280-0105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aleve Liquid Gels</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214463</ApplicationNumber>
<LabelerName>Bayer Healthcare LLC</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:, 2 minor pain of arthritis, 3 muscular aches, 4 backache, 5 menstrual cramps, 6 headache, 7 toothache, 8 the common cold, 9 temporarily reduces fever.</IndicationAndUsage>
</NDC>
</NDCList>