{
"NDC": [
{
"NDCCode": "66096-712-27",
"PackageDescription": "100 PELLET in 1 KIT (66096-712-27) ",
"NDC11Code": "66096-0712-27",
"ProductNDC": "66096-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Joette Calabrese Survivalist Kit",
"NonProprietaryName": "Abrot Acon Agn Ail Ambr Ambro Am-c Ant-c Apis Arn Ars Aur-a Aur Bapt Bar-c Bell Bb Both Bov Brom Cadm-s Calad Calc Camph Carb-ac Card-m Cean Chel Chinin-a Cina Chin Cic Cob Colch Con Crot-h Crot-t Cupr Dulc Elaps Eup-per Fl-ac Galph Graph Gunp Ham Hekla Hell Hep Hydr-ac Hyos Hyper Kali-br Kali-c Kali-i Lath Laur Led Lob Merc-cy Merc Mez Mosch Mur-ac Naja Nat-c Nit-ac Nux-m Pyrog Ph-ac Pic-ac Plb Rhus-t Ruta Samb Sang Sarr Sep Stram Sul-ac Tab Terent Ter Teucr Verat Verat-v Vip",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151026",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ARTEMISIA ABROTANUM FLOWERING TOP; ACONITUM NAPELLUS; AETHUSA CYNAPIUM; CHASTE TREE; AILANTHUS ALTISSIMA FLOWERING TWIG; AMBERGRIS; AMBROSIA ARTEMISIIFOLIA POLLEN; AMMONIUM CARBONATE; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; GOLD; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; ATROPA BELLADONNA; BORRELIA BURGDORFERI; BOTHROPS ATROX VENOM; LYCOPERDON UTRIFORME FRUITING BODY; BROMINE; CADMIUM SULFATE; DIEFFENBACHIA SEGUINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAMPHOR (NATURAL); PHENOL; MILK THISTLE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; QUININE SULFATE; ARTEMISIA CINA PRE-FLOWERING TOP; CINCHONA OFFICINALIS BARK; CICUTA VIROSA ROOT; COBALT; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; CROTALUS HORRIDUS HORRIDUS VENOM; CROTON TIGLIUM SEED; COPPER; SOLANUM DULCAMARA TOP; MICRURUS CORALLINUS VENOM; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYDROFLUORIC ACID; GALPHIMIA GLAUCA FLOWERING TOP; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HEKLA LAVA; HELLEBORUS NIGER ROOT; CALCIUM SULFIDE; HYDROGEN CYANIDE; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; POTASSIUM BROMIDE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LATHYRUS SATIVAS SEED; PRUNUS LAUROCERASUS LEAF; LEDUM PALUSTRE TWIG; LOBELIA INFLATA; MERCURIC CYANIDE; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; MOSCHUS MOSCHIFERUS WHOLE; HYDROCHLORIC ACID; NAJA NAJA VENOM; SODIUM CARBONATE; NITRIC ACID; NUTMEG; RANCID BEEF; PHOSPHORIC ACID; PICRIC ACID; LEAD; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; SARRACENIA PURPUREA; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; SULFURIC ACID; TOBACCO LEAF; LYCOSA TARANTULA; TURPENTINE OIL; TEUCRIUM MARUM; VERATRUM ALBUM ROOT; VERATRUM VIRIDE ROOT; VIPERA BERUS VENOM",
"StrengthNumber": "6; 1; 200; 200; 30; 30; 30; 30; 6; 1; 3; 3; 200; 200; 30; 3; 200; 30; 30; 30; 30; 30; 1; 200; 6; 30; 30; 6; 3; 3; 3; 30; 30; 30; 3; 6; 30; 6; 30; 30; 200; 30; 30; 200; 200; 30; 30; 6; 30; 6; 1; 30; 200; 6; 30; 30; 1; 30; 200; 6; 200; 30; 30; 30; 30; 30; 30; 200; 6; 200; 30; 1; 6; 30; 200; 30; 6; 6; 30; 30; 30; 30; 6; 200; 200; 30; 30",
"StrengthUnit": "[hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Antimalarial [EPC], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Pollen [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Insect Venom Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151026",
"SamplePackage": "N",
"IndicationAndUsage": "ACTIVE INGREDIENTS (HPUS*) PURPOSE**: ABROTANUM 6C (intestines), ACONITUM NAPELLUS 1M (shock), AETHUSA CYNAPIUM 200C (dairy intolerance), AGNUS CASTUS 200C (impotence/absentmindedness), AILANTHUS GLANDULOSUS 30C (fever/glands), AMBRA GRISEA 30C (confusion/memory), AMBROSIA ARTEMISIAEFOLIA 30C (itchy eyelids), AMMONIUM CARBONICUM 30C (breathing), ANTIMONIUM CRUDUM 6C, 200C (rash), APIS MELLIFICA 1M (swellings), ARNICA MONTANA 3C, 1M (injury), ARSENICUM ALBUM 3C (gastrointestinal), AURUM ARSENICOSUM 200C (infection), AURUM METALLICUM 200C (depression/fatigue), BAPTISIA TINCTORIA 200C (fever/soreness), BARYTA CARBONICA 30C (memory loss), BELLADONNA 3C (pain/fever), BORRELIA BURGDORFERI 200C (tick), BOTHROPS LANCEOLATUS 30C (heart), BOVISTA 30C (suffocation), BROMIUM 30C (radiation), CADMIUM SULPHURICUM 30C (vomiting), CALADIUM SEGUINUM 30C (insect bites), CALCAREA CARBONICA 1M (immunity), CAMPHORA 200C (collapse/antidoting), CARBOLICUM ACIDUM 6C, 30C (infection/swelling), CARDUUS MARIANUS 30C (liver), CEANOTHUS AMERICANUS 30C (radiation/spleen), CHELIDONIUM MAJUS 6C (gastrointestinal), CHININUM SULPHURICUM 3X (fever) CINA 3X, 200C (parasites), CINCHONA (CHINA) OFFICINALIS 3C (fluid loss), CICUTA VIROSA 30C (head injury), COBALTUM METALLICUM 30C (radiation), COLCHICUM AUTUMNALE 30C (dysentery), CONIUM MACULATUM 3C (weakness/growths), CROTALUS HORRIDUS 6C, 30C (hemorrhage), CROTON TIGLIUM 30C (skin eruptions/diarrhea), CUPRUM METALLICUM 6C, 200C (spasms/cramps), DULCAMARA 30C (throat/ringworm), ELAPS CORALLINUS 30C (bleeding), EUPATORIUM PERFOLIATUM 200C (fever), GALPHIMIA GLAUCA 30C (hay fever), GRAPHITES 200C (skin eruptions), GUNPOWDER 30C (infection), HAMAMELIS VIRGINIANA 200C (circulation), HEKLA LAVA 30C (abscessed tooth), HELLEBORUS NIGER 30C (concentration), HEPAR SULPHURIS CALCAREUM 6C (infection), HYDROCYANICUM ACIDUM 30C (rigidity), HYDROFLUORICUM ACIDUM 30C (PTSD, abscess, sleep), HYOSCYAMUS NIGER 6C, 30C (delirium), HYPERICUM PERFORATUM 1M (extreme pain/nerve pain), KALI BROMATUM 30C (staggering), KALI CARBONICUM 200C (respiration), KALI IODATUM 6C (wheezy), LATHYRUS SATIVUS 30C (weakness), LAUROCERASUS 30C (breathlessness/collapse), LEDUM PALUSTRE 1M (puncture injury), LOBELIA INFLATA 30C (breathing difficulty), MERCURIUS CYANATUS 200C (throat), MERCURIUS SOLUBILIS 6C, 200C (throat), MEZEREUM 200C (bones), MOSCHUS 30C (fainting/vertigo), MURIATICUM ACIDUM 30C (weakness/exhaustion), NAJA TRIPUDIANS 30C (heart), NATRUM CARBONICUM 30C (weakness/heat stroke), NITRICUM ACIDUM 30C (anger), NUX MOSCHATA 30C (faintness), PYROGENIUM 200C (infections), PHOSPHORICUM ACIDUM 6C, 200C (exhaustion), PICRICUM ACIDUM 200C (headache/exhaustion), PLUMBUM METALLICUM 30C (weakness/constipation), RHUS TOX 1M (joints), RUTA GRAVEOLENS 6C (tendons), SAMBUCUS NIGRA 30C (breathing/cough), SANGUINARIA CANADENSIS 200C (sinus), SARRACENIA PURPUREA 30C (pustules), SECALE CORNUTUM 6C (internal bleeding), SEPIA 6C (menstrual/headache), STRAMONIUM 30C, 200C (rage), SULPHURICUM ACIDUM 30C (dyspnea), TABACUM 30C, 200C (nausea), TARENTULA HISPANA 30C (restlessness), TEREBINTHINA 6C (urinary problems), TEUCRIUM MARUM 200C (gastrointestinal/nasal), VERATRUM ALBUM 200C (diarrhea/weakness), VERATRUM VIRIDE 30C (infection/pustules), VIPERA BERUS 30C (severe nose bleed)."
},
{
"NDCCode": "51706-712-01",
"PackageDescription": "27 mL in 1 BOTTLE (51706-712-01) ",
"NDC11Code": "51706-0712-01",
"ProductNDC": "51706-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191108",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Landy International",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20191108",
"SamplePackage": "N"
},
{
"NDCCode": "66096-011-32",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-011-32) ",
"NDC11Code": "66096-0011-32",
"ProductNDC": "66096-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anx-ohm",
"NonProprietaryName": "Argentum Nitricum, Avena Sativa, Aurum Metallicum, Gelsemium, Hyosciamus Niger, Ignatia, Moschus, Natrum Muriaticum, Passiflora Incarnata, Stannum Metallicum, Valeriana Officinalis",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SILVER NITRATE; AVENA SATIVA FLOWERING TOP; GOLD; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS WHOLE; SODIUM CHLORIDE; PASSIFLORA INCARNATA TOP; TIN; VALERIAN",
"StrengthNumber": "14; 5; 14; 14; 14; 14; 14; 14; 5; 16; 5",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100101",
"SamplePackage": "N"
},
{
"NDCCode": "66096-174-06",
"PackageDescription": "12 AMPULE in 1 BOX (66096-174-06) > 2.2 mL in 1 AMPULE",
"NDC11Code": "66096-0174-06",
"ProductNDC": "66096-174",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Digestive Terrain",
"NonProprietaryName": "Bryonia Alba, China Officinalis, Hydrastis Canadensis, Kali Bichromicum, Lycopodium Clavatum, Nux Moschata, Nux Vomica, Thuja Occidentalis.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110525",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; NUTMEG; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "7; 5; 7; 8; 8; 6; 7; 9",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110525",
"SamplePackage": "N"
},
{
"NDCCode": "66096-175-06",
"PackageDescription": "12 AMPULE in 1 BOX (66096-175-06) > 2.2 mL in 1 AMPULE",
"NDC11Code": "66096-0175-06",
"ProductNDC": "66096-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Endocrine Feminine Terrain",
"NonProprietaryName": "Cyclamen Europaeum, Erigeron Canadensis, Ignatia Amara, Lachesis Mutus, Moschus, Oophorinum, Pulsatilla, Sepia, Thlaspi Bursa-pastoris, Viburnum Opulus.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120312",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "CYCLAMEN PURPURASCENS TUBER; CONYZA CANADENSIS; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MOSCHUS MOSCHIFERUS WHOLE; SUS SCROFA OVARY; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; CAPSELLA BURSA-PASTORIS; VIBURNUM OPULUS BARK",
"StrengthNumber": "7; 6; 12; 12; 12; 8; 12; 12; 6; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120312",
"SamplePackage": "N"
},
{
"NDCCode": "66096-179-06",
"PackageDescription": "12 AMPULE in 1 BOX (66096-179-06) > 2.2 mL in 1 AMPULE",
"NDC11Code": "66096-0179-06",
"ProductNDC": "66096-179",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Circulatory Terrain",
"NonProprietaryName": "Baryta Iodata, Cactus Grandiflorus, Carbo Vegetabilis, Crataegus Oxyacantha, Curare, Kali Carbonicum, Kalmia Latifolia, Melilotus Officinale, Naja Tripudians, Secale Cornutum, Solanum Nigrum, Spigelia Anthelmia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150423",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "BARIUM IODIDE; SELENICEREUS GRANDIFLORUS STEM; ACTIVATED CHARCOAL; HAWTHORN LEAF WITH FLOWER; TUBOCURARINE CHLORIDE; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; MELILOTUS OFFICINALIS TOP; NAJA NAJA VENOM; CLAVICEPS PURPUREA SCLEROTIUM; SOLANUM NIGRUM TOP; SPIGELIA ANTHELMIA",
"StrengthNumber": "12; 6; 12; 6; 12; 7; 6; 6; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150423",
"SamplePackage": "N"
},
{
"NDCCode": "66096-184-06",
"PackageDescription": "12 AMPULE in 1 BOX (66096-184-06) > 2.2 mL in 1 AMPULE",
"NDC11Code": "66096-0184-06",
"ProductNDC": "66096-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Dermatological Terrain",
"NonProprietaryName": "Calcarea Carbonica, Calcarea Fluorica, Carduus Marianus, China Officinalis, Cynara Scolymus, Galium Aparine, Graphites, Hepar Sulphuris Calcareum, Manganum Phosphoricum, Nicotinamidum, Oleander, Taraxacum Officinale, Thuja Occidentalis.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150413",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; MILK THISTLE; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; GALIUM APARINE; GRAPHITE; CALCIUM SULFIDE; MANGANESE PHOSPHATE, DIBASIC; NIACINAMIDE; NERIUM OLEANDER LEAF; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "12; 12; 5; 5; 8; 8; 12; 12; 8; 7; 6; 6; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150413",
"SamplePackage": "N"
},
{
"NDCCode": "66096-753-02",
"PackageDescription": "30 mL in 1 PACKAGE (66096-753-02) ",
"NDC11Code": "66096-0753-02",
"ProductNDC": "66096-753",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ohm-cir",
"NonProprietaryName": "Baryta Iodata, Cactus Grandiflorus, Carbo Vegetabilis, Crataegus Oxyacantha, Curare, Kali Carbonicum, Kalmia Latifolia, Melilotus Officinale, Naja Tripudians, Secale Cornutum, Solanum Nigrum, Spigelia Anthelmia",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20181219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "BARIUM IODIDE; SELENICEREUS GRANDIFLORUS STEM; ACTIVATED CHARCOAL; HAWTHORN LEAF WITH FLOWER; TUBOCURARINE CHLORIDE; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; MELILOTUS OFFICINALIS TOP; NAJA NAJA VENOM; CLAVICEPS PURPUREA SCLEROTIUM; SOLANUM NIGRUM TOP; SPIGELIA ANTHELMIA",
"StrengthNumber": "12; 6; 12; 6; 12; 7; 6; 6; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Active",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181219",
"SamplePackage": "N",
"IndicationAndUsage": "Contraindicaciones: Ninguna reportada."
},
{
"NDCCode": "66096-757-02",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-757-02) ",
"NDC11Code": "66096-0757-02",
"ProductNDC": "66096-757",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ohm-inma",
"NonProprietaryName": "Aconitum Napellus, Aranea Diadema, Arnica Montana, Asclepias Vincetoxicum, Baptisia Tinctoria, Bryonia Alba, Echinacea Angustifolia, Equisetum Hyemale, Eupatorium Perforliatum, Gelsemium Sempervirens, Hepar Sulphuris Calcareum, Juglans Regia, Phytolacca Decandra, Sanguinaria Canadensis, Sarsaparilla, Sulphur, Zincum Metallicum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20181219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ACONITUM NAPELLUS; ARANEUS DIADEMATUS; ARNICA MONTANA; CYNANCHUM VINCETOXICUM ROOT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; EQUISETUM HYEMALE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; JUGLANS REGIA LEAF; PHYTOLACCA AMERICANA ROOT; SANGUINARIA CANADENSIS ROOT; SARSAPARILLA; SULFUR; ZINC",
"StrengthNumber": "7; 9; 6; 12; 8; 10; 6; 7; 10; 8; 12; 6; 10; 8; 9; 10; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Active",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181219",
"SamplePackage": "N",
"IndicationAndUsage": "Contraindicaciones: Ninguna reportada."
},
{
"NDCCode": "66096-758-02",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-758-02) ",
"NDC11Code": "66096-0758-02",
"ProductNDC": "66096-758",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ohm-ost",
"NonProprietaryName": "Arnica Montana, Calcarea Phosphorica, Causticum, China Officinalis, Colchicum Autumnale, Dulcamara, Ledum Palustre, Rhus Toxicodendron, Symphytum Officinale",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20181219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; COMFREY ROOT",
"StrengthNumber": "4; 12; 12; 12; 12; 6; 7; 12; 8",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181219",
"SamplePackage": "N",
"IndicationAndUsage": "Contraindicaciones: Ninguna reportada."
},
{
"NDCCode": "37000-712-06",
"PackageDescription": "177 mL in 1 BOTTLE, PLASTIC (37000-712-06) ",
"NDC11Code": "37000-0712-06",
"ProductNDC": "37000-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Childrens",
"ProprietaryNameSuffix": "Cough Congestion Night",
"NonProprietaryName": "Phenylephrine Hydrochloride And Diphenhydramine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190422",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "12.5; 5",
"StrengthUnit": "mg/15mL; mg/15mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190422",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold symptoms: 1 nasal congestion, 2 runny nose & sneezing, 3 cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "42507-712-22",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (42507-712-22) ",
"NDC11Code": "42507-0712-22",
"ProductNDC": "42507-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Assorted Berry Antacid",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20260320",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part331",
"LabelerName": "Hyvee Inc",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260320",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "42931-712-01",
"PackageDescription": "1 kg in 1 DRUM (42931-712-01) ",
"NDC11Code": "42931-0712-01",
"ProductNDC": "42931-712",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Inclisiran Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20241126",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Shanghai Desano Chemical Pharmaceutical Co., Ltd.",
"SubstanceName": "INCLISIRAN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-11-27",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "26-NOV-24"
},
{
"NDCCode": "46122-712-60",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (46122-712-60) / 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "46122-0712-60",
"ProductNDC": "46122-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief Sinus Severe Congestion And Pain",
"NonProprietaryName": "Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "AMERISOURCE BERGEN",
"SubstanceName": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220501",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: nasal congestionheadacheminor aches and painssinus congestion and pressure. promotes nasal and/or sinus drainage. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "59923-712-14",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (59923-712-14) / 14 CAPSULE in 1 BOTTLE, GLASS",
"NDC11Code": "59923-0712-14",
"ProductNDC": "59923-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204639",
"LabelerName": "Areva Pharmaceuticals",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190125",
"SamplePackage": "N",
"IndicationAndUsage": "Temozolomide Capsules USP is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1) , 2 Anaplastic astrocytoma. ( 1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2) Treatment of adults with refractory anaplastic astrocytoma. ( 1.2) .",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3methyl-4-oxoimidazo[5,1-d]- as-tetrazine-8-carboxamide. The structural formula is:. The material is a white to light tan/light pink powder with a molecular formula of C 6H 6N 6O 2and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence Temozolomide can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules USP. Temozolomide capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for Temozolomide capsules USP are as follows: 1 Temozolomide capsules USP 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg). , 2 Temozolomide capsules USP 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg). , 3 Temozolomide capsules USP 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg). , 4 Temozolomide capsules USP 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg). , 5 Temozolomide capsules USP 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.2 mg), and stearic acid (10.8 mg). , 6 Temozolomide capsules USP 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg). ."
},
{
"NDCCode": "62135-511-47",
"PackageDescription": "473 mL in 1 BOTTLE (62135-511-47) ",
"NDC11Code": "62135-0511-47",
"ProductNDC": "62135-511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyoscyamine Sulfate",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "ELIXIR",
"RouteName": "ORAL",
"StartMarketingDate": "20220720",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220720",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Oral Drops(Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP(Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USPcontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Sublingual Tabletscontain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tabletscontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. Hyoscyamine Sulfate Oral Dropsalso contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixiralso contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. Hyoscyamine Sulfate Tabletsalso contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate."
},
{
"NDCCode": "62135-512-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (62135-512-12) ",
"NDC11Code": "62135-0512-12",
"ProductNDC": "62135-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyoscyamine Sulfate",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221117",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221117",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Oral Drops(Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP(Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USPcontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Sublingual Tabletscontain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tabletscontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. Hyoscyamine Sulfate Oral Dropsalso contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixiralso contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. Hyoscyamine Sulfate Tabletsalso contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate."
},
{
"NDCCode": "62135-513-52",
"PackageDescription": "20 mL in 1 BOTTLE (62135-513-52) ",
"NDC11Code": "62135-0513-52",
"ProductNDC": "62135-513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyoscyamine Sulfate",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Oral Drops(Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP(Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USPcontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Sublingual Tabletscontain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tabletscontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. Hyoscyamine Sulfate Oral Dropsalso contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixiralso contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. Hyoscyamine Sulfate Tabletsalso contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate."
},
{
"NDCCode": "62135-712-42",
"PackageDescription": "100 mL in 1 BOTTLE (62135-712-42) ",
"NDC11Code": "62135-0712-42",
"ProductNDC": "62135-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OROPHARYNGEAL",
"StartMarketingDate": "20070227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040708",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230616",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine hydrochloride oral topical solution USP, 2% (viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.",
"Description": "Lidocaine Hydrochloride Oral Topical Solution, USP, 2% (viscous) contains a local anesthetic agent and is administered topically. Lidocaine hydrochloride oral topical solution USP, 2% (viscous) contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)- N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula:. The molecular formula of lidocaine is C 14H 22N 2O. The molecular weight is 234.34. COMPOSITION OF SOLUTION. Each mL contains 20 mg of lidocaine HCl, wild cherry flavor, methylparaben, propylparaben, saccharin sodium, sodium carboxymethylcellulose, and sodium hydroxide in purified water. The pH is adjusted to 5.0 to 7.0 with hydrochloric acid and/or sodium hydroxide."
},
{
"NDCCode": "62135-858-12",
"PackageDescription": "120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-858-12) ",
"NDC11Code": "62135-0858-12",
"ProductNDC": "62135-858",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyoscyamine Sulfate",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20240920",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240920",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Oral Drops(Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP(Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USPcontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Sublingual Tabletscontain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tabletscontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. Hyoscyamine Sulfate Oral Dropsalso contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixiralso contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. Hyoscyamine Sulfate Tabletsalso contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate."
},
{
"NDCCode": "62135-859-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (62135-859-12) ",
"NDC11Code": "62135-0859-12",
"ProductNDC": "62135-859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyoscyamine Sulfate Sublingual",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL; SUBLINGUAL",
"StartMarketingDate": "20240920",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240920",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Oral Drops(Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP(Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USPcontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Sublingual Tabletscontain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tabletscontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. Hyoscyamine Sulfate Oral Dropsalso contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixiralso contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. Hyoscyamine Sulfate Tabletsalso contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate."
},
{
"NDCCode": "69423-997-12",
"PackageDescription": "1 KIT in 1 PACKAGE (69423-997-12) * 177 mL in 1 BOTTLE, PLASTIC (69423-982-06) * 177 mL in 1 BOTTLE, PLASTIC (37000-712-06) ",
"NDC11Code": "69423-0997-12",
"ProductNDC": "69423-997",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Childrens",
"ProprietaryNameSuffix": "Cough Congestion",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20190709",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190709",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N"
},
{
"NDCCode": "75313-1028-1",
"PackageDescription": "950 mL in 1 BOTTLE (75313-1028-1) ",
"NDC11Code": "75313-1028-01",
"ProductNDC": "75313-1028",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Covclean 75% Ethyl Alcohol Hand Sanitizer",
"NonProprietaryName": "75% Alcohol Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200427",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Shanghai Nuobang Biotech Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "712.5",
"StrengthUnit": "mL/950mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200427",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "76282-712-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (76282-712-10) ",
"NDC11Code": "76282-0712-10",
"ProductNDC": "76282-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091625",
"LabelerName": "EXELAN PHARMACEUTICALS, INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220310",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide."
},
{
"NDCCode": "76282-712-46",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (76282-712-46) / 10 TABLET, FILM COATED in 1 BLISTER PACK (76282-712-45) ",
"NDC11Code": "76282-0712-46",
"ProductNDC": "76282-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091625",
"LabelerName": "EXELAN PHARMACEUTICALS, INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220310",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide."
},
{
"NDCCode": "76282-712-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (76282-712-50) ",
"NDC11Code": "76282-0712-50",
"ProductNDC": "76282-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091625",
"LabelerName": "EXELAN PHARMACEUTICALS, INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220310",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide."
},
{
"NDCCode": "76282-712-55",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (76282-712-55) ",
"NDC11Code": "76282-0712-55",
"ProductNDC": "76282-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091625",
"LabelerName": "EXELAN PHARMACEUTICALS, INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220310",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide."
},
{
"NDCCode": "76282-712-64",
"PackageDescription": "10000 TABLET, FILM COATED in 1 POUCH (76282-712-64) ",
"NDC11Code": "76282-0712-64",
"ProductNDC": "76282-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091625",
"LabelerName": "EXELAN PHARMACEUTICALS, INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220323",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide."
},
{
"NDCCode": "84756-712-01",
"PackageDescription": "5 g in 1 BOX (84756-712-01) ",
"NDC11Code": "84756-0712-01",
"ProductNDC": "84756-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Turmeric Booster Eye Cream",
"NonProprietaryName": "Turmeric Booster Eye Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-712-02",
"PackageDescription": "15 g in 1 BOX (84756-712-02) ",
"NDC11Code": "84756-0712-02",
"ProductNDC": "84756-712",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Turmeric Booster Eye Cream",
"NonProprietaryName": "Turmeric Booster Eye Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>66096-712-27</NDCCode>
<PackageDescription>100 PELLET in 1 KIT (66096-712-27) </PackageDescription>
<NDC11Code>66096-0712-27</NDC11Code>
<ProductNDC>66096-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Joette Calabrese Survivalist Kit</ProprietaryName>
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<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151026</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ARTEMISIA ABROTANUM FLOWERING TOP; ACONITUM NAPELLUS; AETHUSA CYNAPIUM; CHASTE TREE; AILANTHUS ALTISSIMA FLOWERING TWIG; AMBERGRIS; AMBROSIA ARTEMISIIFOLIA POLLEN; AMMONIUM CARBONATE; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; GOLD; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; ATROPA BELLADONNA; BORRELIA BURGDORFERI; BOTHROPS ATROX VENOM; LYCOPERDON UTRIFORME FRUITING BODY; BROMINE; CADMIUM SULFATE; DIEFFENBACHIA SEGUINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAMPHOR (NATURAL); PHENOL; MILK THISTLE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; QUININE SULFATE; ARTEMISIA CINA PRE-FLOWERING TOP; CINCHONA OFFICINALIS BARK; CICUTA VIROSA ROOT; COBALT; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; CROTALUS HORRIDUS HORRIDUS VENOM; CROTON TIGLIUM SEED; COPPER; SOLANUM DULCAMARA TOP; MICRURUS CORALLINUS VENOM; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYDROFLUORIC ACID; GALPHIMIA GLAUCA FLOWERING TOP; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HEKLA LAVA; HELLEBORUS NIGER ROOT; CALCIUM SULFIDE; HYDROGEN CYANIDE; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; POTASSIUM BROMIDE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LATHYRUS SATIVAS SEED; PRUNUS LAUROCERASUS LEAF; LEDUM PALUSTRE TWIG; LOBELIA INFLATA; MERCURIC CYANIDE; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; MOSCHUS MOSCHIFERUS WHOLE; HYDROCHLORIC ACID; NAJA NAJA VENOM; SODIUM CARBONATE; NITRIC ACID; NUTMEG; RANCID BEEF; PHOSPHORIC ACID; PICRIC ACID; LEAD; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; SARRACENIA PURPUREA; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; SULFURIC ACID; TOBACCO LEAF; LYCOSA TARANTULA; TURPENTINE OIL; TEUCRIUM MARUM; VERATRUM ALBUM ROOT; VERATRUM VIRIDE ROOT; VIPERA BERUS VENOM</SubstanceName>
<StrengthNumber>6; 1; 200; 200; 30; 30; 30; 30; 6; 1; 3; 3; 200; 200; 30; 3; 200; 30; 30; 30; 30; 30; 1; 200; 6; 30; 30; 6; 3; 3; 3; 30; 30; 30; 3; 6; 30; 6; 30; 30; 200; 30; 30; 200; 200; 30; 30; 6; 30; 6; 1; 30; 200; 6; 30; 30; 1; 30; 200; 6; 200; 30; 30; 30; 30; 30; 30; 200; 6; 200; 30; 1; 6; 30; 200; 30; 6; 6; 30; 30; 30; 30; 6; 200; 200; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Antimalarial [EPC], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Pollen [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Insect Venom Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ACTIVE INGREDIENTS (HPUS*) PURPOSE**: ABROTANUM 6C (intestines), ACONITUM NAPELLUS 1M (shock), AETHUSA CYNAPIUM 200C (dairy intolerance), AGNUS CASTUS 200C (impotence/absentmindedness), AILANTHUS GLANDULOSUS 30C (fever/glands), AMBRA GRISEA 30C (confusion/memory), AMBROSIA ARTEMISIAEFOLIA 30C (itchy eyelids), AMMONIUM CARBONICUM 30C (breathing), ANTIMONIUM CRUDUM 6C, 200C (rash), APIS MELLIFICA 1M (swellings), ARNICA MONTANA 3C, 1M (injury), ARSENICUM ALBUM 3C (gastrointestinal), AURUM ARSENICOSUM 200C (infection), AURUM METALLICUM 200C (depression/fatigue), BAPTISIA TINCTORIA 200C (fever/soreness), BARYTA CARBONICA 30C (memory loss), BELLADONNA 3C (pain/fever), BORRELIA BURGDORFERI 200C (tick), BOTHROPS LANCEOLATUS 30C (heart), BOVISTA 30C (suffocation), BROMIUM 30C (radiation), CADMIUM SULPHURICUM 30C (vomiting), CALADIUM SEGUINUM 30C (insect bites), CALCAREA CARBONICA 1M (immunity), CAMPHORA 200C (collapse/antidoting), CARBOLICUM ACIDUM 6C, 30C (infection/swelling), CARDUUS MARIANUS 30C (liver), CEANOTHUS AMERICANUS 30C (radiation/spleen), CHELIDONIUM MAJUS 6C (gastrointestinal), CHININUM SULPHURICUM 3X (fever) CINA 3X, 200C (parasites), CINCHONA (CHINA) OFFICINALIS 3C (fluid loss), CICUTA VIROSA 30C (head injury), COBALTUM METALLICUM 30C (radiation), COLCHICUM AUTUMNALE 30C (dysentery), CONIUM MACULATUM 3C (weakness/growths), CROTALUS HORRIDUS 6C, 30C (hemorrhage), CROTON TIGLIUM 30C (skin eruptions/diarrhea), CUPRUM METALLICUM 6C, 200C (spasms/cramps), DULCAMARA 30C (throat/ringworm), ELAPS CORALLINUS 30C (bleeding), EUPATORIUM PERFOLIATUM 200C (fever), GALPHIMIA GLAUCA 30C (hay fever), GRAPHITES 200C (skin eruptions), GUNPOWDER 30C (infection), HAMAMELIS VIRGINIANA 200C (circulation), HEKLA LAVA 30C (abscessed tooth), HELLEBORUS NIGER 30C (concentration), HEPAR SULPHURIS CALCAREUM 6C (infection), HYDROCYANICUM ACIDUM 30C (rigidity), HYDROFLUORICUM ACIDUM 30C (PTSD, abscess, sleep), HYOSCYAMUS NIGER 6C, 30C (delirium), HYPERICUM PERFORATUM 1M (extreme pain/nerve pain), KALI BROMATUM 30C (staggering), KALI CARBONICUM 200C (respiration), KALI IODATUM 6C (wheezy), LATHYRUS SATIVUS 30C (weakness), LAUROCERASUS 30C (breathlessness/collapse), LEDUM PALUSTRE 1M (puncture injury), LOBELIA INFLATA 30C (breathing difficulty), MERCURIUS CYANATUS 200C (throat), MERCURIUS SOLUBILIS 6C, 200C (throat), MEZEREUM 200C (bones), MOSCHUS 30C (fainting/vertigo), MURIATICUM ACIDUM 30C (weakness/exhaustion), NAJA TRIPUDIANS 30C (heart), NATRUM CARBONICUM 30C (weakness/heat stroke), NITRICUM ACIDUM 30C (anger), NUX MOSCHATA 30C (faintness), PYROGENIUM 200C (infections), PHOSPHORICUM ACIDUM 6C, 200C (exhaustion), PICRICUM ACIDUM 200C (headache/exhaustion), PLUMBUM METALLICUM 30C (weakness/constipation), RHUS TOX 1M (joints), RUTA GRAVEOLENS 6C (tendons), SAMBUCUS NIGRA 30C (breathing/cough), SANGUINARIA CANADENSIS 200C (sinus), SARRACENIA PURPUREA 30C (pustules), SECALE CORNUTUM 6C (internal bleeding), SEPIA 6C (menstrual/headache), STRAMONIUM 30C, 200C (rage), SULPHURICUM ACIDUM 30C (dyspnea), TABACUM 30C, 200C (nausea), TARENTULA HISPANA 30C (restlessness), TEREBINTHINA 6C (urinary problems), TEUCRIUM MARUM 200C (gastrointestinal/nasal), VERATRUM ALBUM 200C (diarrhea/weakness), VERATRUM VIRIDE 30C (infection/pustules), VIPERA BERUS 30C (severe nose bleed).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51706-712-01</NDCCode>
<PackageDescription>27 mL in 1 BOTTLE (51706-712-01) </PackageDescription>
<NDC11Code>51706-0712-01</NDC11Code>
<ProductNDC>51706-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Landy International</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-011-32</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-011-32) </PackageDescription>
<NDC11Code>66096-0011-32</NDC11Code>
<ProductNDC>66096-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anx-ohm</ProprietaryName>
<NonProprietaryName>Argentum Nitricum, Avena Sativa, Aurum Metallicum, Gelsemium, Hyosciamus Niger, Ignatia, Moschus, Natrum Muriaticum, Passiflora Incarnata, Stannum Metallicum, Valeriana Officinalis</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SILVER NITRATE; AVENA SATIVA FLOWERING TOP; GOLD; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS WHOLE; SODIUM CHLORIDE; PASSIFLORA INCARNATA TOP; TIN; VALERIAN</SubstanceName>
<StrengthNumber>14; 5; 14; 14; 14; 14; 14; 14; 5; 16; 5</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-174-06</NDCCode>
<PackageDescription>12 AMPULE in 1 BOX (66096-174-06) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>66096-0174-06</NDC11Code>
<ProductNDC>66096-174</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Digestive Terrain</ProprietaryName>
<NonProprietaryName>Bryonia Alba, China Officinalis, Hydrastis Canadensis, Kali Bichromicum, Lycopodium Clavatum, Nux Moschata, Nux Vomica, Thuja Occidentalis.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110525</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; NUTMEG; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>7; 5; 7; 8; 8; 6; 7; 9</StrengthNumber>
<StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-175-06</NDCCode>
<PackageDescription>12 AMPULE in 1 BOX (66096-175-06) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>66096-0175-06</NDC11Code>
<ProductNDC>66096-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Endocrine Feminine Terrain</ProprietaryName>
<NonProprietaryName>Cyclamen Europaeum, Erigeron Canadensis, Ignatia Amara, Lachesis Mutus, Moschus, Oophorinum, Pulsatilla, Sepia, Thlaspi Bursa-pastoris, Viburnum Opulus.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120312</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>CYCLAMEN PURPURASCENS TUBER; CONYZA CANADENSIS; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MOSCHUS MOSCHIFERUS WHOLE; SUS SCROFA OVARY; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; CAPSELLA BURSA-PASTORIS; VIBURNUM OPULUS BARK</SubstanceName>
<StrengthNumber>7; 6; 12; 12; 12; 8; 12; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-179-06</NDCCode>
<PackageDescription>12 AMPULE in 1 BOX (66096-179-06) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>66096-0179-06</NDC11Code>
<ProductNDC>66096-179</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Circulatory Terrain</ProprietaryName>
<NonProprietaryName>Baryta Iodata, Cactus Grandiflorus, Carbo Vegetabilis, Crataegus Oxyacantha, Curare, Kali Carbonicum, Kalmia Latifolia, Melilotus Officinale, Naja Tripudians, Secale Cornutum, Solanum Nigrum, Spigelia Anthelmia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150423</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>BARIUM IODIDE; SELENICEREUS GRANDIFLORUS STEM; ACTIVATED CHARCOAL; HAWTHORN LEAF WITH FLOWER; TUBOCURARINE CHLORIDE; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; MELILOTUS OFFICINALIS TOP; NAJA NAJA VENOM; CLAVICEPS PURPUREA SCLEROTIUM; SOLANUM NIGRUM TOP; SPIGELIA ANTHELMIA</SubstanceName>
<StrengthNumber>12; 6; 12; 6; 12; 7; 6; 6; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-184-06</NDCCode>
<PackageDescription>12 AMPULE in 1 BOX (66096-184-06) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>66096-0184-06</NDC11Code>
<ProductNDC>66096-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Dermatological Terrain</ProprietaryName>
<NonProprietaryName>Calcarea Carbonica, Calcarea Fluorica, Carduus Marianus, China Officinalis, Cynara Scolymus, Galium Aparine, Graphites, Hepar Sulphuris Calcareum, Manganum Phosphoricum, Nicotinamidum, Oleander, Taraxacum Officinale, Thuja Occidentalis.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150413</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; MILK THISTLE; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; GALIUM APARINE; GRAPHITE; CALCIUM SULFIDE; MANGANESE PHOSPHATE, DIBASIC; NIACINAMIDE; NERIUM OLEANDER LEAF; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>12; 12; 5; 5; 8; 8; 12; 12; 8; 7; 6; 6; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-753-02</NDCCode>
<PackageDescription>30 mL in 1 PACKAGE (66096-753-02) </PackageDescription>
<NDC11Code>66096-0753-02</NDC11Code>
<ProductNDC>66096-753</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ohm-cir</ProprietaryName>
<NonProprietaryName>Baryta Iodata, Cactus Grandiflorus, Carbo Vegetabilis, Crataegus Oxyacantha, Curare, Kali Carbonicum, Kalmia Latifolia, Melilotus Officinale, Naja Tripudians, Secale Cornutum, Solanum Nigrum, Spigelia Anthelmia</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>BARIUM IODIDE; SELENICEREUS GRANDIFLORUS STEM; ACTIVATED CHARCOAL; HAWTHORN LEAF WITH FLOWER; TUBOCURARINE CHLORIDE; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; MELILOTUS OFFICINALIS TOP; NAJA NAJA VENOM; CLAVICEPS PURPUREA SCLEROTIUM; SOLANUM NIGRUM TOP; SPIGELIA ANTHELMIA</SubstanceName>
<StrengthNumber>12; 6; 12; 6; 12; 7; 6; 6; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Contraindicaciones: Ninguna reportada.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-757-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-757-02) </PackageDescription>
<NDC11Code>66096-0757-02</NDC11Code>
<ProductNDC>66096-757</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ohm-inma</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Aranea Diadema, Arnica Montana, Asclepias Vincetoxicum, Baptisia Tinctoria, Bryonia Alba, Echinacea Angustifolia, Equisetum Hyemale, Eupatorium Perforliatum, Gelsemium Sempervirens, Hepar Sulphuris Calcareum, Juglans Regia, Phytolacca Decandra, Sanguinaria Canadensis, Sarsaparilla, Sulphur, Zincum Metallicum</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARANEUS DIADEMATUS; ARNICA MONTANA; CYNANCHUM VINCETOXICUM ROOT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; EQUISETUM HYEMALE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; JUGLANS REGIA LEAF; PHYTOLACCA AMERICANA ROOT; SANGUINARIA CANADENSIS ROOT; SARSAPARILLA; SULFUR; ZINC</SubstanceName>
<StrengthNumber>7; 9; 6; 12; 8; 10; 6; 7; 10; 8; 12; 6; 10; 8; 9; 10; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Contraindicaciones: Ninguna reportada.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-758-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-758-02) </PackageDescription>
<NDC11Code>66096-0758-02</NDC11Code>
<ProductNDC>66096-758</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ohm-ost</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calcarea Phosphorica, Causticum, China Officinalis, Colchicum Autumnale, Dulcamara, Ledum Palustre, Rhus Toxicodendron, Symphytum Officinale</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; COMFREY ROOT</SubstanceName>
<StrengthNumber>4; 12; 12; 12; 12; 6; 7; 12; 8</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Contraindicaciones: Ninguna reportada.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37000-712-06</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE, PLASTIC (37000-712-06) </PackageDescription>
<NDC11Code>37000-0712-06</NDC11Code>
<ProductNDC>37000-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Childrens</ProprietaryName>
<ProprietaryNameSuffix>Cough Congestion Night</ProprietaryNameSuffix>
<NonProprietaryName>Phenylephrine Hydrochloride And Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190422</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 5</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190422</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold symptoms: 1 nasal congestion, 2 runny nose & sneezing, 3 cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42507-712-22</NDCCode>
<PackageDescription>96 TABLET, CHEWABLE in 1 BOTTLE (42507-712-22) </PackageDescription>
<NDC11Code>42507-0712-22</NDC11Code>
<ProductNDC>42507-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Assorted Berry Antacid</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260320</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Hyvee Inc</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 acid indigestion, 2 heartburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42931-712-01</NDCCode>
<PackageDescription>1 kg in 1 DRUM (42931-712-01) </PackageDescription>
<NDC11Code>42931-0712-01</NDC11Code>
<ProductNDC>42931-712</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Inclisiran Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20241126</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Shanghai Desano Chemical Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>INCLISIRAN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-11-27</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>26-NOV-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>46122-712-60</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (46122-712-60) / 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46122-0712-60</NDC11Code>
<ProductNDC>46122-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief Sinus Severe Congestion And Pain</ProprietaryName>
<NonProprietaryName>Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>AMERISOURCE BERGEN</LabelerName>
<SubstanceName>ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: nasal congestionheadacheminor aches and painssinus congestion and pressure. promotes nasal and/or sinus drainage. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59923-712-14</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (59923-712-14) / 14 CAPSULE in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59923-0712-14</NDC11Code>
<ProductNDC>59923-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204639</ApplicationNumber>
<LabelerName>Areva Pharmaceuticals</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temozolomide Capsules USP is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1) , 2 Anaplastic astrocytoma. ( 1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2) Treatment of adults with refractory anaplastic astrocytoma. ( 1.2) .</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3methyl-4-oxoimidazo[5,1-d]- as-tetrazine-8-carboxamide. The structural formula is:. The material is a white to light tan/light pink powder with a molecular formula of C 6H 6N 6O 2and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence Temozolomide can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules USP. Temozolomide capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for Temozolomide capsules USP are as follows: 1 Temozolomide capsules USP 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg). , 2 Temozolomide capsules USP 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg). , 3 Temozolomide capsules USP 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg). , 4 Temozolomide capsules USP 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg). , 5 Temozolomide capsules USP 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.2 mg), and stearic acid (10.8 mg). , 6 Temozolomide capsules USP 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg). .</Description>
</NDC>
<NDC>
<NDCCode>62135-511-47</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (62135-511-47) </PackageDescription>
<NDC11Code>62135-0511-47</NDC11Code>
<ProductNDC>62135-511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamine Sulfate</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>ELIXIR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220720</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Oral Drops(Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP(Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USPcontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Sublingual Tabletscontain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tabletscontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. Hyoscyamine Sulfate Oral Dropsalso contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixiralso contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. Hyoscyamine Sulfate Tabletsalso contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-512-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (62135-512-12) </PackageDescription>
<NDC11Code>62135-0512-12</NDC11Code>
<ProductNDC>62135-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamine Sulfate</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221117</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Oral Drops(Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP(Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USPcontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Sublingual Tabletscontain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tabletscontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. Hyoscyamine Sulfate Oral Dropsalso contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixiralso contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. Hyoscyamine Sulfate Tabletsalso contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-513-52</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE (62135-513-52) </PackageDescription>
<NDC11Code>62135-0513-52</NDC11Code>
<ProductNDC>62135-513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamine Sulfate</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Oral Drops(Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP(Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USPcontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Sublingual Tabletscontain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tabletscontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. Hyoscyamine Sulfate Oral Dropsalso contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixiralso contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. Hyoscyamine Sulfate Tabletsalso contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate.</Description>
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<NDC>
<NDCCode>62135-712-42</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (62135-712-42) </PackageDescription>
<NDC11Code>62135-0712-42</NDC11Code>
<ProductNDC>62135-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OROPHARYNGEAL</RouteName>
<StartMarketingDate>20070227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040708</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine hydrochloride oral topical solution USP, 2% (viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Oral Topical Solution, USP, 2% (viscous) contains a local anesthetic agent and is administered topically. Lidocaine hydrochloride oral topical solution USP, 2% (viscous) contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)- N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula:. The molecular formula of lidocaine is C 14H 22N 2O. The molecular weight is 234.34. COMPOSITION OF SOLUTION. Each mL contains 20 mg of lidocaine HCl, wild cherry flavor, methylparaben, propylparaben, saccharin sodium, sodium carboxymethylcellulose, and sodium hydroxide in purified water. The pH is adjusted to 5.0 to 7.0 with hydrochloric acid and/or sodium hydroxide.</Description>
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<ProprietaryName>Hyoscyamine Sulfate</ProprietaryName>
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<StartMarketingDate>20240920</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Oral Drops(Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP(Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USPcontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Sublingual Tabletscontain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tabletscontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. Hyoscyamine Sulfate Oral Dropsalso contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixiralso contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. Hyoscyamine Sulfate Tabletsalso contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-859-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (62135-859-12) </PackageDescription>
<NDC11Code>62135-0859-12</NDC11Code>
<ProductNDC>62135-859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamine Sulfate Sublingual</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20240920</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Oral Drops(Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP(Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USPcontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Sublingual Tabletscontain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tabletscontain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17H 23NO 3) 2 H 2SO 4 2H 2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure:. Hyoscyamine Sulfate Oral Dropsalso contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixiralso contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. Hyoscyamine Sulfate Tabletsalso contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tabletsalso contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate.</Description>
</NDC>
<NDC>
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<PackageDescription>1 KIT in 1 PACKAGE (69423-997-12) * 177 mL in 1 BOTTLE, PLASTIC (69423-982-06) * 177 mL in 1 BOTTLE, PLASTIC (37000-712-06) </PackageDescription>
<NDC11Code>69423-0997-12</NDC11Code>
<ProductNDC>69423-997</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Childrens</ProprietaryName>
<ProprietaryNameSuffix>Cough Congestion</ProprietaryNameSuffix>
<NonProprietaryName>Dextromethorphan Hydrobromide, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190709</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190709</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>75313-1028-1</NDCCode>
<PackageDescription>950 mL in 1 BOTTLE (75313-1028-1) </PackageDescription>
<NDC11Code>75313-1028-01</NDC11Code>
<ProductNDC>75313-1028</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Covclean 75% Ethyl Alcohol Hand Sanitizer</ProprietaryName>
<NonProprietaryName>75% Alcohol Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200427</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Shanghai Nuobang Biotech Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>712.5</StrengthNumber>
<StrengthUnit>mL/950mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76282-712-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (76282-712-10) </PackageDescription>
<NDC11Code>76282-0712-10</NDC11Code>
<ProductNDC>76282-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091625</ApplicationNumber>
<LabelerName>EXELAN PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</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>2024-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76282-712-46</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (76282-712-46) / 10 TABLET, FILM COATED in 1 BLISTER PACK (76282-712-45) </PackageDescription>
<NDC11Code>76282-0712-46</NDC11Code>
<ProductNDC>76282-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091625</ApplicationNumber>
<LabelerName>EXELAN PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</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>2024-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76282-712-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76282-712-50) </PackageDescription>
<NDC11Code>76282-0712-50</NDC11Code>
<ProductNDC>76282-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091625</ApplicationNumber>
<LabelerName>EXELAN PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</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>2024-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.</Description>
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<NDCCode>76282-712-55</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (76282-712-55) </PackageDescription>
<NDC11Code>76282-0712-55</NDC11Code>
<ProductNDC>76282-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091625</ApplicationNumber>
<LabelerName>EXELAN PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</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>2024-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76282-712-64</NDCCode>
<PackageDescription>10000 TABLET, FILM COATED in 1 POUCH (76282-712-64) </PackageDescription>
<NDC11Code>76282-0712-64</NDC11Code>
<ProductNDC>76282-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091625</ApplicationNumber>
<LabelerName>EXELAN PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>84756-712-01</NDCCode>
<PackageDescription>5 g in 1 BOX (84756-712-01) </PackageDescription>
<NDC11Code>84756-0712-01</NDC11Code>
<ProductNDC>84756-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Turmeric Booster Eye Cream</ProprietaryName>
<NonProprietaryName>Turmeric Booster Eye Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-712-02</NDCCode>
<PackageDescription>15 g in 1 BOX (84756-712-02) </PackageDescription>
<NDC11Code>84756-0712-02</NDC11Code>
<ProductNDC>84756-712</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Turmeric Booster Eye Cream</ProprietaryName>
<NonProprietaryName>Turmeric Booster Eye Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
</NDCList>